buprenorphine and Chronic-Pain

The crisis caused by prescribed opioids and their related side effects are a public health problem worldwide. Most of these are prescribed for coping with chronic pain. The coexistence of opioid use disorder (OUD) in patients with chronic pain represents a complex challenge due to the need for managing both pain and OUD. The aim of this systematic review is to evaluate the efficacy of feasible treatments for this population with OUD and comorbid chronic pain for both conditions. A systematic database search has been performed using Cochrane Library, MEDLINE, PsycINFO and ClinicalTrials.gov in compliance with PRISMA guidelines. Eligible articles addressed the outcomes in chronic pain patients with comorbid opioid use disorder after treatment interventions were applied. Of 593 identified articles, nine were eligible for qualitative review (n = 7 pharmacological interventions; n = 2 psychological interventions). Methadone, buprenorphine, cognitive-behavioral and mindfulness showed promising results, but data were inconclusive (<2 RCT with low risk of bias). It is unclear whether the opioid agonist treatment should be maintained or tapered and which drug should be prescribed for the opioid substitution therapy (methadone or buprenorphine/naloxone). Mindfulness and cognitive behavioral therapy have a discrete effect on improving negative affect but not pain. The therapeutic approach might be individualized under a shared decision-making basis.. La crisis causada por los opioides recetados y sus efectos secundarios relacionados son un problema de salud pública en todo el mundo. La mayoría de estos medicamentos se recetan para el afrontamiento del dolor crónico. La coexistencia del trastorno por uso de opioides (TUO) en pacientes con dolor crónico representa un desafío complejo debido a la necesidad de controlar tanto el dolor como el TUO. El objetivo de esta revisión sistemática es evaluar la eficacia de los tratamientos posibles para dicha población con TUO y dolor crónico. Se ha realizado una revisión sistemática usando las bases de datos Cochrane Library, MEDLINE, PsycINFO y ClinicalTrials.gov, conforme a las pautas PRISMA. Los artículos elegibles abordaron los resultados en pacientes con dolor crónico y diagnóstico comórbido de TUO, después de aplicar una intervención. De 593 artículos identificados, nueve eran elegibles para la revisión cualitativa (n = 7 intervenciones farmacológicas; n = 2 intervenciones psicológicas). La metadona, la buprenorfina, la terapia cognitivo-conductual y el mindfulness mostraron resultados prometedores, pero los datos no eran concluyentes (<2 ECA con bajo riesgo de sesgo). No está claro si el tratamiento con agonistas opioides debe mantenerse o disminuirse y qué fármaco debe prescribirse para la terapia de sustitución de opioides (metadona o buprenorfina/naloxona). El mindfulness y la terapia cognitivo-conductual tienen un efecto discreto en la mejora del afecto negativo, pero no del dolor. El enfoque terapéutico podría individualizarse sobre la base de una toma de decisiones conjunta.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders

To assess studies examining the prevalence of chronic pain (CP) in patients treated with Opioid Substitution Treatment (OST - buprenorphine or methadone) for Opioid Used Disorder (OUD), we conducted a systematic review and meta-analysis of the literature between the years 2000 and 2020. We searched EMBASE, PsycINFO, Cochrane, and MEDLINE databases and included studies assessing the prevalence of CP in OUD adults treated with OST. The studies were assessed for risk of bias and overall quality and the results were pooled using a random-effects model. Subgroup analyses and meta-regressions were used to identify possible factors associated with CP. Twenty-three studies reported data on the prevalence of CP in patients treated with OST were evaluated. The prevalence obtained was 45.3% (CI95% [38.7; 52.1]). Overall, 78.3% of the studies had a low risk of bias. Subgroup analysis estimates did not vary according to gender, OST, and CP duration. However, it appeared that the clinical settings was associated with a lower CP prevalence when assessed in primary care sites. Our study provided an estimate regarding the prevalence of CP among OST patients. These patients deserve specific attention from health professionals and health authorities. Thus, the real challenge in OST patients is the implementation of a multidisciplinary approach to manage CP. PERSPECTIVE: Our meta-analysis provided an estimate of CP prevalence, reaching almost 50% of OUD patients with OST. Thus, the urgent challenge in OST patients is to pay systematic attention to chronic pain diagnosis, along with the implementation of a multidisciplinary patient-focused approach for an appropriate management of CP. REGISTRATION: PROSPERO (CRD42021284790).

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Prevalence

Buprenorphine is a partial agonist at the µ-opioid receptor and an antagonist at the delta and kappa opioid receptors. It has high affinity and low intrinsic activity at the µ-opioid receptor. Buprenorphine demonstrates no ceiling effect for clinical analgesia, but demonstrates this for respiratory depression and euphoria. It may provide effective analgesia while producing less adverse effects, making it a promising opioid analgesic. A systematic review and meta-analysis were performed to examine the analgesic efficacy of buprenorphine for patients with chronic noncancer pain.. PubMed, MEDLNE, Embase, and the Cochrane Library were searched up to January 2022. Randomized controlled trials were included if they compared buprenorphine versus placebo or active analgesic in patients with chronic noncancer pain, where pain score was an outcome. Nonrandomized controlled trials, observational studies, qualitative studies, case reports, and commentaries were excluded. Two investigators independently performed the literature search, study selection, and data collection. A random-effects model was used. The primary outcome was the effect of buprenorphine on pain intensity in patients with chronic noncancer pain based on standardized mean difference (SMD) in pain score. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach.. Two separate literature searches were conducted for patients with and without opioid use disorder (OUD). Only one study met the search criteria for those with OUD. Fourteen randomized controlled trials were included for those without OUD. Buprenorphine was associated with reduced pain score (SMD = -0.368, P < .001, I 2 = 89.37%) compared to placebo or active analgesic. Subgroup meta-analyses showed statistically significant differences in favor of buprenorphine versus placebo (SMD = -0.404, P < .001), for chronic low back pain (SMD = -0.383, P < .001), when administered via the transdermal route (SMD = -0.572, P = .001), via the buccal route (SMD = -0.453, P < .001), with length of follow-up lasting <12 weeks (SMD = -0.848, P < .05), and length of follow-up lasting 12 weeks or more (SMD = -0.415, P < .001). There was no significant difference when compared to active analgesic (SMD = 0.045, P > .05). Quality of evidence was low to moderate.. Buprenorphine was associated with a statistically significant and small reduction in pain intensity compared to placebo. Both the transdermal and buccal routes provided pain relief. There was more evidence supporting its use for chronic low back pain.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Low Back Pain; Opioid-Related Disorders; Randomized Controlled Trials as Topic; Receptors, Opioid

Collaborative care management (CCM) is an empirically driven model to overcome fractured medical care and improve health outcomes. While CCM has been applied across numerous conditions, it remains underused for chronic pain and opioid use. Our objective was to establish the state of the science for CCM approaches to addressing pain-related outcomes and opioid-related behaviors through a systematic review.. We identified peer-reviewed articles from Cochrane, Embase, PsycINFO, and PubMed databases from January 1, 1995, to October 31, 2022. Abstracts and full-text articles were screened for study inclusion, resulting in 18 studies for the final review. In addition, authors used the Patient-Centered Integrated Behavioral Health Care Principles and Tasks Checklist as a tool for assessing the reported CCM components within and across studies. We conducted this systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement.. Several CCM trials evidenced statistically significant improvements in pain-related outcomes (n = 11), such as pain severity and pain-related activity interference. However, effect sizes varied considerably across studies and some effects were not clinically meaningful. CCM had some success in targeting opioid-related behaviors (n = 4), including reduction in opioid prescription dose. Other opioid-related work focused on CCM to facilitate buprenorphine treatment for opioid use disorder (n = 2), including improved odds of receiving treatment and greater prevalence of abstinence from opioids and alcohol. Uniquely, several interventions used CCM to target mental health as a way to address pain (n = 10). Generally, there was moderate alignment with the CCM model.. CCM shows promise for improving pain-related outcomes, as well as facilitating buprenorphine for opioid use disorder. More robust research is needed to determine which aspects of CCM best support improved outcomes and how to maximize the effectiveness of such interventions.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders; Primary Health Care

Buprenorphine possesses many unique attributes that make it a practical agent for adults and adolescents with opioid use disorder (OUD) and/or acute or chronic pain. Sublingual buprenorphine has been the standard of care for treating OUD, but its use in pain management is not as clearly defined. Current practice guidelines recommend a period of mild-to-moderate withdrawal from opioids before transitioning to buprenorphine due to its ability to displace full agonists from the μ-opioid receptor. However, this strategy can lead to negative physical and psychological outcomes for patients. Novel initiation strategies suggest that concomitant administration of small doses of buprenorphine with opioids can avoid the unwanted withdrawal associated with buprenorphine initiation. We aim to systematically review the buprenorphine initiation strategies that have emerged in the last decade. Embase, PubMed, and Cochrane Databases were searched for relevant literature. Studies were included if they were published in the English language and described the transition to buprenorphine from opioids. Data were collected from each study and synthesized using descriptive statistics. This review included 7 observational studies, 1 feasibility study, and 39 case reports/series which included 924 patients. The strategies utilized between the literature included traditional initiation (47.9%), microdosing with various buprenorphine formulations (16%), and miscellaneous methods (36.1%). Traditional initiation and microdosing initiation were compared in the data synthesis and analysis; miscellaneous methods were omitted given the high variability between methods. Overall, 95.6% of patients in the traditional initiation group and 96% of patients in the microdosing group successfully rotated to sublingual buprenorphine. Initiation regimens can vary widely depending on patient-specific factors and buprenorphine formulation. A variety of buprenorphine transition strategies are published in the literature, many of which were effective for patients with OUD, pain, or both.

Topics: Adolescent; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Observational Studies as Topic; Opioid-Related Disorders; Pain Management

Rates of opioid misuse and opioid use disorder have been increasing in recent years. Buprenorphine has emerged as an appealing medication for its use not only as treatment for opioid use disorder, but also as an opioid for chronic pain that has a ceiling effect on risks associated with opioid therapy. As other opioid prescribing decreases, buprenorphine prescribing continues to increase. As a result, it is imperative to understand the safety and efficacy of its use in special populations. This review article will explore the safety and efficacy of buprenorphine when used in subjects with hepatic and renal impairment, the elderly, and pregnant women. While manufacturer labeling for buprenorphine products may caution against their use in these populations, further examination of available data indicates that buprenorphine can be used safely and effectively for both chronic pain and/or opioid use disorder in all four of these populations.

Topics: Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Opioid-Related Disorders; Practice Patterns, Physicians'; Pregnancy

The United States underwent massive expansion in opioid prescribing from 1990-2010, followed by opioid stewardship initiatives and reduced prescribing. Opioids are no longer considered first-line therapy for most chronic pain conditions and clinicians should first seek alternatives in most circumstances. Patients who have been treated with opioids long-term should be managed differently, sometimes even continued on opioids due to physiologic changes wrought by long-term opioid therapy and documented risks of discontinuation. When providing long-term opioid therapy, clinicians should document opioid stewardship measures, including assessments, consents, medication reconciliation, and offering naloxone, along with the rationale to continue opioid therapy. Clinicians should screen regularly for opioid use disorder and arrange for or directly provide treatment. In particular, buprenorphine can be highly useful for co-morbid pain and opioid use disorder. Addressing other substance use disorders, as well as preventive health related to substance use, should be a priority in patients with opioid use disorder. Patient-centered practices, such as shared decision-making and attending to related facets of a patient's life that influence health outcomes, should be implemented at all points of care.Key messagesAlthough opioids are no longer considered first-line therapy for most chronic pain, management of patients already taking long-term opioid therapy must be individualised.Documentation of opioid stewardship measures can help to organise opioid prescribing and protect clinicians from regulatory scrutiny.Management of resultant opioid use disorder should include provision of medications, most often buprenorphine, and several additional screening and preventive measures.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Naloxone; Opioid-Related Disorders; Practice Patterns, Physicians'; Primary Health Care; United States

Opioid use disorder and chronic pain are increasingly commonly encountered in medicine and many patients now are prescribed medications (such as buprenorphine) to help treat these conditions. Many radiologists are unfamiliar with how these medications work and how they impact providing procedural sedation during procedures in the radiology department. The focus of this manuscript is to provide radiologists background and guidance on how these medications interact with medications given for procedural sedation and the appropriate management strategy for patients with opioid use disorder and chronic pain who require procedural sedation.

Topics: Buprenorphine; Chronic Pain; Conscious Sedation; Humans; Opioid-Related Disorders; Radiologists

Buprenorphine has unique and favorable pharmacological properties that make it useful in a variety of clinical scenarios. It has been recommended to consider buprenorphine first-line opioid for chronic pain, especially in the elderly as it may be associated with less cognitive impairment, falls, sexual dysfunction, and sarcopenia when compared with schedule II opioids. It may be useful in patients with comorbid substance use disorder or non-medical opioid use, as there is less risk of misuse, euphoria and it may improve mood. When used to treat opioid use disorder, the training and waiver was recently waived for licensed practitioners with a DEA and any provider may prescribe buprenorphine. For many reasons outlined in this article, the popularity of using buprenorphine for analgesia continues to grow and a practitioner should consider this as an excellent and safe option for chronic pain.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Pain Management

Chronic pain, including neuropathic pain, represents an untreated disease with important repercussions on the quality of life and huge costs on the national health system. It is well known that opioids are the most powerful analgesic drugs, but they represent the second or third line in neuropathic pain, that remain difficult to manage. Moreover, these drugs show several side effects that limit their use. In addition, opioids possess addictive properties that are associated with misuse and drug abuse. Among available opioids compounds, buprenorphine has been suggested advantageous for a series of clinical reasons, including the effectiveness in neuropathic pain. Some properties are partly explained by its unique pharmacological characteristics. However, questions on the dynamic profile remain to be answered. Pharmacokinetics optimization strategies, and additional potentialities, are still to be explored. In this paper, we attempt to conceptualize the potential undiscovered dynamic profile of buprenorphine.

Topics: Analgesics; Buprenorphine; Chronic Pain; Humans; Neuralgia; Quality of Life

An expert panel convened to reach a consensus on common misconceptions surrounding buprenorphine, a Schedule III partial µ-opioid receptor agonist indicated for chronic pain. The panel also provided clinical recommendations on the appropriate use of buprenorphine and conversion strategies for switching to buprenorphine from a full µ-opioid receptor agonist for chronic pain management.. The consensus panel met on March 25, 2019, to discuss relevant literature and provide recommendations on interpreting buprenorphine as a partial µ-opioid receptor agonist, prescribing buprenorphine before some Schedule II, III, or IV options, perioperative/trauma management of patients taking buprenorphine, and converting patients from a full µ-opioid receptor agonist to buprenorphine.. The panel recommended that buprenorphine's classification as a partial µ-opioid receptor agonist not be clinically translated to mean partial analgesic efficacy. The panel also recommended that buprenorphine be considered before some Schedule II, III, or IV opioids in patients with a favorable risk/benefit profile on the basis of metabolic factors, abuse potential, and tolerability and that buprenorphine be continued during the perioperative/trauma period. In addition, switching patients from a full µ-opioid receptor agonist to buprenorphine should be considered with no weaning period at starting doses that are based on the previous opioid dose.. These recommendations provide a framework for clinicians to address most clinical scenarios regarding buprenorphine use. The overall consensus of the panel was that buprenorphine is a unique Schedule III opioid with favorable pharmacologic properties and a safety profile that may be desirable for chronic pain management.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Substitution; Humans; Practice Guidelines as Topic; Receptors, Opioid, mu

The burden of chronic pain in the United States is staggering. Concurrently, the problems associated with use of opioids for treatment of chronic pain have been prominently scrutinized in recent years. Buprenorphine is an opioid that is available for treatment of both chronic pain and opioid use disorder. Its use for chronic pain has been hampered by various factors including complex and often misunderstood pharmacology, challenges to transition and induction to buprenorphine from other opioids, provider perceptions around the legality of prescribing sublingual buprenorphine for pain, and insurance coverage limitations. This article reviews the pharmacology and clinical effectiveness of buprenorphine in the context of chronic pain treatment.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders; Pain Management

The objective was to perform a systematic review and meta-analysis of the literature on the effects of buprenorphine on chronic pain outcomes (i.e., patient-reported pain intensity) in patients with and without opioid use disorder (OUD).. Ovid/Medline, PubMed, Embase, and the Cochrane Library were searched for studies that explored the effectiveness (in reducing pain) of buprenorphine treatment for chronic pain patients with and without a history of OUD. Randomized controlled trials and observational studies were included in the review.. Two separate searches were conducted to identify buprenorphine trials that included chronic pain patients either with or without OUD. Five studies used validated pain report measures and included a chronic pain population with OUD. Nine studies used validated report measures and included chronic pain patients without OUD. Meta-analysis was performed using the R, version 3.2.2, Metafor package, version 1.9-7.. The meta-analysis revealed that buprenorphine has a beneficial effect on pain intensity overall, with a small mean effect size in patients with comorbid chronic pain and OUD and a moderate- to large-sized effect in chronic pain patients without OUD.. Our results indicate that buprenorphine is modestly beneficial in reducing pain intensity in patients without OUD. Although informative, these findings should be carefully interpreted due to the small amount of data available and the variation in study designs.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders

Buprenorphine is a Schedule III opioid with unique pharmacodynamic and pharmacokinetic properties that contribute to effective analgesia and fewer safety risks than other opioids. This review article focuses on the buccal film formulation, which is preferable to other buprenorphine formulations on the basis of bioavailability, safety and efficacy. The clinical studies reviewed here confirm that buprenorphine buccal film offers effective and continuous pain relief that is generally well tolerated, with no cases of respiratory depression reported in any of the studies. On the basis of these clinical data and individual patient risk/benefit assessments, clinicians should consider utilizing buprenorphine buccal film as a first-line opioid treatment for chronic pain over other buprenorphine formulations or other opioids.

Topics: Administration, Mucosal; Analgesics, Opioid; Buprenorphine; Cheek; Chronic Pain; Humans; Mouth Mucosa; Pain Management; Receptors, Opioid, mu

Deprescribing, the process of reducing or discontinuing unnecessary or harmful medicines is an essential part of clinical practice.. To evaluate the efficacy of interventions designed to deprescribe opioid analgesics for pain relief in patients with chronic non-cancer pain.. We searched electronic databases, including clinical trial registries, from database inception to 13th January 2020 without restrictions, and conducted citation tracking. Our systematic review included randomised controlled trials (RCTs) evaluating interventions reducing the prescription, or use of opioid analgesics in patients with chronic pain versus control. Inventions could be aimed at the patient, clinician, or both. We excluded trials enrolling patients with cancer or illicit drug use. Two authors independently screened and extracted data. Outcome follow-up timepoints were short (≤ 3 months), intermediate (> 3 but < 12 months) or long (≥ 12 months) term. Primary outcome was the reduction in opioid dose [morphine milligram equivalent (MME) mg/day]. Methodological quality was assessed using the Cochrane Risk of Bias Tool.. We included ten patient-focused RCT interventions (n = 835; median 37 participants) and 2 testing clinician-focused interventions (n = 291 clinicians); none at low risk of bias. Patient-focused interventions did not reduce opioid dose in the intermediate term [e.g. dose reduction protocol, mean difference (MD) - 19.9 MME, 95% CI - 107.5 to 67.7], nor did they increase the number of participants who ceased their dose, or increase the risk of serious adverse events or adverse events. One clinician intervention of education plus decision tools versus decision tools alone reduced the number of opioid prescriptions (risk difference (RD) - 0.1, 95% CI - 0.2 to - 0.1), dose (MD - 5.3 MME, 95% CI - 6.2 to - 4.5) and use (RD - 0.1, 95% CI - 0.1 to - 0.0) in the long term.. Study heterogeneity prevented meta-analysis.. The small number of studies and heterogeneity prevented firm conclusions to recommend any one opioid-analgesic-deprescribing strategy in patients with chronic pain.. PROSPERO CRD42017068422.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Clinical Decision-Making; Deprescriptions; Drug Prescriptions; Humans; Mindfulness; Narcotic Antagonists; Opioid Epidemic; Pain Management; Randomized Controlled Trials as Topic; Treatment Outcome

Reclassification of chronic pain as a disease may be helpful because patients with chronic pain require significant treatment and rehabilitation with a clear diagnosis. This can help address critical factors including suffering, quality of life, participation, and with family and social life, which continue to become more important in evaluating the quality of the health care we give our patients today. During the past decade of the opioid epidemic, methadone was the primary treatment for opioid addiction until buprenorphine was approved. Buprenorphine's high-affinity partial agonist properties make it a good alternative to methadone due to lower abuse potential and safer adverse effect profile while maintaining significant efficacy. Expanded out-patient prescribing options have allowed physician and physician extenders such as physician assistants and nurse practitioners to treat these patients that otherwise would have been required to utilize methadone. With unique pharmacological properties, buprenorphine is a safe and effective analgesic for chronic pain. The literature for buprenorphine shows great potential for its utilization in the treatment of chronic pain.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Partial Agonism; Drug Therapy, Combination; Drug Utilization; Humans

Chronic pain is a common condition that is being increasingly recognized, diagnosed, and treated in a variety of settings. Opioids can be used to treat chronic pain but at the cost of adverse effects and risk of dependence. Recently, there has been a movement to improve analgesic care in the setting of the opioid epidemic and the overprescribing of opioids, causing over-accessibility, dependence, and large numbers of overdose deaths. Opioid-specific receptors, including the μ, δ, κ, and opioid receptor like-1 (ORL-1) receptors, are each 7-transmembrane spanning proteins, which affect the G-protein and β-arrestin cascades. Each opioid class can act differently on the receptors, resulting in full, partial, or antagonizing effects. This comprehensive review looks at different agents in major classes, nonselective and mixed/partial agonists/antagonists, including the nonselective partial agonists, levorphanol and tramadol. Mixed partial agonists/antagonists include buprenorphine, pentazocine, nalbuphine, and butorphanol. Oliceridine is the only current selective partial agonist that agonizes specific pathways to promote analgesic effects and discourage adverse effects.

Topics: Analgesics, Opioid; Animals; Buprenorphine; Chronic Pain; Drug Partial Agonism; Humans; Receptors, Opioid; Treatment Outcome

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Overdose; Humans; Methadone; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Risk Assessment; Substance Abuse Detection

Well-informed staff can help decrease risks and common misconceptions regarding opioid-tolerant patients, especially those taking methadone.. In 2015, opioid pain relievers were the second most used drug at 3.8 million. Overdose death was three times greater in 2015 than in 2000. Medication-assisted treatment was sought by more than 2 million individuals with substance use disorder, one of which is methadone. Chronic pain affects millions of adults in the USA. Opioid therapy is widely used among these adults. Related to the risk of abuse and dependence, guidelines suggest that opioid therapy may not be considered first-line treatment. A multidisciplinary approach, including thorough preoperative evaluation, the utilization of multimodal pain management strategies, and opioid-sparing techniques in both the intraoperative and postoperative periods will allow for the best possible outcome.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Methadone; Opioid-Related Disorders; Pain Management

Clinical studies demonstrate that buprenorphine is a pharmacologic agent that can be used for the treatment of various types of painful conditions. This study investigated the efficacy of 5 different types of buprenorphine formulations in the chronic pain population. The literature was reviewed on PubMed/MEDLINE, EMBASE, Cochrane Database, clinicaltrials.gov, and PROSPERO that dated from inception until June 30, 2017. Using the population, intervention, comparator, and outcomes method, 25 randomized controlled trials were reviewed involving 5 buprenorphine formulations in patients with chronic pain: intravenous buprenorphine, sublingual buprenorphine, sublingual buprenorphine/naloxone, buccal buprenorphine, and transdermal buprenorphine, with comparators consisting of opioid analgesics or placebo. Of the 25 studies reviewed, a total of 14 studies demonstrated clinically significant benefit with buprenorphine in the management of chronic pain: 1 study out of 6 sublingual and intravenous buprenorphine, the only sublingual buprenorphine/naloxone study, 2 out of 3 studies of buccal buprenorphine, and 10 out of 15 studies for transdermal buprenorphine showed significant reduction in pain against a comparator. No serious adverse effects were reported in any of the studies. We conclude that a transdermal buprenorphine formulation is an effective analgesic in patients with chronic pain, while buccal buprenorphine is also a promising formulation based on the limited number of studies.

Topics: Administration, Buccal; Administration, Cutaneous; Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Disease; Chronic Pain; Clinical Trials as Topic; Humans; Methadone; Neoplasms; Pain Management; Pain Measurement; Risk; Treatment Outcome

Rotating several different WHO level III opioid drugs is a therapeutic option for patients with chronic cancer-related pain who suffer from inadequate analgesia and/or intolerable side effects. The evidence favoring opioid rotation is controversial, and the current guidelines in Germany and other countries contain only weak recommendations for it.. This review is based on pertinent publications retrieved by a systematic review of the literature on opioid rotation for adult patients with chronic cancerrelated pain who are regularly taking WHO level III opioids by the oral or trans - dermal route.. 9 individual studies involving a total of 725 patients were included in the analysis, and 3 previous systematic reviews of studies involving a total of 2296 patients were also analyzed. Morphine, oxycodone, fentanyl, hydromorphone, and buprenorphine were used as first-line opioid drugs, and hydromorphone, bupre - norphine, tapentadol, fentanyl, morphine, oxymorphone, and methadone were used as second-line opioid drugs. In all of the studies, pain control was achieved for 14 days after each rotation. In most of them, the dose of the new drug introduced in each rotation needed to be increased above the dose initially calculated from a rotation ratio, with the exception of rotations to methadone. The frequency of side effects was only rarely lessened, but patients largely considered the result of opioid rotation to be positive. No particular opioid drug was found to be best.. Opioid rotation can improve analgesia and patient satisfaction. The success of opioid rotation appears to depend on the magnitude of the initial dose, among other factors. Tables of equianalgesic doses should be considered no more than a rough guide for determining the dose of the new drug. Rotations to methadone should be carried out under clinical supervision in experienced hands.

Topics: Analgesics, Opioid; Buprenorphine; Cancer Pain; Chronic Pain; Fentanyl; Germany; Humans; Hydromorphone; Morphine; Neoplasms; Oxycodone; Pain Management

The buprenorphine receptor binding profile is unique in that it binds to all three major opioid receptors (mu, kappa, delta), and also binds to the orphan-like receptor, the receptor for orphanin FQ/nociceptin, with lower affinity. Within the mu receptor group, buprenorphine analgesia in rodents is dependent on the recently discovered arylepoxamide receptor target in brain, which involves a truncated 6-transmembrane mu receptor gene protein, distinguishing itself from morphine and most other mu opioids. Although originally designed as an analgesic, buprenorphine has mainly been used for opioid maintenance therapy and only now is increasingly recognized as an effective analgesic with an improved therapeutic index relative to certain potent opioids. Albeit a second-, third-, or fourth-line analgesic, buprenorphine is a reasonable choice in certain clinical situations. Transdermal patches and buccal film formulations are now commercially available as analgesics. This review discusses buprenorphine pharmacodynamics and pharmacokinetics, use in certain populations, and provides a synopsis of systematic reviews and randomized analgesic trials. We briefly discuss postoperative management in patients receiving buprenorphine maintenance therapy, opioid equivalence to buprenorphine, rotations to buprenorphine from other opioids, and clinical relevance of buprenorphine-related QTc interval changes.

Topics: Administration, Sublingual; Analgesics, Opioid; Animals; Buprenorphine; Chemistry, Pharmaceutical; Chronic Pain; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug Tolerance; Humans; Narcotic Antagonists; Observational Studies as Topic; Randomized Controlled Trials as Topic; Receptors, Opioid; Substance-Related Disorders; Systematic Reviews as Topic; Transdermal Patch

The purpose of this review is to evaluate and explain our current understanding of the clinical use of buprenorphine in the treatment of chronic pain.. There has been few high-quality, unbiased studies performed on the use of buprenorphine in the treatment of chronic pain. Buprenorphine is an effective and safe analgesic that is tolerated at least as well, if not better, than other opioids. Given its safety and mechanistic advantages, the authors believe there is an important role for buprenorphine in the treatment of chronic pain severe enough to warrant the use of an opioid analgesic. Though data is lacking for superiority in chronic pain states, the other advantages of the molecule make it the preferential first-line opioid for around-the-clock pain in our practice.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans

The efficacy and safety of long-term (≥ 6 months) opioid therapy (LtOT) in chronic noncancer pain (CNCP) is under debate. A systematic review with meta-analysis of the efficacy and harms of opioids in open-label extension studies of randomized controlled trials (RCTs) has not been conducted until now.. We screened MEDLINE and clinicaltrials.gov (through to December 2013), as well as reference sections of systematic reviews of long-term RCTs of opioids in CNCP. We included open-label extension trials with a study duration ≥ 26 weeks of RCTs of ≥ 2 weeks duration. Using a random effects model, pooled estimates of event rates for categorical data and standardized mean differences (SMD) for continuous variables were calculated.. We included 11 open-label extension studies with 2445 participants with nociceptive (low back, osteoarthritis) and neuropathic (radicular, polyneuropathy) pain. Median study duration was 26 (range 26-108) weeks. Four studies tested oxycodone, two studies tramadol and buprenorphine; hydromorphone, morphine, oxymorphone and tapentadol were each tested in one study. Of the patients randomized at baseline, 28.5 % (95 % confidence interval, CI, 17.9-39.2 %) finished the open-label period; 53.5 % (95 % CI 38.1-68.2 %) of patients entering the open-label period finished the open-label period. In sum, the total loss was 71.5 % (95 % CI 60.9-83.1 %) of all patients primarily included into the RCT. A total of 4.9 % (95 % CI 2.9-8.2 %) of patients dropped out due lack of efficacy; 16.8 % (95 % CI 11.0-24.8 %) dropped out to due adverse events (AE) in the open-label period and 0.08 % (95 % CI 0.001-0.05 %) of patients died during the open-label period. Only one study systematically assessed aberrant drug behavior of the patients: 5.7 % (95 % CI 3.4-9.6 %) showed aberrant drug behavior in the opinion of the investigators and 2.6 % (95 % CI 1.2-5.8 %) were judged to show aberrant drug behavior by independent expert assessment. There was no significant change (p = 0.50) in pain intensity between the end of the randomized period and the end of open-label phase (SMD 0.19 [- 0.03, 0.41]; six studies with 1360 participants).. Only a minority of patients selected for opioid therapy at randomization finished the long-term open-label study. However, sustained effects of pain reduction could be demonstrated in these patients. LtOT can be considered in carefully selected and monitored CNCP patients who experience clinically meaningful pain reduction with at least tolerable AE in short-term opioid therapy. The English full-text version of this article is freely available at SpringerLink (under "Supplementary Material").

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Hydromorphone; Long-Term Care; Morphine; Oxycodone; Oxymorphone; Pain Measurement; Phenols; Randomized Controlled Trials as Topic; Tapentadol; Tramadol; Treatment Outcome

Buprenorphine is a lipid-soluble pharmaceutic used in the management of chronic pain. It is a partial agonist at μ-opioid receptors, an antagonist at κ-opioid receptors, an agonist at δ-opioid receptors and a partial agonist at ORL-1 (nociceptin) receptors.. An extensive literature search, including Google Scholar and Pubmed database, was conducted. Terms including and associated to 'efficacy of transdermal buprenorphine' were utilized to procure contemporary research articles in order to evaluate and compare the transdermal buprenorphine patch to commonly used traditional pain management medications.. Transdermal buprenorphine has demonstrated better efficacy than conventional pain management pharmacotherapies. Side effects were similar to those associated with other opioids and included headache, dizziness, somnolence, constipation, dry mouth, nausea, vomiting, pruritus and erythema. Similar to transdermal delivery systems used with other medication, transdermal buprenorphine was associated with application-site pruritus and application-site reactions.. Transdermal buprenorphine has significant potential for managing chronic pain. In addition to increased convenience and efficacy, advantages of transdermal buprenorphine include decreased tolerance and decreased withdrawal.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Delivery Systems; Humans; Transdermal Patch

Buprenorphine-naloxone (bup/nal in 4:1 ratio; Suboxone; Reckitt Benckiser Pharmaceuticals Incorporation, Richmond, VA) is approved by the Food and Drug Administration for outpatient office-based addiction treatment. In the past few years, bup/nal has been increasingly prescribed off-label for chronic pain management. The current data suggest that bup/nal may provide pain relief in patients with chronic pain with opioid dependence or addiction. However, the unique pharmacological profile of bup/nal confers it to be a weak analgesic that is unlikely to provide adequate pain relief for patients without opioid dependence or addiction. Possible mechanisms of pain relief by bup/nal therapy in opioid-dependent patients with chronic pain may include reversal of opioid-induced hyperalgesia and improvement in opioid tolerance and addiction. Additional studies are needed to assess the implication of bup/nal therapy in clinical anesthesia and perioperative pain management.

Topics: Ambulatory Care; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Drug Combinations; Humans; Naloxone; Opioid-Related Disorders; Pain Management; Treatment Outcome

There is growing interest in the use of sublingual buprenorphine for the treatment of chronic pain due to the unique pharmacology of buprenorphine, widespread use of the transdermal buprenorphine patch for chronic pain, and recent availability of sublingual buprenorphine tablets for the treatment of opioid dependence. The aim of this systematic review was to evaluate the evidence from clinical trials that have assessed the effectiveness of sublingual buprenorphine for chronic pain analgesia.. Electronic searches of MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane Database of Systematic Reviews were used to identify clinical trials of sublingual buprenorphine for the treatment of chronic pain.. Ten trials involving 1,190 patients were included in the review. Due to heterogeneity of studies, pooling of the results and meta-analysis were not possible. All studies reported that sublingual buprenorphine demonstrated some effectiveness as a chronic pain analgesic. The majority of studies were observational and of low quality.. Preliminary trials suggest a plausible role; however, due to a paucity of high-quality trials, the current evidence is insufficient to determine the effectiveness of sublingual buprenorphine for the treatment of chronic pain. Rigorous further trials are warranted.

Topics: Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Chronic Pain; Clinical Trials as Topic; Humans

Opioid painkiller dependence is a growing problem and best-practice management is not well defined. We report a case of a young woman exhibiting dependence on codeine, originally prescribed for myalgic encephalopathy, after escalating use over a 10-year period. In 2012, a consultation with a new general practitioner, who had extensive experience of patients with substance abuse, revealed the underlying dependence. After building trust for 6 months, she was able to admit to medication abuse, and was referred to the community drug and alcohol team. On presentation to the team, the patient had no pain issues and the dihydrocodeine use--600 tablets/week--solely reflected her dependence. The patient successfully underwent rapid induction with buprenorphine/naloxone as opioid substitution treatment over 2 days. She is currently stable, engaged with recovery support services and psychosocial counselling, and has just returned to work. She is maintained on a therapeutic dose of buprenorphine 10 mg/naloxone 2.5 mg.

Topics: Acetaminophen; Analgesics, Opioid; Buprenorphine; Chronic Pain; Codeine; Counseling; Fatigue Syndrome, Chronic; Female; Follow-Up Studies; Humans; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Primary Health Care; Risk Assessment; Severity of Illness Index; Treatment Outcome; Young Adult

Chronic pain in the elderly is common. Especially in the elderly inadequate treatment of pain can cause significant functional impairmentand deterioration of qualityof life.. Theaim of this post-marketing surveillance study was to collect data from clinical practice on the analgesic efficacy and safety of the 7-day transdermal buprenorphine patch in patients with chronic non-malignant pain pre-treated with opioids. A total of 2713 elderly multimorbid patients were switched to 7-day transdermal buprenorphine patch from previous opioid treatment mainly due to inadequate analgesia. 83% of patients received a 7-day transdermal buprenorphine patch dosage > or = 10 microg/h. During the 8-weekobservation period, data on pain intensity, quality of sleep/life (NRS-11 point scales) and safety wererecorded.. Mean pain intensity decreased by 4 points with 7-day transdermal buprenorphine patch (p < or = 0.001). Quality of sleep and life as well as social activities and self-reliance improved significantly. Compliance and tolerability were assessed as very good/good in > 90% of patients. Adverse drug reactions (ADRs) occurred in 3% of patients and corresponded to 90.1% to the already-known spectrum of ADRs of 7-daytransdermal buprenorphinepatch.. The results confirm that elderly patients with opioid pre-treatment benefit from a switch to 7-day transdermal buprenorphine patch with regard to reduction of pain and improved quality of life.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Substitution; Drug Therapy, Combination; Follow-Up Studies; Germany; Humans; Pain Measurement; Patient Satisfaction; Prospective Studies; Quality of Life

Preoperative evaluation of patients with chronic pain is important because it may lead to multidisciplinary preoperative treatment of patients' pain and a multimodal analgesia plan for effective pain control. Preoperative multidisciplinary management of chronic pain and comorbid conditions, such as depression, anxiety, deconditioning, and opioid tolerance, can improve patient satisfaction and surgical recovery. Multimodal analgesia using pharmacologic and nonpharmacologic strategies shifts the burden of analgesia away from simply increasing opioid dosing. In more complicated chronic pain patients, multidisciplinary treatment, including pain psychology, physical therapy, judicious medication management, and minimally invasive interventions by pain specialists, can improve patients' satisfaction and surgical outcome.

Topics: Analgesia; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders; Pain Measurement; Pain, Postoperative; Perioperative Period; Preoperative Care

Increasingly, patients with unhealthy alcohol and other drug use are being seen in primary care and other non-specialty addiction settings. Primary care providers are well positioned to screen, assess, and treat patients with alcohol and other drug use because this use, and substance use disorders, may contribute to a host of medical and mental health harms. We sought to identify and examine important recent advances in addiction medicine in the medical literature that have implications for the care of patients in primary care or other generalist settings. To accomplish this aim, we selected articles in the field of addiction medicine, critically appraised and summarized the manuscripts, and highlighted their implications for generalist practice. During an initial review, we identified articles through an electronic Medline search (limited to human studies and in English) using search terms for alcohol and other drugs of abuse published from January 2010 to January 2012. After this initial review, we searched for other literature in web-based or journal resources for potential articles of interest. From the list of articles identified in these initial reviews, each of the six authors independently selected articles for more intensive review and identified the ones they found to have a potential impact on generalist practice. The identified articles were then ranked by the number of authors who selected each article. Through a consensus process over 4 meetings, the authors reached agreement on the articles with implications for practice for generalist clinicians that warranted inclusion for discussion. The authors then grouped the articles into five categories: 1) screening and brief interventions in outpatient settings, 2) identification and management of substance use among inpatients, 3) medical complications of substance use, 4) use of pharmacotherapy for addiction treatment in primary care and its complications, and 5) integration of addiction treatment and medical care. The authors discuss each selected articles' merits, limitations, conclusions, and implication to advancing addiction screening, assessment, and treatment of addiction in generalist physician practice environments.

Topics: Adrenergic beta-Antagonists; Alcoholism; Analgesics, Opioid; Behavior, Addictive; Buprenorphine; Cardiovascular Diseases; Chronic Pain; Humans; Mass Screening; Narcotic Antagonists; Primary Health Care; Risk Factors; Substance-Related Disorders

Buprenorphine lower-dose (5, 10 and 20 μg/h) transdermal patches, which are administered once every 7 days, are indicated in the management of chronic non-malignant pain. This review focuses on the labelling of this formulation (BuTrans®) in the EU. The analgesic efficacy of transdermal buprenorphine in patients with osteoarthritis of the hip and/or knee has been demonstrated to be equivalent to sublingual buprenorphine, noninferior to prolonged-release tramadol and generally superior to a matching transdermal placebo patch. When used together with regularly scheduled oral paracetamol (acetaminophen), transdermal buprenorphine was noninferior to codeine plus paracetamol. Transdermal buprenorphine has also shown analgesic efficacy in patients with chronic non-malignant pain of various causes.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Labeling; European Union; Humans; Transdermal Patch

To systematically assess efficacy and safety of buprenorphine patch versus fentanyl patch in patients with chronic moderate to severe pain.. Fifteen databases were searched up to December 2010. Randomised and quasi-randomised trials assessing the efficacy in patients with chronic pain were included. Quantitative methods for data synthesis were used and two network meta-analyses were conducted.. Fourteen unique trials (17 publications) were included. No head-to-head randomised trials of buprenorphine patch compared with fentanyl patch were identified. Therefore, less robust evidence from indirect comparisons was used. Results from a network meta-analysis of non-enriched designs (eight trials), using trials versus placebo and trials versus morphine for indirect comparisons, indicated that transdermal fentanyl, in comparison with transdermal buprenorphine, showed significantly more nausea (odds ratio [OR] 4.66, 95% confidence interval (CI) 1.07 to 20.39), a significantly higher number of treatment discontinuations due to adverse events (OR 5.94, 95% CI 1.78 to 19.87), and non-significant differences on all other outcomes, including pain measures. In comparison with morphine, transdermal buprenorphine had a significantly higher decrease of pain intensity (MD [mean difference] -16.20, 95% CI -28.92 to -3.48) while morphine caused more cases of constipation (OR 7.50, 95% CI 1.45 to 38.85) and a significantly higher number of treatment discontinuations due to adverse events (OR 5.80, 95% CI 1.68 to 20.11). All other outcomes showed non-significant differences between transdermal buprenorphine and morphine. The results were similar when also including six trials using enriched designs with the exception of more cases of vomiting for fentanyl (OR 17.32, 95% CI 4.43 to 67.71) and morphine (OR 15.85, 95% CI 3.92 to 64.13) compared to buprenorphine.. The findings indicate comparability of transdermal buprenorphine and transdermal fentanyl for pain measures with significantly fewer adverse events (nausea and treatment discontinuation due to adverse events) caused by transdermal buprenorphine.

Topics: Administration, Oral; Analgesics, Opioid; Buprenorphine; Chronic Pain; Constipation; Fentanyl; Humans; Morphine; Nausea; Pain; Pain Measurement; Transdermal Patch; Treatment Outcome

Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment.. A multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms.. This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD.. ClinicalTrials.gov Identifier: NCT04648228.

Topics: Acceptance and Commitment Therapy; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Middle Aged; Opioid-Related Disorders; Veterans; Young Adult

Despite high co-occurrence, chronic pain is often unaddressed in treatment for opioid use disorder (OUD) and little is known about mechanisms that may underlie associations between pain and opioid use. Using an attentional bias (AB) task with both pain and opioid cues, we evaluated a cognitive bias modification (CBM) task administered during regularly scheduled medications for OUD (mOUD) dosing visits. The current study evaluated the feasibility, acceptability, and preliminary efficacy of the CBM task. Outcomes for AB tasks used traditional mean-based score and trial-level bias scores (TLBS).. In a double-blind, randomized controlled trial, 28 individuals with OUD and chronic pain engaged in mOUD were randomized to either CBM or an AB control condition and completed up to three tasks per week for four weeks. Standard AB task was completed at baseline and post-treatment. Participants completed feasibility and acceptability measures, and preliminary efficacy (i.e., change in AB) was assessed using ANOVA models.. Participants attended 83.3% of scheduled sessions and generally reported the task was enjoyable, credible, and easy to complete. Preliminary results demonstrated a condition by time interaction highlighting a reduction in AB in the CBM group but not the control group in opioid TLBS variability (F[1,26]=5.01, p = .034) and pain TLBS towards (F[1,26]=6.42, p = .018) and pain TLBS variability (F[1,26]=5.24, p = .03).. The current study supports integrating brief, computer-based tasks designed to reduce AB into mOUD clinical care. The preliminary results suggest that TLBS outcomes may be more sensitive to capture changes in AB; however, larger studies are required.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Cognition; Cues; Feasibility Studies; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders

Opioids are effective in pain-management, but long-term opioid users can develop prescription opioid use disorder (OUD). One treatment strategy in patients with OUD is rotating from a short-acting opioid to a long-acting opioid (buprenorphine/naloxone (BuNa) or methadone). Both BuNa and methadone have been shown to be effective strategies in patients with OUD reducing opioid misuse, however data on head-to-head comparison in patients with chronic non-malignant pain and prescription OUD are limited.. This two-armed open-label, randomized controlled trial aims to compare effectiveness between BuNa and methadone in patients with chronic non-malignant with prescription OUD (n = 100). Participants receive inpatient rotation to either BuNa or methadone with a flexible dosing regimen. The primary outcome is opioid misuse 2 months after rotation. Secondary outcomes include treatment compliance, side effects, analgesia, opioid craving, quality of life, mood symptoms, cognitive and physical functioning over 2- and 6 months follow-up. Linear mixed model analysis will be used to evaluate change in outcome parameters over time between the treatment arms.. This is one of the first studies comparing buprenorphine/naloxone and methadone for treating prescription OUD in a broad patient group with chronic non-malignant pain. Results may guide future treatment for patients with chronic pain and prescription OUD. Trial registration https://www.trialregister.nl/ , NL9781.

Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Prescriptions; Quality of Life; Randomized Controlled Trials as Topic

The aim of the study was to evaluate analgesia, adverse effects, and quality of life of elderly patients diagnosed with osteoarthritis during treatment with different initial doses of transdermal buprenorphine. Transdermal buprenorphine was used for 10 days in 60 patients over 64 years old with chronic pain of severe intensity - Numerical Rating Scale (NRS > 5) caused by degenerative changes in joints. All patients were randomly assigned to 3 groups. A starting dose for the treatment was respectively: 8.75 μg/h, 17.5 μg/h or 35 μg/h, in each group. The severity and impact of pain on everyday activities performed by the patients were assessed at baseline and daily for 10 days using the Brief Pain Inventory - Short Form. In order to identify the components of neuropathic pain, except for the symptoms (hyperalgesia and allodynia), the DN4 (Douleur Neuropathique en 4 questionnaire) was used. During buprenorphine treatment a decrease in pain severity was obtained in all groups of patients as well as an improvement in pain interference with general activity, mood, walking ability, relations with other people, sleep and enjoyment of life with no differences between patient groups treated with different initial doses of transdermal buprenorphine. No differences regarding DN4 scores were find between patient groups. Several adverse effects (drowsiness, confusion, vomiting) occurred less frequently in groups of patients treated with lower initial doses (8.75 μg/h and 17.5 μg/h) in comparison to a starting dose of 35 μg/h. We concluded that treatment of elderly patients with chronic pain of severe intensity with transdermal buprenorphine provided effective analgesia and improvement of quality of life with respect to general functioning of patients. Treatment tolerance seemed to be better with lower initial doses of transdermal buprenorphine: 8.75 μg/h and 17.5 μg/h in comparison with the dose of 35 μg/h.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Chronic Pain; Female; Humans; Male; Osteoarthritis; Quality of Life

The purpose of this project was to assess the feasibility and acceptability of a hatha yoga program designed to target chronic pain in people receiving opioid agonist therapy for opioid use disorder. We conducted a pilot randomized trial in which people with chronic pain who were receiving either methadone maintenance therapy (n = 20) or buprenorphine (n = 20) were randomly assigned to weekly hatha yoga or health education (HE) classes for 3 months. We demonstrated feasibility in many domains, including recruitment of participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals. Fifty percent of participants in yoga (95% CI: 0.28-0.72) and 65% of participants in HE (95% CI: 0.44-0.87) attended at least 6 of 12 possible classes (p = 0.62). Sixty-one percent in the yoga group reported practicing yoga at home, with a mean number of times practicing per week of 2.67 (SD = 2.37). Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05). In conclusion, yoga can be delivered on-site at opioid agonist treatment programs with home practice taken up by the majority of participants. Future research may explore ways of increasing the yoga "dosage" received. This may involve testing strategies for increasing either class attendance or the amount of home practice or both.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Feasibility Studies; Female; Health Education; Humans; Male; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Pilot Projects; Yoga

Chronic pain and depression often co-occur, and pain may exacerbate depression in people with dementia.. The objective of this study was to assess the efficacy and safety of analgesic treatment for depression in nursing home patients with advanced dementia and clinically significant depressive symptoms.. We conducted a multicentre, parallel-group, double-blind, placebo-controlled trial in 47 nursing homes, including 162 nursing home patients aged ≥ 60 years with dementia (Mini-Mental State Examination ≤ 20) and depression (Cornell Scale for Depression in Dementia ≥ 8). Patients were randomised to receive active analgesic treatment (paracetamol or buprenorphine transdermal system) or identical placebo for 13 weeks. The main outcome measure was the change in depression (Cornell Scale for Depression in Dementia) from baseline to 13 weeks, assessed using linear mixed models with fixed effects for time, intervention and their interaction in the models. Secondary outcomes were to assess whether any change in depression was secondary to change in pain (Mobilisation-Observation-Behaviour-Intensity-Dementia-2 Pain Scale) and adverse events.. The mean depression change was - 0.66 (95% confidence interval - 2.27 to 0.94) in the active group (n = 80) and - 3.30 (- 4.68 to -1.92) in the placebo group (n = 82). The estimated treatment effect was 2.64 (0.55-4.72, p = 0.013), indicating that analgesic treatment had no effect on depressive symptoms from baseline to 13 weeks while placebo appeared to ameliorate depressive symptoms. There was no significant reduction in pain in the active treatment group (paracetamol and buprenorphine combined) vs. placebo; however, a subgroup analysis demonstrated a significant reduction in pain for paracetamol vs. placebo [by - 1.11 (- 2.16 to - 0.06, p = 0.037)] from week 6 to 13 without a change in depression. Buprenorphine did not have significant effects on depression [3.04 (- 0.11 to 6.19), p = 0.059] or pain [0.47 (- 0.77 to 1.71), p = 0.456] from 0 to 13 weeks. Thirty-five patients were withdrawn from the study because of adverse reactions, deterioration or death: 25 (31.3%) during active treatment [23 (52.3%) who received buprenorphine], and ten (12.2%) in the placebo group. The most frequently occurring adverse events were psychiatric (17 adverse reactions) and neurological (14 adverse reactions).. Analgesic treatment did not reduce depression while placebo appeared to improve depressive symptoms significantly by comparison, possibly owing to the adverse effects of active buprenorphine. The risk of adverse events warrants caution when prescribing buprenorphine for people with advanced dementia.. ClinicalTrials.gov NCT02267057 (registered 7 July, 2014) and Norwegian Medicines Agency EudraCT 2013-002226-23.

Topics: Acetaminophen; Administration, Cutaneous; Aged, 80 and over; Analgesics; Buprenorphine; Chronic Pain; Dementia; Depression; Double-Blind Method; Female; Humans; Male; Nursing Homes; Treatment Outcome

We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain.. This was an open-label study conducted in Hong Kong, Korea, and the Philippines between June 2013 and April 2015. Eligible patients fulfilled the following criteria: 18 to 80 years of age; clinical diagnosis of osteoarthritis, rheumatoid arthritis, low back pain, or joint/muscle pain; chronic non-malignant pain of moderate to severe intensity (Box-Scale-11 [BS-11] pain score ≥ 4), not adequately controlled with non-opioid analgesics and requiring an opioid for adequate analgesia; and no prior history of opioid treatment. Patients started with a 5 μg/h buprenorphine patch and were titrated as necessary to a maximum of 40 μg/h over a 6-week period to achieve optimal pain control. Patients continued treatment with the titrated dose for 11 weeks. The primary efficacy endpoint was the change in BS-11 pain scores. Other endpoints included patients' sleep quality and quality of life as assessed by the 8-item Global Sleep Quality Assessment Scale (GSQA) questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire-3 Level version (EQ-5D-3 L), respectively. Tolerability was assessed by collecting adverse events.. A total of 114 eligible patients were included in the analysis. The mean BS-11 score at baseline was 6.2 (SD 1.6). Following initiation of TDB, there was a statistically significant improvement in BS-11 score from baseline to visit 3 (least squares [LS] mean change: -2.27 [95% CI -2.66 to -1.87]), which was maintained till the end of the study (visit 7) (LS mean change: -2.64 [95% -3.05 to -2.23]) (p < 0.0001 for both). The proportion of patients who rated sleep quality as 'good' increased from 14.0% at baseline to 26.9% at visit 6. By visit 6, the mean EQ VAS score increased by 7.7 units (SD 17.9). There were also significant improvements in patients' levels of functioning for all EQ-5D-3 L dimensions from baseline at visit 6 (p < 0.05 for all). Seventy-eight percent of patients reported TEAEs and 22.8% of patients discontinued due to TEAEs. TEAEs were generally mild to moderate in intensity (96.5%).. TDB provides effective pain relief with an acceptable tolerability profile over the 11-week treatment period in Asian patients with chronic musculoskeletal pain. More studies are needed to examine the long-term efficacy and safety of TBD treatment in this patient population.. ClinicalTrials.gov NCT01961271 . Registered 7 October 2013 (retrospectively registered; first patient was enrolled on 28 June 2013 and last patient last visit date was 26 Apr 2015).

Topics: Administration, Cutaneous; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Hong Kong; Humans; Male; Middle Aged; Musculoskeletal Pain; Pain Management; Pain Measurement; Philippines; Prospective Studies; Quality of Life; Republic of Korea; Surveys and Questionnaires; Transdermal Patch; Treatment Outcome

Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA(®)) delivery technology. Buccal buprenorphine (BBUP; Belbuca(TM), Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients.. Patients (n = 749) were titrated to a dose of BBUP (range, 150-450 µg every 12 h) that was generally well tolerated and provided adequate analgesia for ≥14 days, and then randomized to BBUP (n = 229) or placebo (n = 232), respectively. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in the mean of daily average pain intensity scores (numeric rating scale from 0 [no pain] to 10 [worst pain imaginable]).. Patients were experiencing moderate to severe pain at study entry: mean (SD) = 7.15 (1.05). Following titration, pain was reduced to the mild range; 2.81 (1.07). After randomization, mean (SD) pain scores increased from baseline to week 12 more with placebo (1.59 [2.04]) versus BBUP: (0.94 [1.85]) with a significant between-group difference (-0.67 [95% CI: -1.07 to -0.26]; p = 0.0012). A significantly larger percentage of patients receiving BBUP versus placebo had ≥30% pain reduction (63% vs 47%; p = 0.0012). During double-blind treatment, the most frequent adverse events (AEs) with BBUP were nausea (10%), constipation (4%) and vomiting (4%). The most common AEs with placebo were nausea (7%), upper respiratory tract infection (4%), headache (3%) and diarrhea (3%).. These findings demonstrate the efficacy and tolerability of BBUP among opioid-naive patients requiring around-the-clock opioid treatment for CLBP.

Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Double-Blind Method; Female; Follow-Up Studies; Humans; Low Back Pain; Male; Middle Aged; Pain Measurement; Severity of Illness Index; Treatment Outcome

A buccal film of buprenorphine (BBUP) was evaluated for safety and efficacy in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-experienced patients (30 to ≤160 mg/d morphine sulfate equivalent) with moderate to severe chronic low back pain taking around-the-clock opioid analgesics. Patients' opioid doses were tapered to ≤30 mg morphine sulfate equivalent before open-label titration with BBUP (range, 150-900 μg every 12 hours). Patients who responded (received adequate analgesia that was generally well tolerated for 14 days) were randomized to receive buprenorphine (n = 254) or placebo (n = 257) buccal film. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in mean average daily pain-intensity scores using a rating scale of 0 (no pain) to 10 (worst pain imaginable). In the intent-to-treat population, mean pain scores were 6.7 after opioid taper and declined to 2.8 after the BBUP titration period. After randomization, mean pain scores were lower in the BBUP group than in the placebo group; the difference between groups in the mean change from baseline to week 12 was -0.98 (95% CI, -1.32 to -0.64; P < 0.001). A significantly larger percentage of patients receiving BBUP than placebo had pain reductions ≥30% and ≥50% (P < 0.001 for both). In the double-blind portion of the study, the only adverse event reported more frequently with BBUP than placebo and in ≥5% of patients was vomiting (5.5% vs 2.3%). These findings demonstrate the efficacy and tolerability of BBUP in opioid-experienced patients taking around-the-clock opioid treatment for chronic low back pain.

Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Buprenorphine; Chronic Pain; Disability Evaluation; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Low Back Pain; Male; Middle Aged; Morphine; Narcotics; Pain Measurement; Severity of Illness Index

This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP).. A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale.. Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences).. Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Pain Measurement; Transdermal Patch; Treatment Outcome

This open-label, phase 3b study evaluated the effectiveness and tolerability of oral tapentadol prolonged release (PR; 50-250 mg twice daily [b.i.d.]) for managing severe, chronic low back pain in patients responding to World Health Organization (WHO) step III opioids but tolerating treatment poorly. Equianalgesic ratios for tapentadol to prior strong opioids were calculated.. Patients rotated directly from prior WHO step III opioids to tapentadol. Patients received tapentadol PR (50-250 mg b.i.d.) during 5-week titration and 7-week maintenance periods. Tapentadol immediate release (IR) 50 mg (≤ twice/day, ≥ 4 h apart) was allowed (total daily dose of tapentadol PR and IR ≤ 500 mg/day). The primary endpoint was responder rate 1 at week 6 (percentage of patients with the same or less pain intensity [11-point numerical rating scale (NRS; 3-day average)] vs week -1).. Responder rate 1 at week 6 (last observation carried forward [LOCF]) was 80.9% (76/94; P < 0.0001 vs. the null responder hypothesis rate [<60%]), resulting in a positive trial despite premature termination (136 recruited of 180 planned). Significant improvements from baseline in pain intensity and neuropathic pain symptoms were observed at weeks 6 and 12 with tapentadol PR (P < 0.05). Equianalgesic ratios were calculated for PR formulations alone and for PR and IR formulations combined for tapentadol to oxycodone, buprenorphine, fentanyl, morphine, and hydromorphone. The prevalences of adverse events reported as the reason for switching to tapentadol (most commonly constipation and nausea) decreased over time.. Tapentadol PR (50-250 mg b.i.d.) provided at least comparable pain relief and improved tolerability versus prior strong opioids in patients with severe, chronic low back pain responding to WHO step III therapy. Conversion from strong opioids to tapentadol PR, with its two mechanisms of action, went smoothly considering overall effectiveness and tolerability outcomes. Equianalgesic ratios of tapentadol to oxycodone and other strong opioids were in line with other phase 3/3b studies.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Constipation; Delayed-Action Preparations; Female; Fentanyl; Humans; Hydromorphone; Low Back Pain; Male; Middle Aged; Morphine; Neuralgia; Oxycodone; Pain Measurement; Phenols; Severity of Illness Index; Tapentadol

Patients with opioid addiction who receive prescription opioids for treatment of nonmalignant chronic pain present a therapeutic challenge. Fifty-four participants with chronic pain and opioid addiction were randomized to receive methadone or buprenorphine/naloxone. At the 6-month follow-up examination, 26 (48.1%) participants who remained in the study noted a 12.75% reduction in pain (P = 0.043), and no participants in the methadone group compared to 5 in the buprenorphine group reported illicit opioid use (P = 0.039). Other differences between the two conditions were not found. Long-term, low-dose methadone or buprenorphine/naloxone treatment produced analgesia in participants with chronic pain and opioid addiction.

Topics: Administration, Sublingual; Analgesics, Opioid; Analysis of Variance; Buprenorphine; Chronic Pain; Drug Combinations; Female; Humans; Male; Methadone; Middle Aged; Naloxone; Opioid-Related Disorders; Prescription Drug Misuse; Severity of Illness Index; Substance Abuse Detection; Treatment Outcome

Chronic pain in the elderly is common. Especially in the elderly inadequate treatment of pain can cause significant functional impairmentand deterioration of qualityof life.. Theaim of this post-marketing surveillance study was to collect data from clinical practice on the analgesic efficacy and safety of the 7-day transdermal buprenorphine patch in patients with chronic non-malignant pain pre-treated with opioids. A total of 2713 elderly multimorbid patients were switched to 7-day transdermal buprenorphine patch from previous opioid treatment mainly due to inadequate analgesia. 83% of patients received a 7-day transdermal buprenorphine patch dosage > or = 10 microg/h. During the 8-weekobservation period, data on pain intensity, quality of sleep/life (NRS-11 point scales) and safety wererecorded.. Mean pain intensity decreased by 4 points with 7-day transdermal buprenorphine patch (p < or = 0.001). Quality of sleep and life as well as social activities and self-reliance improved significantly. Compliance and tolerability were assessed as very good/good in > 90% of patients. Adverse drug reactions (ADRs) occurred in 3% of patients and corresponded to 90.1% to the already-known spectrum of ADRs of 7-daytransdermal buprenorphinepatch.. The results confirm that elderly patients with opioid pre-treatment benefit from a switch to 7-day transdermal buprenorphine patch with regard to reduction of pain and improved quality of life.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Substitution; Drug Therapy, Combination; Follow-Up Studies; Germany; Humans; Pain Measurement; Patient Satisfaction; Prospective Studies; Quality of Life

Buprenorphine and fentanyl transdermal patches are used widely for the management of persistent malignant and nonmalignant pain. Buprenorphine and fentanyl transdermal patches, both potent opioids, are considered to be equally efficacious in managing persistent pain. Various retrospective studies comparing dosage changes of buprenorphine and fentanyl patches in persistent pain patients have been completed; however, no long-term prospective, randomized, clinical study has compared the effectiveness of these patches. The objective of the present study was to satisfy this need.. This study aims to compare prospectively the long-term efficacy, acceptability, and side effects of both of these patches in patients with persistent pain. This study would examine the feasibility and lay the groundwork for a larger, multicenter study where such efficacy and safety outcomes of the two medications can be adequately assessed.. The participants were 46 adults (range 22-80 years.) with nonmalignant persistent pain (mean = 11 years), predominantly with lower back pain. Data were obtained monthly for 12 months. Participants recruited were opioid-naïve patients, having pain for the greater part of the day and night, and appropriate for treatment with transdermal patches. After initial assessment, participants were randomly allocated to either buprenorphine or fentanyl patch treatment. Participants were then titrated to optimal doses of medication. Patients with adverse effects or unsatisfactory pain relief were treated alternatively and discontinued from the study.. Nearly one-third of all patients, 41% (8 of 22) of the transdermal buprenorphine (TDB) group and 37.5% (8 of 24) of the transdermal fentanyl (TDF) group stopped treatment due to unacceptable side effects or inadequate pain relief. The remaining participants showed a similar trend in the improvement of pain intensity, physical activity, sleep, and mood throughout the study. Significant relief in the intensity of pain was achieved for the initial 6 months and the effects stabilized in the remainder of the study in both groups. There were no significant group differences over time. However, a higher equipotent dose of fentanyl was required for comparable pain relief. Compared with TDF group, the TDB group initially experienced relatively less side effects. However, a greater number of buprenorphine users suffered from local skin reactions. Buprenorphine users had significant improvement in mood. Thirty-one percent (5 of 16) of the buprenorphine group and 57% (8 of 14) of the fentanyl users needed additional pain relief medications by the end of 3 months. By the end of 12 months, a significant number 78% (7 of 9) of buprenorphine users but comparatively fewer 44% (4 of 9) of the fentanyl group used rescue medicines. Both had more doctor visits in the latter half of the study.. Thirty percent of the total number of patients discontinued treatment because of side effects or unsatisfactory pain relief. For those continuing treatment, clinical improvements were seen in the initial 6 months in both groups. Fifty percent of the TDB and 43% of TDF groups had significant relief in 3 months, which persisted up to 6 months. Only 11% and 13% of patients, respectively, had sustained relief after 6 months. Twenty percent more patients in the TDB group benefited significantly in symptoms of depression from TDB compared with the TDF group. Interestingly, switching of patches seemed to increase acceptability by preventing adverse effects and tolerance. Confirmation of these effects should be studied in future with a multicenter study and larger sample.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Feasibility Studies; Female; Fentanyl; Humans; Longitudinal Studies; Male; Neoplasms; Pain Measurement; Prospective Studies; Transdermal Patch; Treatment Outcome

To evaluate the impact of 12 weeks of treatment with Butrans® (buprenorphine) transdermal system (BTDS) on the health-related quality of life (HRQoL) for patients with chronic low back pain (CLBP), and the maintenance of effects over 52 weeks.. A multicenter, enriched, double-blind (DB), randomized trial comparing BTDS 20 μg/h (BTDS 20) against 5 μg/h (BTDS 5) for treatment of opioid-experienced patients with moderate-to-severe CLBP, including a 52-week open-label (OL) extension phase.. QoL was measured with the SF-36v2 survey before and after an OL run-in period with BTDS 20, three times during the DB phase, and seven times over the extension phase. This post hoc analysis tested for SF-36v2 score differences between treatment groups during the DB phase and maintenance of effects over the extension phase.. At 12 weeks, BTDS 20 produced larger improvements than BTDS 5 in role limitations due to physical health, bodily pain and overall physical QoL (p < 0.01). Treatment group differences in overall physical QoL were sustained throughout the DB phase. Quality-of-life improvements associated with BTDS 20 persisted through the extension phase.. These data suggest that opioid-experienced moderate-to-severe CLBP patients receiving BTDS 20 exhibited better QoL than patients receiving BTDS 5.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Quality of Life; Severity of Illness Index; Transdermal Patch; Treatment Outcome

Opioids are the most effective pain medication available, yet concerns about their safety may limit their administration to those in need. In efforts to identify analgesics with lower potential for abuse and dependence, recent evidence suggests that combinations of opioids with ultra-low doses of the opioid antagonist naloxone may enhance the analgesic effect with increased safety. This study investigated the use of buprenorphine (0.3 mg) plus ultra-low-dose naloxone (0.02 mg) (BUP + ULDN) as compared with buprenorphine alone (0.3 mg) (BUP) for the treatment of pain.. In a double-blind, placebo-controlled, randomized cross-over design, 12 study participants with lingering, noncancer pain received each medication intravenously for 5 days of dosing, separated by an intertrial interval of at least 7 days to avoid possible carryover effects.. We found no order effects and no differences between medications in pre- to postdose pain ratings, side effects, or adverse events.. These findings suggest that BUP + ULDN is not more effective in reducing pain than BUP.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Female; Humans; Male; Pain Measurement

To assess patients' perceptions regarding the low-dose 7-day buprenorphine transdermal patch for treatment of moderate non-malignant chronic pain.. Patient-reported outcome data were collected in clinical practices in Germany in a prospective, multicenter, non-interventional observation using the German Pain Questionnaire/German Pain Diary. Questionnaires were completed by the patients without influence from the attending physician. Mean change in pain intensity (lowest, average, and highest pain intensity in the previous 24 h), changes in Hospital Anxiety and Depression Scale scores (HADS-A and HADS-D), in impairments of daily activities (modified pain disability index, mPDI), in quality of life (quality of life impairment by pain inventory, QLIP), and in overall burden of pain over a 12-week treatment period were evaluated.. Data of 891 patients were assessed (mean age 72.8 years). Buprenorphine starting doses were mainly 5 µg/h (67.1% of patients) and 10 µg/h (27.3%). At the end of week 12, the majority received either 5 µg/h (41%) or 10 µg/h (42.3%) buprenorphine. Mean average pain intensity was reduced by 5.1 points to 1.7 ± 1.3 from 6.8 ± 1.5 points at baseline (76% improvement). Amelioration was observed in HADS-A (59% from 7.8 ± 3.3 at baseline) and HADS-D (56% from 9.2 ± 3.1), in mPDI sum score (76%; from 31.1 ± 9.8), and in quality of life (165%; from 13.9 ± 10.1). Mean burden of pain continuously decreased.. All those inherent in open-label observations and pain studies using subjective and patient-reported outcome parameters (such as the lack of a control group).. Our results indicate that the 7-day buprenorphine patch might be considered an effective treatment option for moderate non-malignant chronic pain management in daily clinical practice. The mostly elderly patient population of this patient survey experienced sustained pain relief and improvements in pain-related impairments of daily activities and quality of life, leading to a substantial reduction in overall burden of pain.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Follow-Up Studies; Germany; Humans; Male; Pain Management; Patient Satisfaction; Surveys and Questionnaires

In this enriched design study, 1,160 opioid-experienced patients with chronic, moderate to severe low back pain entered an open-label run-in period; 660 demonstrated analgesic benefit from and tolerability to buprenorphine transdermal system 20 mcg/hour (BTDS 20) treatment and were randomized to receive either BTDS 20, BTDS 5 mcg/hour (BTDS 5), or the active control (immediate release oxycodone 40-mg/day) during an 84-day double-blind phase. The primary endpoint, "average pain in the last 24 hours" during double-blind weeks 4, 8, and 12, was significantly lower for patients receiving BTDS 20 compared with patients receiving BTDS 5 (P < .001, treatment difference of -.67). A treatment difference of -.75 in favor of oxycodone 40 mg/day versus BTDS 5 (P < .001) indicated the assay sensitivity of the study. Four sensitivity analyses, secondary, and exploratory analyses supported the results of the primary analysis. Incidences of treatment-emergent adverse events were 56% during the open-label period, and 59, 77, and 73% for the BTDS 5, BTDS 20, and oxycodone 40 mg/day treatment groups, respectively, during the double-blind phase. One death considered unrelated to study treatment occurred in a patient receiving BTDS 10 during the run-in period. BTDS 20 treatment was demonstrated to be efficacious and generally well tolerated.. This article presents results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine (BTDS). In this active controlled, superiority study with an enriched design, BTDS 20 was found to be efficacious and generally well tolerated.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Pain; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Oxycodone; Transdermal Patch; Treatment Outcome

Buprenorphine is a partial mu opioid agonist that has been increasingly utilized to treat patients with chronic pain and opioid use disorder (OUD). The drug has proven to provide significant chronic pain relief at low doses ranging from 75 to 1800 mcg. The conventional buprenorphine transitional process delays its introduction until patients begin withdrawal. However, this process can pose a barrier to both patients and providers due to some patients' inability to tolerate traditional prerequisite withdrawal. To our knowledge, this is a rare reported case to describe a transitional process utilizing buccal buprenorphine in which a patient with chronic pain simultaneously tapered completely off an extended-release (ER) full opioid agonist and uptitrated buprenorphine. The patient was weaned from oxycodone ER 30 mg every 12 h and oxycodone/acetaminophen 10/325 mg 3x/day for breakthrough pain utilizing an unconventional approach. Tapering down to oxycodone ER 20 mg 2x/day for the first 2 weeks was successful. However, reducing to oxycodone ER 10 mg 2x/day for the following 2 weeks presented adherence difficulty and increased breakthrough pain. At this time, buccal buprenorphine was added at 300 mcg daily for 3 days. From days 4 to 6, buprenorphine was increased to 300 mcg 2x/day and oxycodone ER decreased to 10 mg daily. Six days later, oxycodone ER was discontinued and oxycodone/acetaminophen continued as needed. The patient exhibited no signs of withdrawal and adequate relief of symptoms through this tapering process. At the 1-month follow-up, the patient was doing well and was being treated solely with buprenorphine and oxycodone/acetaminophen to control her breakthrough pain. After 5 months, buprenorphine was increased to 600 mcg 2x/day and her oxycodone/acetaminophen decreased to 5/325 mg 3x/day as needed. From the start of the patient's taper to her current transition, the patient reduced her morphine milligram equivalent (MME) dosage from 135 MME to 22.5 MME. The Clinical Opioid Withdrawal Scale (COWS), which measures the severity of a patient's opioid withdrawal symptoms, was consistently less than 5. This buprenorphine schedule demonstrated a successful tapering approach for this patient because she had reported improved quality of life and function. A patient-centered osteopathic treatment approach was utilized when the patient presented with mid-taper adherence difficulty. Transitioning patients from full to partial opioid agonists could become an

Topics: Acetaminophen; Analgesics, Opioid; Animals; Breakthrough Pain; Buprenorphine; Cattle; Chronic Pain; Female; Humans; Oxycodone; Quality of Life

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Orthopedic Procedures; Pain Management

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans

BACKGROUND Unwashed or unprocessed poppy seeds may be an underrecognized substance that can lead to dependence, abuse, and an opioid use disorder. Poppy seeds can be purchased in an unwashed or unprocessed form, and these seeds can be contaminated with the opium alkaloids morphine, codeine, and thebaine on their surfaces. Poppy seeds that are commercially available, such as those used for baking and in other food products, are legal to purchase, as they do not contain the opium alkaloids on their seed coats. Purchase and possession of the unwashed or unprocessed seeds are not legal in the United States. These contaminated poppy seeds can then be put through a process in which they are washed, and the supernatant (tea) is collected and consumed to experience its intoxicating effect or for the treatment of pain or opioid withdrawal. CASE REPORT A 65-year-old man with a history of alcohol use disorder, cannabis use, and chronic pain began using this poppy seed tea for treatment of chronic pain after his provider had stopped prescribing opioid pain medications for him. He developed a dependence on the tea. He had reached out for assistance as it was his desire to stop using the poppy seed tea. The diagnosis of an opioid use disorder was made using the DSM-V criteria. He was successfully induced and maintained on a buprenorphine/naloxone product. CONCLUSIONS Poppy seeds in their unwashed and unprocessed form can be misused and could lead to an opioid use disorder. This disorder can be treated with buprenorphine/naloxone products.

Topics: Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Male; Morphine; Naloxone; Opioid-Related Disorders; Opium; Papaver; Seeds; Tea

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Humans; Opioid-Related Disorders

Individuals who have substance use disorders may have an elevated risk of suicidality. This study sought to examine the prevalence of, and identify factors associated with, suicidality in adults with opioid use disorder (OUD) initiating office-based buprenorphine treatment.. Individuals were eligible to participate if they had OUD and had initiated treatment in the past month. Participants (n = 244) completed a semi-structured interview using the Addiction Severity Index-Lite.. At baseline, 37.70% of participants reported significant thoughts of suicide over their lifetime and 27.46% reported suicidal attempts over their lifetime. Logistic regression analyses were used to identify predictors of lifetime suicidal thoughts and attempts. A history of physical abuse (OR = 4.31, p < .001), having chronic pain-related conditions (OR = 3.28, p < .001), a history of depression (OR = 3.30, p = .001) or anxiety (OR = 7.47, p = .001), and Latino/a/x ethnicity (OR = 2.66, p = .01) were associated with an increased risk of lifetime suicidal thoughts. A history of sexual abuse (OR = 2.89, p = .01), Latino/a/x ethnicity (OR = 4.01, p < .001), a history of depression (OR = 4.03, p = .001) or anxiety (OR = 15.65, p = .007) and having a chronic pain-related condition (OR = 2.43, p = .01), were associated with an increased risk of lifetime suicide attempts.. Results demonstrate the high prevalence of suicidal thoughts and attempts among patients initiating buprenorphine. Findings may help to better identify at-risk patients and to inform screening, prevention, and mental health treatment efforts.. ClinicalTrials.gov, NCT04650386 (registered 12 December 2020, https://clinicaltrials.gov/ct2/show/NCT04650386 ) and NCT04257214 (registered 5 February 2020, https://clinicaltrials.gov/ct2/show/NCT04257214 ).

Topics: Adult; Buprenorphine; Chronic Pain; Humans; Prevalence; Risk Factors; Suicidal Ideation; Suicide

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Humans

Chronic pain is among the most common conditions presenting to primary care and guideline-based care faces several challenges. A novel pain management program, Video-Telecare Collaborative Pain Management (VCPM), was established to support primary care providers and meet new challenges to care presented by the COVID-19 pandemic.. The present single-arm feasibility study aimed to evaluate the feasibility and acceptability of VCPM and its components among U.S. veterans on long-term opioid therapy for chronic pain at ≥ 50 mg morphine equivalent daily dose (MEDD). VCPM consists of evidence-based interventions, including opioid reassessment and tapering, rotation to buprenorphine and monitoring, and encouraging behavioral pain and opioid-use disorder self-management.. Of the 133 patients outreached for VPCM, 44 completed an initial intake (33%) and 19 attended multiple VCPM appointments (14%). Patients were generally satisfied with VCPM, virtual modalities, and provider interactions. Nearly all patients who attended multiple appointments maintained a buprenorphine switch or tapered opioids (16/19; 84%), and buprenorphine switches were generally reported as acceptable by patients. Patients completing an initial intake with VCPM had reduced morphine equivalent daily dose after three months (means = 109 mg MEDD vs 78 mg), with greater reductions among those who attended multiple appointments compared to intake only (Δ. Pre-defined feasibility and acceptability targets for VCPM and its components were broadly met, and preliminary data are encouraging. Novel strategies to improve enrollment and engagement and future directions are discussed.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; COVID-19; Feasibility Studies; Humans; Morphine; Pain Management; Pandemics

Veterans suffer disproportionately from the combined adverse health impacts of chronic pain and hazardous opioid use. This evaluation involved a substance use treatment program that included medication for opioid use disorder (SATP-MOUD) in a large metro-area Veterans Health Administration (VHA). This form of treatment has become increasingly important during the opioid crisis and is among several important Department of Veteran's Affairs (VA) initiatives to improve treatment for opioid use disorder (OUD), for which chronic pain is often a comorbid condition.. We compared clinical measures related to substance use and mental health between groups who were considered either engaged or not engaged in completing treatment. The study used propensity score matching methods and Cox proportional hazards models to compare the mortality risk for treated and untreated veterans who had chronic pain with concurrent opioid use.. We identified 1559 SATP-MOUD patients with 1 year of pre- and post-treatment follow-time. From those with chronic pain and concurrent opioid use, we matched 478 SATP-MOUD patients to 647 untreated patients. Engaged patients (at least 4 visits in the first 8 weeks of treatment) had significant improvements in Brief Addiction Monitor (BAM) scores and in PHQ-9 depression screening scores compared to those who started treatment but did not meet the engagement threshold. In Cox proportional hazards analysis, participation in SATP-MOUD was associated with a 38% lower mortality risk among veterans with chronic pain and opioid use when compared to the untreated group: (HR: 0.62, 95% CI: 0.47, 0.82).. SATP-MOUD, as delivered in actual practice, was associated with significant improvements in depression and addiction severity scores, and was associated with reduced mortality risk for veterans with chronic pain and OUD.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders; Veterans

Office-based opioid treatment (OBOT) is an evidence-based treatment model for opioid use disorder (OUD) offered by both addiction and general primary care providers (PCPs). Calls exist for more PCPs to offer OBOT. Few studies have been conducted on the primary care characteristics of OBOT patients.. To characterize medical conditions, medications, and treatment outcomes among patients receiving OBOT with buprenorphine for OUD, and to describe differences among patients by age and by time in care.. This study is a retrospective review of medical records on or before 4/29/2019 at an outpatient primary care clinic within a nonprofit addiction treatment setting. Inclusion criterion was all clinic patients actively enrolled in the OBOT program. Patients not prescribed buprenorphine or with no OBOT visits were excluded.. Of 355 patients, 42.0% had another PCP. Common comorbid conditions included chronic pain and psychiatric diagnosis. Few patients had chronic viral hepatitis or HIV. Patients reported a median of 4 medications. Common medications were cardiovascular, antidepressant, and nonopioid pain agents. Older patients had a higher median number of medications. There was no significant difference in positive opioid urine toxicology (UT) based on age, chronic pain status, or psychoactive medications. Patients retained >1 year were less likely to have positive opioid UT.. Clinical needs of many patients receiving OBOT are similar to those of the general population, supporting calls for PCPs to provide OBOT.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Medication Therapy Management; Opiate Substitution Treatment; Opioid-Related Disorders; Primary Health Care

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; COVID-19; Humans; Opioid-Related Disorders; Pain; Quality Improvement

Data from Phase 2 of the Prescription Opioid Addiction Treatment Study (POATS) were used. Two latent transition models were conducted to characterize profiles and transitions between profiles of pain intensity or pain interference (estimated separately).. Each model identified a high and low profile. In the pain interference model, the majority were classified in the low profile at baseline. In the pain intensity model, the majority were classified in the high profile at baseline. In both models, patients were more likely to remain in or transition to the low profiles by Week 12. Worse depression was associated with membership in the high pain interference profile at both timepoints. Women were more likely to be in the high pain intensity profile at baseline. Those in the high pain intensity and high pain interference profiles at Week 12 reported worse mental health quality of life (MH-QOL) at Week 12, as well as high pain intensity and high pain interference at Week 24.. For a subgroup of patients, high pain intensity and high pain interference remains unchanged during BUP/NX maintenance treatment. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Female; Humans; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Quality of Life

The negative sequelae of full mu agonist chronic opioid analgesic therapy (COAT) are numerous and well documented. One safer alternative to COAT use in chronic, non-cancer pain (CNCP) is a transition to buprenorphine. However, transitioning patients from methadone COAT regimens can be challenging due to the pharmacodynamics of buprenorphine, as well as to the limited commercial formulations of buprenorphine available, and their restrictive instructions for use. Presented here are clinical cases transitioned to buprenorphine from methadone via a novel microinduction protocol during enrollment in an outpatient, group, integrative, multidisciplinary program. The protocol was successful to promote satisfactory and sustained COAT cessation for patients with CNCP and is arguably safer than current conventional practices.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Methadone; Opioid-Related Disorders; Outpatients

Buprenorphine is a partial mu-opioid agonist available as a transdermal patch for use in patients with chronic pain. Transdermal products can be associated with application site reactions (ASRs). The incidence of ASRs to the buprenorphine transdermal patch (BTP) have been described as low and seldom requiring patch discontinuation. In this case series, we describe four patients who developed an erythematous, rash-like ASR to the BTP leading to treatment discontinuation or rotation to buprenorphine buccal films (BBF). All subjects had demonstrated tolerability to lower patch strengths before developing an ASR with titration to a BTP of a higher strength. The strength at which an ASR emerged varied among subjects; however, all ASRs developed with BTP strengths 10 mcg/hr or higher. The dose-response relationship and prolonged onset to ASR emergence may be suggestive of an allergic delayed hypersensitivity reaction. However, in this case series three subjects demonstrated tolerability to BBF either before or after developing a skin reaction to BTP.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Transdermal Patch

Buprenorphine has been widely used in opioid medication assisted treatment (MAT) in the past decade. However, due to misinterpretation of its intrinsic mu opioid receptor activity extrapolated from preclinical and animal data, buprenorphine's clinical application in pain management has been greatly limited. Buprenorphine acts as a full mu agonist with fewer side effects compared to traditional opioids and can be effectively used in the treatment of acute and chronic pain. A strong body of evidence demonstrates that buprenorphine is an effective analgesic agent in both adult and pediatric surgical patients. In addition, buprenorphine has been successfully used in treating chronic pain, particularly in cancer pain and neuropathic pain. In this Journal course, buprenorphine's receptor pharmacology and pharmacokinetics are reviewed. Specifically, misinterpretation of its intrinsic mu receptor activity, and both analgesic ceiling effect and efficacy are clarified. Differences between suboxone and buprenorphine, and specific applications are explained. Pain management options and guidelines for surgical patients on buprenorphine are discussed, as well.

Topics: Analgesics, Opioid; Animals; Buprenorphine; Child; Chronic Pain; Evidence-Based Practice; Humans; Pain Management

Buprenorphine is a partial opioid agonist that is Food and Drug Administration (FDA) approved to treat chronic pain and opioid use disorder (OUD). The national prescribing guidelines in the United States (US) recommend that patients transitioning from full opioid agonists to buprenorphine first undergo 12 or more hours of active opioid withdrawal, in order to avoid buprenorphine-precipitated opioid withdrawal. This opioid-free period imposes a significant barrier for many patients. Evidence is accumulating that using microdoses of buprenorphine to cross taper from full-agonist opioids to buprenorphine is a safe and effective way to avoid opioid withdrawal and uncontrolled pain. This microdose cross-tapering strategy is already being used across the US. The US prescribing guidelines and buprenorphine training would benefit from acknowledging this new approach. Additionally, to facilitate this strategy, the FDA should approve transdermal buprenorphine formulations for OUD and manufacturers could produce lower dose formulations of sublingual buprenorphine. The time has come for us to embrace buprenorphine microdosing cross tapers as a new standard of care.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome; United States

Long-term opioid use in patients with chronic noncancer pain (CNCP) can lead to opioid use disorder (OUD) and has been associated with hyperalgesia and reduced quality of life (QoL). Studies suggest antihyperalgesic properties of buprenorphine, and buprenorphine or naloxone (BuNa) has shown beneficial effects on QoL in patients with OUD without CNCP. This study investigated the added value of BuNa in patients with CNCP with OUD on self-reported pain, pain thresholds, pain tolerance, and QoL. In the current study, 43 outpatients with CNCP and OUD were included for inpatient conversion from full μ-receptor agonist opioids to BuNa. Self-reported pain, pain thresholds, pain tolerance, and QoL were determined at baseline and after 2 months of follow-up, using, respectively, a Visual Analogue Scale (VAS-pain and VAS-QoL), quantitative sensory testing, and EuroQol-5 dimensions. In total, 37 participants completed the protocol, and their data were analyzed. The mean VAS-pain score decreased from 51.3 to 37.2 (27.5%, F = 3.3; P = 0.044), whereas the pressure pain threshold and electric pain threshold or tolerance increased after substitution (F = 7.8; P = 0.005 and F = 44.5; P < 0.001, respectively), as well as QoL (EuroQol-5 dimensions questionnaire: F = 10.4; P = 0.003 and VAS-QoL: F = 4.4; P = 0.043). We found that conversion of full μ-receptor agonists to BuNa, in patients with CNCP with OUD, was accompanied with lower self-reported pain, higher pain thresholds, higher pain tolerance, and improved QoL. Despite several study limitations, these data suggest that BuNa might be of value in patients with CNCP with OUD. Future studies should investigate long-term effects of BuNa in randomized trials.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Naloxone; Opioid-Related Disorders; Pain Threshold; Quality of Life

Pain management following spine surgery can be challenging as patients routinely suffer from chronic pain and opioid tolerance. The increasing popularity of buprenorphine use for pain management in this population may further complicate perioperative pain management due to the limited efficacy of other opioids in the presence of buprenorphine. This study describes perioperative management and outcomes in patients on chronic buprenorphine who underwent elective inpatient spine surgery.. The authors performed a retrospective chart review of all patients >18 years of age taking chronic buprenorphine for any indication who had elective inpatient spine surgery at a single institution. Perioperative pain management data were analyzed for all patients who underwent spine surgery and were maintained on buprenorphine during their hospital stay.. The study was performed at a single tertiary academic medical center.. The primary outcome measures were post-operative pain scores and analgesic medication requirements.. Twelve patients on buprenorphine underwent inpatient spine surgery. Acceptable pain control was achieved in all cases. Management included preoperative dose limitation of buprenorphine when indicated and the extensive use of multimodal analgesia.. The question whether patients presenting for painful, elective surgery should continue using buprenorphine perioperatively is an area of controversy, and the present manuscript provides more evidence for the concept of therapy continuation with buprenorphine.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Tolerance; Humans; Pain, Postoperative; Retrospective Studies

To provide clinical data for the conversion of Schedule II opioids to buprenorphine buccal film and to demonstrate sustained analgesia and a reduction in morphine milligram equivalents after conversion.. Retrospective review of electronic medical records.. Group clinical practice providing outpatient chronic pain management care in Winston-Salem, North Carolina.. Patients who received opioids for chronic pain between January 1, 2016, and June 30, 2019, were selected for chart review if they were converted to buprenorphine buccal film from a Schedule II opioid.. Patients who met inclusion criteria were stratified into subgroups on the basis of preconversion morphine milligram equivalents, whether they remained on opioids for breakthrough pain postconversion, and pre- and postconversion numerical rating scale pain scores. Outcomes of interest included the differences between pre- and postconversion numerical rating scale pain scores and daily morphine milligram equivalents for each subgroup.. Of 157 patients reviewed, 87.9% were successfully converted to buprenorphine buccal film. Overall, numerical rating scale pain scores were stable after conversion. Statistically significant reductions were demonstrated in the <90 daily morphine milligram equivalent subgroup. Postconversion daily morphine milligram equivalents decreased by 85.4% from baseline. Change in daily morphine milligram equivalents is representative of patients who remained on breakthrough pain medication.. Results demonstrate continued analgesia after conversion to buprenorphine buccal film despite reductions in daily morphine milligram equivalents. Most patients were able to convert directly from their long-acting opioid to buprenorphine buccal film and stabilized without the use of concomitant opioids for breakthrough pain. Aggressive titration strategies were associated with greater success.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Pain Management; Retrospective Studies

Chronic non-cancer pain (CNCP) is prevalent among individuals with opioid use disorder (OUD). However, the impact of CNCP on buprenorphine treatment outcomes is largely unknown. In this secondary analysis, we examined treatment outcomes among individuals with and without CNCP who received a low-barrier buprenorphine maintenance regimen during waitlist delays to more comprehensive opioid treatment.. Participants were 28 adults with OUD who received 12 weeks of buprenorphine treatment involving bimonthly clinic visits, computerized medication dispensing, and phone-based monitoring. At intake and monthly follow-up assessments, participants completed the Brief Pain Inventory, Beck Anxiety Inventory, Beck Depression Inventory (BDI-II), Brief Symptom Inventory (BSI), Addiction Severity Index, and staff-observed urinalysis.. Participants with CNCP (n = 10) achieved comparable rates of illicit opioid abstinence as those without CNCP (n = 18) at weeks 4 (90% vs 94%), 8 (80% vs 83%), and 12 (70% vs 67%) (P = 0.99). Study retention was also similar, with 90% and 83% of participants with and without CNCP completing the 12-week study, respectively (P = 0.99). Furthermore, individuals with CNCP demonstrated significant improvements on the BDI-II and Global Severity Index subscale of the BSI (P < 0.05). However, those with CNCP reported more severe medical problems and smaller reductions in legal problems relative to those without CNCP (P = 0.03).. Despite research suggesting that chronic pain may influence OUD treatment outcomes, participants with and without CNCP achieved similar rates of treatment retention and significant reductions in illicit opioid use and psychiatric symptomatology during low-barrier buprenorphine treatment.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders; Psychiatric Status Rating Scales

Sleep problems are common among chronic pain patients who take opioids. There are documented effects of opioids on sleep architecture; however, the long-term effects of opioids on sleep remain unknown. This study examined whether opioid-naïve participants have better sleep quality than current and previous chronic users of opioids. We also explored whether sleep differed between methadone and buprenorphine users, and whether amount of time since abstaining from opioids was associated with sleep quality.. Participants were 120 people with chronic pain (84.2% Caucasian, M. A MANCOVA revealed that all three groups with current or previous opioid use (i.e., groups 1-3) differed significantly from the opioid-naïve group (group 4) on sleep quality, sleep duration, sleep disturbances, and daytime dysfunction after controlling for sleep medications (all p < .05). For group 1 (methadone users), 2 (buprenorphine users), and 3 (prolonged abstinence), there were no statistically significant differences between each group. There was also a significant relationship between opioid-abstinent weeks and sleep disturbances in the opioid-abstinent group (r = - 0.604, p < .001).. The results of this study suggest that opioids interfere with sleep quality, even after months of abstention. Further research into the long-term effects of opioids is warranted and may contribute further to the importance of addressing sleep problems in this population.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opiate Substitution Treatment; Opioid-Related Disorders; Sleep

A significant predictor of treatment outcomes for patients with chronic non-cancer pain (CNCP) and opioid use disorder (OUD) is the degree and quality of social support they receive. Specifically, in patients with CNCP and on long-term opioid therapy, the development of OUD tends to be associated with losses in social support, while engagement in treatment for OUD improves support networks. Delivery of the evidence-based OUD treatment medications, methadone and buprenorphine, occurs in clinical environments which patently differ with respect to social support resources. The aims of this study were to describe perceived social support in patients with CNCP without OUD (no-OUD), with OUD and on buprenorphine (OUD-BP), and with OUD and on methadone (OUD-methadone).. Using the Duke Social Support Index (DSSI), perceived social support in a sample of Caucasian patients with CNCP and on opioid therapy was compared between no-OUDs (n = 834), OUD-methadone (n = 83) and OUD-BP (n = 99) therapy. Average DSSI scores were compared across groups and a linear regression model computed to describe association between group and perceived social support.. No difference was observed in DSSI scores between no-OUDs and OUD-methadone, however scores were lower among OUD-BP participants than those receiving methadone (x = -5.2; 95% CI: -7.5, -2.9) and (x = -6.5, 95% CI: -8.2, -4.9).. Patients with CNCP and OUD on methadone therapy endorse levels of social support comparable to those without OUD, however those on buprenorphine therapy report significantly less support, bringing implications for OUD treatment outcomes.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Social Support; Treatment Outcome; White People

Chronic pain is not well understood in opioid-dependent populations. We report the prevalence of chronic pain and pain characteristics in an opioid-dependent population by treatment type and gender.. This cross-sectional study opportunistically recruited 569 patients (32% women) receiving treatment for opioid use disorder (DSM-5) in Norway during 2016-2018 (83% received opioid maintenance treatment, 17% received treatment without medication). We asked about chronic pain (≥3 months; ICD-11), pain severity (NRS-11), and other pain characteristics.. Overall, 55% reported chronic pain (≥3 months), with a higher prevalence among women (61% vs 52%, P = .041) and patients receiving methadone (66%) compared with buprenorphine or no medication (46% and 45%, P < .001). Chronic pain was associated with higher age (P < .001) and higher doses of methadone (P = .048). The average duration of pain was 11 years. The most frequently reported pain locations were the lower extremities (59%) and the back (54%), and 69% reported more than one pain location. Constant pain and migrating pain were significantly associated with both moderate (adjusted odds ratio [aOR]: 2.04, confidence interval [CI]: 1.12-3.74 and aOR: 2.44, CI: 1.09-5.43) and severe pain intensity (aOR: 2.08, CI: 1.14-3.80 and aOR: 2.46, CI: 1.10-5.47). Reporting no effect of analgesics was associated with severe pain intensity (aOR: 0.54, CI: 0.29-0.99).. Over half reported chronic pain, and rates were highest among women and patients receiving methadone. New contributions to the field are descriptions of pain characteristics by gender and pain severity, and interactions between medication type and age. (© 2021 The Authors. The American Journal on Addictions published by Wiley Periodicals LLC on behalf of The American Academy of Addiction Psychiatry). (Am J Addict 2021;00:00-00).

Topics: Adolescent; Adult; Buprenorphine; Chronic Pain; Cross-Sectional Studies; Female; Humans; Male; Methadone; Middle Aged; Norway; Opiate Substitution Treatment; Opioid-Related Disorders; Prevalence; Young Adult

Practice guidelines recommend urine drug monitoring (UDM) at least annually in the setting of chronic opioid therapy as an objective assessment of substance use. However, empirical evidence on who gets tested and how often testing occurs is lacking.. This study investigates 10-year UDM trends in the United States based on 2 factors: (1) the duration of prescription opioid treatment, and (2) having an opioid use disorder (OUD) diagnosis and medications for opioid use disorder (MOUD) prescriptions.. Observational cross-sectional study.. Research was conducted using administrative claims data from Optum's deidentified Clinformatics Data Mart Database for the period 2007 to 2016. The dataset contained information on the plan enrollment and health care claims from 50 states and the District of Columbia.. To examine trends in UDM based on the duration of prescription opioid treatment, persons receiving prescription opioid analgesics were categorized into 4 groups based on the number of days covered: (a) less than 90 days, (b) 90 to 179 days, (c) 180 to 269 days, and (d) at least 270 days. To examine trends based on an OUD diagnosis and MOUD prescriptions, persons diagnosed with OUD were identified and categorized based on the presence of MOUD prescriptions as follows: (a) OUD with buprenorphine (BPN) and naltrexone (NTX) in the same year; (b) OUD with BPN only; (c) OUD with NTX only; (d) OUD with chronic prescription opioid analgesics (>= 90 days); (e) OUD without prescription opioid analgesics, BPN, or NTX; and (f) chronic prescription opioid analgesics (>= 90 days) without an OUD diagnosis. For analysis, the percent receiving UDM was estimated per group per year. Then the data were restricted to those receiving at least one UDM to estimate the average number of UDM per person.. Data included an average of 364,485 persons per year receiving prescription opioid analgesics for chronic use, and 10,277 per year receiving an OUD diagnosis. Among those receiving prescription opioid analgesics, less than 50% received UDM. For those receiving at least one UDM, one additional UDM was performed per person as the duration of opioids increased by 90 days. Among persons with OUD, the percent receiving UDM was the highest for those receiving both BPN and NTX (87%), followed by those receiving BPN only (80%), chronic opioids (79%), NTX only (72%), and those not receiving any MOUD/opioids (54%).. Methadone dispensing for OUD treatments was not captured in administrative claims data.. Although recommended for patients with chronic pain, UDM is provided less than half of the time for these patients. However, once patients received at least one UDM, they would continue to receive it on a fairly regular basis. Compared with those with chronic pain, persons diagnosed with OUD are more likely to receive UDM at a more frequent interval.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Cross-Sectional Studies; Drug Monitoring; Female; Humans; Male; Methadone; Middle Aged; Naltrexone; Opioid-Related Disorders; United States; Young Adult

Topics: Analgesics, Opioid; Anemia, Sickle Cell; Buprenorphine; Child; Chronic Disease; Chronic Pain; Humans

Buprenorphine is a Schedule III analgesic that is recommended as the firstline long-acting opioid for the treatment of chronic pain due to its ceiling effect on respiratory depression, adverse effect profile, and analgesic efficacy. However, prescription drug coverage policies commonly require that patients try and fail multiple Schedule II conventional opioids before approval of on-label use of buprenorphine for chronic pain.. A retrospective review was performed looking at coverage of buprenorphine in the forms of Butrans and Belbuca. Patient denial letters, web searches of insurance and pharmacy benefit managers (PBMs), and an online tool (formularylookup.com) were used to assess the coverage and availability of buprenorphine for chronic pain.. Unrestricted access to Butrans was reported for 42% of commercial lives and 11% of Medicare lives in all locations. Unrestricted access to Belbuca was reported for 53% of commercial lives and 23% of Medicare lives in all locations. Oxycodone immediate-release has unrestricted access for 84% of commercial plans and 97% of Medicare plans. Morphine extended-release has unrestricted access for 62% of commercial lives and 65% of Medicare lives.. There are >17,000 prescription opioid-involved deaths each year in the United States. By substituting buprenorphine as the firstline treatment for chronic and even acute pain, there may be fewer prescribed conventional opioids in the United States. Schedule III buprenorphine formulations for chronic pain should be given unrestricted access for appropriate patients before considering a Schedule II opioid as a public health priority.

Topics: Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Medicare; Retrospective Studies; United States

Despite rising morbidity and mortality from the opioid epidemic and other addictions, people who inject drugs (PWID) remain understudied regarding pain outcomes. Data among PWID regarding chronic pain and drug use, including non-medical use of opioids, is largely unknown. We examined the prevalence of chronic pain and drug use for pain in this population.. Standardized surveys captured self-report of demographics, chronic pain, and non-prescription drug use in 203 PWID in an urban syringe services program between April and November 2016. Chronic pain was defined as self-report of chronic pain diagnosis or persistent pains over the past 6 months.. Overall, 47% (95% CI, 40%-54%) of PWID reported chronic pain, while 35% (95% CI, 29%-42%) reported non-prescription drug use of any type for pain. Among those with chronic pain, drug use to treat pain was commonly reported (76%; 95% CI, 66%-83%). Non-medical opioid use did not differ among PWID with or without chronic pain or drug use for pain. A multivariable logistic regression model showed chronic pain was more likely among non-Hispanic whites and those with arthritis, older age, and homelessness.. Chronic pain serves as an important factor in the persistence of drug use in more than one-third of PWID in this sample. The high prevalence of chronic pain with drug use for pain suggests that proper pain management is likely to be an essential component of preventing or regressing injection drug use in PWID, with data needed on effective interventions for this population.

Topics: Adolescent; Adult; Age Factors; Analgesics, Opioid; Arthritis; Baltimore; Black or African American; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Cocaine-Related Disorders; Female; Heroin Dependence; Humans; Ill-Housed Persons; Male; Middle Aged; Needle-Exchange Programs; Odds Ratio; Opioid-Related Disorders; Prevalence; Risk Factors; Substance Abuse, Intravenous; White People; Young Adult

There are bidirectional links between sleep quality and pain, with recent research suggesting that sleep impairment more strongly predicts future pain than vice versa. Relatively few studies have examined the relationship between sleep quality and acute pain among chronic pain patients. The purpose of the current study is to investigate relationships among subjective sleep quality and behavioral and physiological responses to a cold pressor pain task (CPT) in chronic pain patients.. In sum, 120 individuals with chronic pain were included. Participants completed a series of questionnaires followed by the CPT. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Physiological baseline state and stress response were assessed before and during the CPT using heart rate (HR), electromyography frontalis (EMGF), galvanic skin response conductance (GSR), and skin temperature (°C). Multiple linear regressions adjusting for opioid usage were performed.. After adjusting for opioid use, PSQI global score explained significant variance in pain tolerance (B = -5.37, β = -0.23, p = 0.01), baseline GSR (B = -0.66, β = -0.24, p = 0.01), and HR change from baseline to CPT (B = 1.33, β = 0.25, p = 0.01).. Worse perceived sleep quality was associated with lower pain tolerance, lower baseline GSR conductance, and greater HR change from baseline to CPT. These findings underscore the importance of accounting for opioid usage and psychological dimensions of pain in the relationship between sleep and acute pain response in chronic pain populations.

Topics: Acute Pain; Adult; Buprenorphine; Chronic Pain; Fatigue; Female; Heart Rate; Humans; Male; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Pain Threshold; Sleep; Surveys and Questionnaires

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opioid-Related Disorders

Chronic pain is frequently comorbid with opioid abuse and severe depression, a combination that greatly compounds suicide risk. In addition to the therapeutic value of buprenorphine in addiction and analgesia, growing evidence suggests potential use as an antidepressant. Data supporting buprenorphine antisuicidal properties are scarce. We aim to contribute to the discussion of buprenorphine antisuicidal potential in patients with significant psychiatric and medical comorbidity.. We performed a chart review of suicidal adult depressed patients with comorbid chronic pain and opioid use disorder who received off-label buprenorphine in outpatient and inpatient settings in a university hospital between 2013 and 2016.. Four of the patients had an early positive response. However, only three continue to adhere to treatment for six months or longer.. More severe opioid use disorder seems to more negatively influence clinical outcome, independently of cluster b personality traits. Identification of patients who could benefit from buprenorphine will require further studies.

Topics: Adult; Analgesics, Opioid; Antidepressive Agents; Buprenorphine; Chronic Pain; Depressive Disorder; Female; Humans; Male; Middle Aged; Pain Management; Retrospective Studies; Suicidal Ideation

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Substitution; Humans; Low Back Pain; Male; Middle Aged; Oxycodone

Opioids are frequently used to manage chronic non-cancer pain despite the lack of evidence of benefit and clear evidence of opioid-related harms. Patients undergoing high-dose opioid therapy are at risk of multiple complications, such as opioid toxicity, including fatal overdose and opioid dependence.. This article provides an overview of the pharmacology of buprenorphine and reviews current evidence for the use of high-dose sublingual buprenorphine-naloxone in the pharmacological management of patients at high risk of complications from chronic opioid use.. Buprenorphine-naloxone is well tolerated by patients with chronic pain, and has the potential to improve pain scores and affective symptoms. This is exemplified in a case study based on these authors' experience in an addiction medicine setting. As the rates of pharmaceutical opioid prescribing and related harms continue to increase in Australia, buprenorphine-naloxone is a viable option to manage high-risk chronic pain patients who are unable to reduce or cease their opioid use.

Topics: Administration, Sublingual; Analgesics, Opioid; Australia; Buprenorphine; Chronic Pain; Female; Humans; Middle Aged; Pain Management; Time; Treatment Outcome

A 76-year-old woman with chronic noncancer pain and an intrathecal hydromorphone-bupivacaine pump was admitted for acute exacerbation of heart failure. Her pump was unable to be replaced due to medical comorbidities. She was unable to tolerate oral opioids due to ventilatory depression. Tapering hydromorphone resulted in opioid withdrawal due to physiological dependence. Microdosing of sublingual buprenorphine-naloxone was initiated while decreasing intrathecal hydromorphone. This successfully weaned the patient off intrathecal hydromorphone with adequate pain relief and prevented both opioid withdrawal and ventilatory depression. To our knowledge, microdosing buprenorphine-naloxone to assist with discontinuing intrathecal opioids has not been previously reported in the literature.

Topics: Aged; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Female; Humans; Hydromorphone

Topics: Analgesics, Opioid; Buprenorphine; Centers for Disease Control and Prevention, U.S.; Chronic Pain; Drug Administration Schedule; Humans; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Practice Guidelines as Topic; Practice Patterns, Physicians'; United States

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Pain Management; Treatment Outcome

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Evidence-Based Medicine; Government Regulation; Humans; Legislation, Drug; Medical Marijuana; Methadone; Opioid-Related Disorders; United States

Until recently, the belief that adequate pain management was not achievable while patients remained on buprenorphine was the impetus for the perioperative discontinuation of buprenorphine. We aimed to use an expert consensus Delphi-based survey technique to 1) specify the need for perioperative guidelines in this context and 2) offer a set of recommendations for the perioperative management of these patients. The major recommendation of this practice advisory is to continue buprenorphine therapy in the perioperative period. It is rarely appropriate to reduce the buprenorphine dose irrespective of indication or formulation. If analgesia is inadequate after optimisation of adjunct analgesic therapies, we recommend initiating a full mu agonist while continuing buprenorphine at some dose. The panel believes that before operation, physicians must distinguish between buprenorphine use for chronic pain (weaning/conversion from long-term high-dose opioids) and opioid use disorder (OUD) as the primary indication for buprenorphine therapy. Patients should ideally be discharged on buprenorphine, although not necessarily at their preoperative dose. Depending on analgesic requirements, they may be discharged on a full mu agonist. Overall, long-term buprenorphine treatment retention and harm reduction must be considered during the perioperative period when OUD is a primary diagnosis. The authors recognise that inter-patient variability will require some individualisation of clinical practice advisories. Clinical practice advisories are largely based on lower classes of evidence (level 4, level 5). Further research is required in order to implement meaningful changes in practitioner behaviour for this patient group.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Delphi Technique; Humans; Opioid-Related Disorders; Pain Management; Perioperative Care; Practice Guidelines as Topic

Topics: Adaptation, Psychological; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Time Factors

The U.S. opioid epidemic, now in its third decade, continues to claim tens of thousands of lives each year. Despite strong scientific evidence to support the deployment of effective interventions from prevention to treatment, implementation and access to quality care continue to lag, in part, due to continued opioid prescribing, siloing of treatment services for those with opioid use disorder (OUD), public support for non-evidence-based practices, stigma, and discrimination. Primary prevention efforts should focus on avoiding exposure to opioids for chronic non-cancer pain, as there is little evidence of efficacy but substantial evidence of harms. FDA-approved medications for OUD (MOUD) have incontrovertible evidence supporting their efficacy, and their use saves lives. However, fewer than 10% of those in need are able to receive MOUD. The barriers include an inadequate workforce, inadequate reimbursement, challenges navigating the treatment system, and profiteering bad actors (e.g., treatment brokers, programs delivering non-evidenced-based care). Perhaps the greatest challenge (and deterrent from receiving MOUD) is stigma and lack of public knowledge about their efficacy. Detoxification is probably the most common form of "treatment" for OUD, but the evidence shows that detoxification actually increases the risk for overdose. Expansion of MOUD delivery in the criminal justice system, health care systems and communities is essential to stemming the tide of this epidemic. This article is a call to action for the scientific community to ensure that scientific evidence is guiding patient care, funding for treatment, and policy decisions that address the opioid epidemic.

Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Behavior Therapy; Buprenorphine; Chronic Pain; Female; Humans; Male; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment; Opioid Epidemic; Opioid-Related Disorders; Practice Guidelines as Topic; United States

Opioids are a widely prescribed class of drug with potentially harmful short-term and long-term side effects. There are concerns about the amounts of these drugs being prescribed in England given that they are increasingly considered ineffective in the context of long-term non-cancer pain, which is one of the major reasons for their prescription.. To assess the amount and type of opioids prescribed in primary care in England, and patterns of regional variation in prescribing.. Retrospective observational study using publicly available government data from various sources pertaining to opioids prescribed in primary practice in England and Indices of Social Deprivation.. Official government data were analysed for opioid prescriptions from August 2010 to February 2014. The total amount of opioid prescribed was calculated and standardised to allow for geographical comparisons.. The total amount of opioid prescribed, in equivalent milligrams of morphine, increased (. Long-term opioid prescribing is increasing despite poor efficacy for non-cancer pain, potential harm, and incompatibility with best practice. Questions of equality of care arise from higher prescription rates in the north of England and in areas of greater social deprivation. A national registry of patients with high opioid use would improve patient safety for this high-risk demographic, as well as provide more focused epidemiological data regarding patterns of prescribing.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Crime; Databases, Factual; Education; Employment; England; Health Status; Housing; Humans; Income; Methadone; Morphine; Oxycodone; Practice Patterns, Physicians'; Primary Health Care; Residence Characteristics; Retrospective Studies; Socioeconomic Factors; Tramadol

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Prescriptions; Government Regulation; Humans; Legislation, Drug; Opiate Substitution Treatment; Opioid-Related Disorders; United States

HIV-infected persons are more likely to have chronic pain, receive opioid analgesic treatment, receive higher doses of opioids, and to have substance use disorders and mental illness compared with the general population, putting them at increased risk for opioid use disorder. Management of opioid use in HIV-infected individuals can be complex, and the limited data on opioid treatment in this population are conflicting with regard to its effect on HIV outcomes. Buprenorphine treatment for opioid use disorder improves HIV outcomes and other outcomes. This article summarizes a presentation by Chinazo O. Cunningham, MD, MS at the IAS-USA continuing education program, Improving the Management of HIV Disease, held in Atlanta, Georgia, in March 2017.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; HIV Infections; Humans; Opioid-Related Disorders; Pain Management

Screening for opioid use disorder should be considered in chronic non-cancer pain (CNCP) patients with long-term use of opioids. The aim of our study was to assess the effectiveness of an individualized treatment plan (ITP) for prescription opioid dependence that included screening of pharmacogenetic markers. An observational prospective study was performed using prescription opioid-dependent CNCP outpatients (n = 88). Patients were divided into nonresponders, responders, or high responders according to their response to the ITP. Genotyping of OPRM1 (A118G), OPRD1 (T921C), COMT (G472A), ABCB1 (C3435T), and ARRB2 (C8622T) was performed by real-time PCR. Our ITP achieved a significant reduction of the morphine equivalent daily dose (MEDD) in 64% of responders, including 33% of high responders. Nonopioid medication or buprenorphine use was significantly higher at final versus basal visit. 118-AA OPRM1 patients required significantly lower MEDD at basal and final visits. Our ITP showed effectiveness and security in reducing MEDD in opioid-dependent patients, with good conversion to buprenorphine that was more pronounced in 118-AA OPRM1 patients.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Gene Frequency; Genotype; Humans; Male; Middle Aged; Opioid-Related Disorders; Pharmacogenetics; Polymorphism, Single Nucleotide; Prospective Studies; Receptors, Opioid, mu

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Compounding; Humans

We aimed to evaluate a novel clinical program designed to address unsafe use of opioids prescribed for pain-the Opioid Reassessment Clinic (ORC)-to inform practice and health system improvement.. Controlled, retrospective cohort study.. The ORC is a multidisciplinary clinic in a primary care setting in a Veterans Health Administration hospital designed to perform longitudinal treatment of patients with unsafe use of opioids prescribed for pain, including tapering or rotating to the partial opioid agonist buprenorphine.. We included patients referred to the ORC from March 1, 2016, to March 1, 2017, who had an intake appointment (intervention group) and who did not (control group).. We compared a priori-defined metrics at the patient, clinic process, and health system levels and compared metrics between groups.. During the study period, 114 veterans were referred to the ORC, and 71 (62%) of these had an intake appointment. Those in the intervention group were more likely to trial buprenorphine (N = 41, 62% vs N = 1, 2%, P < 0.01) and had greater reductions in their full agonist morphine equivalent daily dose than those in the control group (30 mg [interquartile range {IQR} = 0-120] vs 0 mg [IQR = 0-20] decrease, P < 0.01). Of those engaging in the ORC, 20 (30%) had not transitioned chronic pain management back to their primary care providers (PCPs) by the end of follow-up. Only one patient transitioned the management of buprenorphine to the PCP.. Results suggest the ORC was effective in reducing total prescribed opioid doses and in transitioning patients to partial-agonist therapy, but PCP adoption strategies are needed.

Topics: Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Cohort Studies; Combined Modality Therapy; Female; Humans; Male; Middle Aged; Pain Clinics; Quality Improvement; Retrospective Studies

The prevalence of opioid-induced hyperalgesia (OIH) among patients maintained on opioids for chronic non-malignant pain has not been estimated. As a contribution toward establishing its prevalence, we report a case series of opioid maintained patients whose pain tolerance was measured by the cold pressor test at baseline.. A case series of 117 patients who had undergone detoxification was reviewed retrospectively. Most patients (n = 108) and selected non-addicted support persons who accompanied them (controls; n = 37) had cold pressor time (CPT) assessments at baseline. Twenty patients had a repeat CPT after 1 month.. When 61 patients completed one month abstinent reported pain was improved (51%), unchanged (46%), or worse (3%). Baseline CPT was 48 sec for patients and 102 sec for controls, suggesting that opioid maintained patients were more pain sensitive than opioid naïve controls. CPT increased for 90% of 1-month completers, suggesting improved pain tolerance. Ameliorative response to detoxification, psychotherapy, and medical management, as defined as the absence of worsening pain with removal of opioids, was 97% in this population.. The difference in CPT between opioid maintained patients and controls, and the response to detoxification, psychotherapy and medical management suggest the possibility that the prevalence of OIH may be high.. This study adds to the growing evidence that chronic opioid treatment contributes little to the management of chronic pain and in fact appears to frequently make it worse. (Am J Addict 2017;26:738-743).

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Hyperalgesia; Male; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment; Pain Management; Pain Threshold; Psychotherapy; Treatment Outcome

New Rhode Island regulations require physicians and other licensed practitioners to make significant adjustments to comply with new requirements for prescribing narcotics for chronic pain. Responding to the opioid epidemic, the new rules are intended to improve patient safety by changing physicians' prescribing patterns. However, the new rules may overlook the importance of treatment-access problems and the importance of buprenorphine products for treating pain and opioid dependence. Empirical data have demonstrated the safety and efficacy of buprenorphine in treating opioid-dependent patients with chronic pain, including those with and without substance abuse histories, but access to buprenorphine treatment remains limited throughout the state. The new regulations call upon physicians to make use of consultation services, which are also of limited availability. Although well intentioned, the new rules may contribute to treatment-access problems, and patients with chronic pain may resort to higher-risk "street" drugs when they are unable to access safe but effective medical treatment. [Full article available at http://rimed.org/rimedicaljournal-2017-10.asp].

Topics: Analgesics, Opioid; Buprenorphine; Centers for Disease Control and Prevention, U.S.; Chronic Pain; Drug and Narcotic Control; Health Policy; Humans; Opiate Substitution Treatment; Opioid-Related Disorders; Practice Guidelines as Topic; Practice Patterns, Physicians'; Rhode Island; United States

To evaluate utilization patterns in patients initiating buprenorphine transdermal system (BTDS), CIII, and estimate the proportion decreasing their total opioid dose over time.. This retrospective cohort study used data from the Truven Health Analytics MarketScan® Commercial Claims and Encounters Database from 1 January 2011 through 31 December 2015. Eligible individuals were adults aged 18-64 years newly dispensed BTDS (index prescription) who had at least six months of insurance coverage prior to (baseline period) and following (study period) the index prescription.. Back and neck pain was the most common pain condition in the study population (n = 31,533) and 88% were dispensed opioids in the baseline period. Nearly half (48%) received BTDS in a strength of 10 mcg/hour as their index prescription. Most (80%) patients prescribed BTDS had concomitant prescriptions for other opioids, chiefly immediate-release (IR) opioids (77%). During the baseline period, median opioid dose among patients prescribed opioids was 50 morphine-equivalent doses (MED), with 33% of patients using nonsteroidal anti-inflammatory drugs and 44% adjuvant analgesics. During the study period, BTDS use lasted a median 30 days and mean 100 days. Median dose of BTDS remained largely constant, and median dose of all opioids during continuous use of BTDS was 65.6 units MED. However, 24% of patients reduced total units MED from the baseline period (median mean dose, 74.5 units MED) until the end of the study period (42.8).. Most patients initiating treatment with BTDS had a history of treatment with IR opioids. Though the average change in total opioid daily dose after patients were prescribed BTDS was modest, an important subpopulation of approximately one-quarter of patients were able to markedly reduce their total units MED compared with prior opioid therapy. BTDS should be investigated as an option to help patients step down from higher opioid doses.

Topics: Administration, Cutaneous; Adolescent; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Chronic Pain; Cohort Studies; Dose-Response Relationship, Drug; Female; Humans; Low Back Pain; Male; Middle Aged; Neck Pain; Practice Patterns, Physicians'; Retrospective Studies; United States; Young Adult

Prescription opioid related abuse, suicide and death are significant public health problems. This study compares rates of poison center calls categorized as intentional abuse, suspected suicidal intent or fatality for the 7-day buprenorphine transdermal system/patch (BTDS) with other extended-release and long-acting (ER/LA) opioids indicated for chronic pain.. Retrospective 24-month cohort study using National Poison Data System data from July 2012 through June 2014. BTDS was introduced in the United States in January 2011. Numbers and rates of calls of intentional abuse, suspected suicidal intent and fatalities were evaluated for BTDS, ER morphine, ER oxycodone, fentanyl patch, ER oxymorphone and methadone tablets/capsules, using prescription adjustment to account for community availability. Rate ratios (RR) and 95% confidence intervals (CI) were calculated.. Absolute numbers and prescription-adjusted rates of intentional abuse and suspected suicidal intent with BTDS were significantly lower (p < .0001) than for all other ER/LA opioid analgesics examined. No fatalities associated with BTDS exposure were reported.. This post-marketing evaluation of BTDS indicates infrequent poison center calls for intentional abuse and suspected suicidal intent events, suggesting lower rates of these risks with BTDS compared to other ER/LA opioids.

Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Cause of Death; Chronic Pain; Cohort Studies; Female; Humans; Male; Middle Aged; Poison Control Centers; Prescription Drug Misuse; Retrospective Studies; Sex Factors; Suicide; Transdermal Patch; United States

To evaluate whether buprenorphine transdermal system (BTDS; Butrans®) is an option for the treatment of chronic pain in older adults.. This retrospective analysis of 16 placebo- and active-controlled and uncontrolled studies (N = 6566) evaluated the safety and tolerability profile in patients exposed to BTDS and compared the safety profiles associated with BTDS treatment in older patients ≥ 65 years of age (65 to 98 years) and younger patients < 65 years of age (18 to 64 years). Safety analyses included adverse events (AEs), laboratory values, and electrocardiograms.. Overall, the incidence of AEs was similar in the ≥ 65 year patient cohort (N = 1715) and the < 65 year patient cohort (N = 4843) (63.8% and 61.0%, respectively). The older patient cohort experienced more constipation, peripheral edema, and urinary tract infection, but fewer application-site AEs (eg, erythema, irritation, pruritus, rash) and headaches. A statistically significant treatment-by-age interaction was observed for fall, arthralgia, and localized and non-application site-related rash, suggesting a differential increase in the risk of these events among older patients treated with BTDS that cannot be explained by age or treatment alone. A similar trend was observed for accidents and injuries, and for falls, in patients treated with both BTDS and active controls (oxycodone/acetaminophen [OXY/APAP] and hydrocodone/acetaminophen [HCD/APAP]), suggesting an opioid class effect. However, due to small sample sizes of the active control groups, a statistical test of treatment-by-age interaction could not be conducted for the active controls. The incidences of serious AEs and of clinically significant increases in liver enzymes, such as AST, ALT and bilirubin were small, regardless of age.. BTDS appears to be a viable option for the management of pain in older adults, but the benefits need to be tempered by potential risks among older adults.

Topics: Administration, Cutaneous; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Cohort Studies; Double-Blind Method; Female; Humans; Male; Middle Aged; Retrospective Studies; Risk Assessment; Young Adult

Buprenorphine-naloxone (BUP-NLX) can be used to manage prescription opioid addiction among persons with chronic pain, but post-treatment relapse is common and difficult to predict. This study estimated whether changes in pain over time and pain volatility during BUP-NLX maintenance would predict opioid use during the taper BUP-NLX taper.. Secondary analysis of a multi-site clinical trial for prescription opioid addiction, using data obtained during a 12-week BUP-NLX stabilization and 4-week BUP-NLX taper.. Community clinics affiliated with a national clinical trials network in 10 US cities.. Subjects with chronic pain who entered the BUP-NLX taper phase (n = 125) with enrollment occurring from June 2006 to July 2009 (52% male, 88% Caucasian, 31% married).. Outcomes were weekly biologically verified and self-reported opioid use from the 4-week taper phase. Predictors were estimates of baseline severity, rate of change and volatility in pain from weekly self-reports during the 12-week maintenance phase.. Controlling for baseline pain and treatment condition, increased pain [odds ratio (OR) = 2.38, P = 0.02] and greater pain volatility (OR = 2.43, P = 0.04) predicted greater odds of positive opioid urine screen during BUP-NLX taper. Increased pain (IRR = 1.40, P = 0.04) and greater pain volatility [incidence-rate ratio (IRR) = 1.66, P = 0.009] also predicted greater frequency of self-reported opioid use.. Adults with chronic pain receiving out-patient treatment with buprenorphine-naloxone (BUP-NLX) for prescription opioid addiction have an elevated risk for opioid use when tapering off maintenance treatment. Those with relative persistence in pain over time and greater volatility in pain during treatment are less likely to sustain abstinence during BUP-NLX taper.

Topics: Adult; Buprenorphine; Chronic Pain; Drug Therapy, Combination; Female; Humans; Male; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Severity of Illness Index; Treatment Outcome; United States

Opioid treatment for chronic pain is a known risk factor for falls and/or fractures in elderly patients. The latter cause a significant cost to the National Health Service and the Personal Social Services in the UK. Tramadol has a higher risk of fractures than some other opioid analgesics used to treat moderate-to-severe pain and, in the model described here, we investigate the cost effectiveness of transdermal buprenorphine treatment compared with tramadol in a high-risk population.. A model was developed to assess the cost effectiveness of tramadol compared with transdermal buprenorphine over a 1-year time horizon and a patient population of high-risk patients (female patients age 75 or older). To estimate the total cost and quality-adjusted life years (QALYs) of treatment, published odds ratios are used in combination with the published incidence rates of four types of fracture: hip, wrist, humerus and other.. The model shows tramadol to be associated with 1,058 more fractures per 100,000 patients per year compared with transdermal buprenorphine, resulting in transdermal buprenorphine being cost-effective with an incremental cost-effectiveness ratio of less than £7,000 compared with tramadol. Sensitivity analysis found this result to be robust.. In the UK data, there is uncertainty regarding the transdermal buprenorphine odds ratios for fractures. Odds ratios published in Danish and Swedish studies show similar point estimates but are associated with less uncertainty.. Transdermal buprenorphine is cost-effective compared to tramadol at a willingness-to-pay threshold of £20,000 per QALY.

Topics: Aged; Aged, 80 and over; Buprenorphine; Chronic Pain; Cost-Benefit Analysis; Drug Costs; Female; Fractures, Bone; Health Care Costs; Humans; Models, Economic; Quality-Adjusted Life Years; Risk Factors; Tramadol; Transdermal Patch; United Kingdom

Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy.. Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status.. At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes.. Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Depression; Double-Blind Method; Female; Humans; Low Back Pain; Male; Middle Aged; Pain Measurement; Quality of Life; Treatment Outcome

Opioids provide effective analgesia for moderate-to-severe, chronic pain. Transdermal buprenorphine (TDB) is available in the UK as weekly, lower-dose (5-20 μg/h) patches and twice-weekly, higher dose (35-70 μg/h) patches. This prospective, observational, multicenter study of patients with various chronic pain conditions assessed the safety, perceptions, and discontinuation of treatment with TDB in a real-world, non-interventional setting (ClinicalTrials.gov study ID: NCT01225861).. Patients aged ≥18 years who were already receiving or initiating treatment with TDB were recruited in the UK during routine clinical visits and were followed for 6 visits or 9 months (whichever came first). Self-reported treatment adherence, patient satisfaction, and safety data were collected at each study visit.. Of 465 patients, 272 were already receiving 7-day TDB at the study start (TDB experienced), 146 were TDB naïve, and 47 were prescribed twice-weekly TDB. Most patients were female (72.9 %) and overweight/obese (body mass index ≥25: 75.3 %). The median age was 67 years, and the mean duration of pain was 11.1 years. Arthritis/other musculoskeletal disorders (39.6 %) were the most common causes of pain. Mild adverse events were commonly reported. Skin irritations, which were most frequent in 7-day TDB-experienced patients (45.6 %), rarely resulted in treatment discontinuation (8.8 %). Nearly all patients used TDB in accordance with treatment recommendations. Most patients reported that TDB was 'effective'/'very effective' at relieving pain and were 'satisfied'/'very satisfied' with TDB therapy.. In everyday clinical practice, TDB was well tolerated and patients were satisfied with their therapy. Self-reported adherence to TDB was very high, and adverse events rarely resulted in treatment discontinuation. Opportunities were identified to limit common adverse events associated with TDB.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Female; Humans; Male; Medication Adherence; Middle Aged; Pain Measurement; Patient Satisfaction; Prospective Studies; United Kingdom

Rising overdose fatalities among U.S. veterans suggest veterans taking prescription opioids may be at risk for overdose. However, it is unclear whether veterans prescribed chronic opioids are aware of this risk. The objective of this study was to identify risk factors and determine awareness of risk for opioid overdose in veterans treated with opioids for chronic pain, using veterans treated with methadone or buprenorphine for opioid use disorder as a high-risk comparator group. In the current study, 90 veterans on chronic opioid medication, for either opioid use disorder or pain management, completed a questionnaire assessing risk factors, knowledge, and self-estimate of risk for overdose. Nearly all veterans in both groups had multiple overdose risk factors, although individuals in the pain management group had on average a significantly lower total number of risk factors than did individuals in the opioid use disorder group (5.9 versus 8.5, p < .0001). On average, participants treated for pain management scored slightly but significantly lower on knowledge of opioid overdose risk factors (12.1 versus 13.5, p < .01). About 70% of participants, regardless of group, believed their overdose risk was below that of the average American adult. There was no significant relationship between self-estimate of overdose risk and either number or knowledge of opioid overdose risk factors. Our results suggest that veterans in both groups underestimated their risk for opioid overdose. Expansion of overdose education to include individuals on chronic opioids for pain management and a shift in educational approaches to overdose prevention may be indicated.

Topics: Adult; Aged; Analgesics, Opioid; Behavior, Addictive; Buprenorphine; Chronic Pain; Drug Overdose; Female; Humans; Male; Methadone; Middle Aged; Midwestern United States; Opioid-Related Disorders; Pain Management; Prescription Drugs; Risk Factors; Veterans

Prescription opioid abuse and diversion are major causes of morbidity and mortality in the United States. The buprenorphine transdermal delivery system (BTDS) is indicated for the treatment of moderate to severe chronic pain and provides a continuous dose of 5, 7.5, 10, 15, or 20 μg/h buprenorphine for 7 days. Quarterly rates of abuse and diversion of BTDS were compared with 4 comparator groups: 1) other buprenorphine products, 2) fentanyl patches, 3) extended-release (ER) opioid tablets/capsules, and 4) ER tramadol. Data were obtained from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Poison Center, Drug Diversion, Treatment Programs Combined (Opioid Treatment and Survey of Key Informants' Patients Programs), and College Survey Programs. Rates were calculated using case counts per population and mentions per prescriptions filled. Poisson regression analysis was used to compare mean rates over time across drug groups after allowing for drug group-specific dispersion parameters. Population adjusted abuse rates were low for BTDS in all of the RADARS System programs compared with the other comparator groups. Findings were similar for the prescription adjusted rates, with BTDS reported at the lowest rates in all programs. Route of abuse differed slightly for BTDS and the comparator groups depending on the program. BTDS was abused and diverted at low rates compared with the other opioid groups in 5 programs of the RADARS System using either population-based rates or prescription dispensed rates.. Data from the RADARS System show the BTDS is abused and diverted at low rates compared with other opioid groups including other forms of buprenorphine, fentanyl patches, ER opioid formulations, and ER tramadol.

Topics: Administration, Cutaneous; Adolescent; Adult; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Female; Fentanyl; Humans; Male; Middle Aged; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Diversion; Surveys and Questionnaires; United States; Young Adult

Posttraumatic stress disorder (PTSD), chronic pain, and substance use disorders are prevalent co-occurring conditions that are challenging to treat individually, and there is no evidence-based treatment for all 3. Buprenorphine, used to treat opioid use disorder and chronic pain, is a partial nociceptin opioid receptor agonist. In preclinical studies, a nociceptin opioid receptor agonist was shown to mitigate PTSD symptoms in acute trauma. We compared buprenorphine to other opioid medications in its impact on PTSD symptoms in patients with chronic pain and opioid and/or other substance use disorders.. We assembled a retrospective cohort of 382 Iraq and Afghanistan veterans in US Department of Veterans Affairs health care from October 1, 2007, to July 29, 2013, with ICD-9-CM diagnoses of PTSD, chronic pain, and substance use disorders. We used time-varying general estimating equation models to assess the primary outcome, which was change in PTSD symptoms (measured using the PTSD Checklist and the Primary Care PTSD Screen) among veterans initiated on sublingual buprenorphine versus those maintained on moderately high-dose opioid therapy.. Twice as many veterans in the buprenorphine group (23.7%) compared to those in the opioid therapy group (11.7%) experienced improvement in PTSD symptoms (P = .001). Compared to veterans in the opioid therapy group, veterans receiving buprenorphine showed significant improvement in PTSD symptoms after 8 months, with increasing improvement up to 24 months (incidence rate ratio = 1.79; 95% CI, 1.16-2.77; P = .009). There were no differences in the longitudinal course of pain ratings between groups.. This observational study is the first to report an incidental effect of buprenorphine compared to opioid therapy in improving PTSD symptoms in veterans.

Topics: Adult; Afghan Campaign 2001-; Buprenorphine; Chronic Pain; Comorbidity; Female; Humans; Iraq War, 2003-2011; Male; Narcotic Antagonists; Nociceptin; Opiate Substitution Treatment; Opioid Peptides; Opioid-Related Disorders; Outcome Assessment, Health Care; Receptors, Opioid; Retrospective Studies; Stress Disorders, Post-Traumatic; United States; Veterans

Topics: Administration, Buccal; Analgesics, Opioid; Buprenorphine; Chemistry, Pharmaceutical; Chronic Pain; Dosage Forms; Drug Administration Schedule; Drug Interactions; Humans; Treatment Outcome

Evidence supports the use of opioids for treating acute pain. However, the evidence is limited for the use of chronic opioid therapy for chronic pain. Furthermore, the risks of chronic therapy are significant and may outweigh any potential benefits. When considering chronic opioid therapy, physicians should weigh the risks against any possible benefits throughout the therapy, including assessing for the risks of opioid misuse, opioid use disorder, and overdose. When initiating opioid therapy, physicians should consider buprenorphine for patients at risk of opioid misuse, opioid use disorder, and overdose. If and when opioid misuse is detected, opioids do not necessarily need to be discontinued, but misuse should be noted on the problem list and interventions should be performed to change the patient's behavior. If aberrant behavior continues, opioid use disorder should be diagnosed and treated accordingly. When patients are discontinuing opioid therapy, the dosage should be decreased slowly, especially in those who have intolerable withdrawal. It is not unreasonable for discontinuation of chronic opioid therapy to take many months. Benzodiazepines should not be coprescribed during chronic opioid therapy or when tapering, because some patients may develop cross-dependence. For patients at risk of overdose, naloxone should be offered to the patient and to others who may be in a position to witness and reverse opioid overdose.

Topics: Acute Pain; Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Overdose; Education, Medical, Continuing; Humans; Male; Naloxone; Opioid-Related Disorders; Practice Guidelines as Topic; Practice Patterns, Physicians'; Risk Assessment; United States

In a sample of patients receiving opioid agonist therapy, we evaluated whether having chronic pain was associated with (a) craving for opioids and (b) illicit opioid use.. In a cross-sectional study of adults on buprenorphine or methadone maintenance recruited from an urban medical center, we examined any craving for opioids (primary dependent variable) in the past week and recent illicit opioid use (secondary dependent variable). Illicit opioid use was defined as a positive urine drug test (UDT) for opiates and chronic pain was defined as bodily pain that had been present for at least 3 months. Multivariable logistic regression models were fit for each outcome, adjusting for age, sex, and non-white race. Additional models adjusted for depression (PHQ-9) and anxiety (STAI).. The sample included 105 adults on methadone or buprenorphine maintenance. Mean age was 43.8 (SD ±9.4)years; 48% were female and 32% non-white; 19% were on methadone. Chronic pain was present in 68% of the sample, 51% reported craving opioids in the past week, and 16% had a positive UDT. Chronic pain was associated with 3-fold higher odds of reporting craving in the past week (aOR=3.10; 95% CI: 1.28-7.50, p-value=0.01). The relative odds for having a positive UDT were not statistically significant (aOR=2.52; 95% CI: 0.64-9.90, p=0.18).. In this sample of patients treated with opioid agonist therapy, those with chronic pain had higher odds of reporting craving for opioids. Chronic pain with associated opioid craving potentially places this population at risk for relapse.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Craving; Cross-Sectional Studies; Depression; Female; Humans; Male; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders

To estimate the prevalence of new initiation of long-acting opioids since introduction of national efforts to increase prescriber and public awareness on safe use of transdermal fentanyl patches.. Cross-sectional.. U.S. nursing homes (NHs).. Medicare-enrolled long-stay NH residents (N = 22,253).. Minimum Data Set 3.0 was linked with Medicare enrollment, hospital claims, and prescription drug transaction data (January-December 2011) and used to determine the prevalence of new initiation of a long-acting opioid prescribed to residents in NHs.. Of NH residents prescribed a long-acting opioid within 30 days of NH admission (n = 12,278), 9.4% (95% confidence interval = 8.9-9.9%) lacked a prescription drug claim for a short-acting opioid in the previous 60 days. The most common initial prescriptions of long-acting opioids were fentanyl patch (51.9% of opioid-naïve NH residents), morphine sulfate (28.1%), and oxycodone (17.2%).. New initiation of long-acting opioids-especially fentanyl patches, which have been the subject of safety communications-persists in NHs.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug Utilization; Female; Fentanyl; Homes for the Aged; Humans; Long-Term Care; Male; Morphine; Nursing Homes; Oxycodone; Oxymorphone; Practice Patterns, Physicians'; Rhode Island; Tramadol

Psychiatric comorbidities complicate treatment of patients with chronic pain and opioid use disorder, but the prevalence of specific comorbid psychiatric disorders in this population has not been systematically investigated.. 170 consecutive participants entering a treatment research program for co-occurring chronic pain and opioid use disorder between March 2009 and July 2013 were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I/P) and the Diagnostic Interview for DSM-IV Personality Disorders (DIPD-IV).. The prevalence of any lifetime (and current) comorbid Axis I disorder was 91% (75%); 52% met criteria for lifetime anxiety disorder (48% current), 57% for lifetime mood disorder (48% current), and 78% for lifetime nonopioid substance use disorder (34% current). Common current anxiety diagnoses were posttraumatic stress disorder (21%), generalized anxiety disorder (16%), and panic disorder without agoraphobia (16%). Common current mood diagnoses were major depressive disorder (40%) and dysthymia (11%). A majority of patients had a personality disorder (52%).. High rates and persistence of co-occurring psychiatric disorders, including anxiety or mood disorders, may explain in part the difficulty providers have treating patients with co-occurring opioid use disorder and chronic pain and suggest possible targets for improving treatment.. ClinicalTrials.gov identifiers: buprenorphine/naloxone treatment (NCT00634803), opioid treatment program-based methadone maintenance treatment (NCT00727675).

Topics: Adult; Buprenorphine; Chronic Pain; Comorbidity; Cross-Sectional Studies; Disability Evaluation; Female; Heroin Dependence; HIV Seropositivity; Humans; Illicit Drugs; Male; Mental Disorders; Methadone; Middle Aged; Naloxone; Opioid-Related Disorders; Pain Measurement; Prescription Drugs; Young Adult

Buprenorphine, a semisynthetic thebaine derivative, is a unique opioid, as it has activity at multiple receptors, including mu (partial agonist), kappa (antagonist), OLR-1 (agonist), and delta (antagonist). Because buprenorphine's pharmacology is relatively complex, misconceptions about its actions are common. Most other opioids act solely or predominately as full mu receptor agonists. Common practice at many institutions calls for the cessation of regular buprenorphine use 48-72 hours prior to surgery. This practice is based on three foundational theories that have come from scant data about the properties of buprenorphine: (1) that buprenorphine is only a partial mu agonist and therefore is not a potent analgesic; (2) because buprenorphine has a ceiling effect on respiratory depression, it also has a ceiling effect on analgesia; and (3) that buprenorphine acts as a "blockade" to the analgesic effects of other opiates when coadministered due to its strong binding affinity. However, several recent studies have called this practice into question. At our institution, we continue buprenorphine perioperatively, whenever possible, in order to provide superior pain control, discourage potentially problematic use and the more dangerous side effects of full mu agonist opiates, and avoid putting recovery at risk for those with opiate dependency issues. We present a unique case comparing two different outcomes for the same surgical course performed at two different times on the same chronic pain patient. These differences may be attributable to the variable of buprenorphine being present for one perioperative course and not the other. Pain control was easier to achieve, and functional recovery was greater when buprenorphine was maintained throughout the perioperative period when compared with using a full mu agonist opioid for chronic pain preoperatively. This is an outcome that much of the literature heretofore suggests would be unlikely. We review some aspects of buprenorphine's unique pharmacology that may explain why remaining on buprenorphine perioperatively may be preferable, which contradicts many practice guidelines.

Topics: Administration, Sublingual; Analgesics, Opioid; Arthroplasty, Replacement, Knee; Buprenorphine; Chronic Pain; Humans; Male; Middle Aged; Perioperative Care; Recovery of Function; Treatment Outcome

Background and aims Chronic pain is a life altering condition and common among elderly persons. The 7-day buprenorphine patch could be a suitable treatment for managing chronic pain of moderate severity in elderly patients in Sweden. The objective of this analysis was to investigate the cost-effectiveness of the 7-day buprenorphine patch, versus no treatment, in patients >50 years old who suffer from moderate pain in a health economic perspective. An additional aim was to evaluate how the cost-effectiveness is affected by the choice of EQ-5D weights. Methods The annual treatment cost and the potential gains in health-related quality of life (HRQoL) of buprenorphine, compared to no treatment, were evaluated. Original EQ-5D data were collected from four clinical reference studies at baseline and at the final visit. Treatment effects on HRQoL were then assessed using both UK and Swedish EQ-5D weights. Annual treatment costs were calculated based on costs of physician visits and pharmaceuticals. The optimal treatment dose was 10-15 μg/h and the analysis was hence performed on both a 10- and a 15 μg/h buprenorphine patch. Results The analysis of buprenorphine treatment resulted in improved HRQoL in all reference studies, irrespective of choice of EQ-5D weight set. The change in quality adjusted life years (QALYs) varied with a gain of 0.042-0.118 using the UK weights and 0.020-0.051 with the Swedish weights. The average annual treatment cost was SEK14454 for the 10μg/h patch and SEK17 017 for the 15 μg/h patch, while cost for the no-treatment alternative was SEK 9 960. The base case incremental cost-effectiveness ratios (ICER) with the UK weights were SEK 40000-SEK 170000 and SEK 90000-SEK 350000 when applying the Swedish weights. The corresponding ICER-span in the sensitivity analysis was SEK 15 000-SEK 400 000 when applying the UK weights and SEK 30 000-SEK 840 000 with the Swedish weights (SEK 100 is about €11). Conclusions The results imply that the 7-day buprenorphine patch may be a cost-effective treatment of moderate chronic pain in patients over 50 years of age. The UK and the Swedish EQ-5D weights generated vastly different HRQoL estimates but buprenorphine remains cost-effective regardless choice of weight set.

Topics: Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Clinical Trials as Topic; Cost-Benefit Analysis; Female; Health Care Costs; Humans; Male; Middle Aged; Pain Measurement; Patient Outcome Assessment; Quality of Life; Quality-Adjusted Life Years; Sweden; Transdermal Patch; Treatment Outcome

Persistence, the duration a patient remains on therapy, in chronic, symptomatic conditions plays an important role in therapy effectiveness. Understanding the duration and patient factors associated with prescribed medication persistence is, therefore, an important step toward better treatment and health outcomes for patients. In the following study, an analysis of such factors associated with buprenorphine transdermal system (BTDS) persistence was conducted utilizing a large US private practitioner and pharmacy claims database and is herein reported.. Patients aged ≥ 18 years initiating BTDS during January 1, 2011-November 30, 2011 were identified in the IMS Private Practitioner Medical Claims and Pharmacy Claims databases. An index date was defined as the first prescription of BTDS during the studied interval. During the preindex period, Charlson Comorbidity Index (CCI), chronic pain-related conditions, and prior medication use were assessed. Concomitant medications and various treatment patterns (eg, last dose strength and dose adjustments) were assessed in the postindex 6-month period. Persistence was measured as the duration of BTDS from initiation to the 1st >28-day refill gap in the postindex 6-month period. Descriptive statistical and survival analysis was used to assess the predictors of BTDS persistence.. During the study period, 10,457 patients newly treated with BTDS were identified. Patients' mean (± SD) age was 54.5 (± 15.2) years; 69.9% were women, and the mean (± SD) CCI was 1 (± 1.4). Utilizing a hierarchical approach, patients were separated into different cohorts based on the initial analgesic prescription identified during postindex period with 91.7%, 34.7%, and 59.0% of the patients using opioids, NSAIDs and adjuvant analgesics, respectively. Multivariate regression analyses showed that patients with prior opioid and adjuvant analgesic use were 21% and 5% less likely to discontinue BTDS (P < 0.05), respectively, as compared to patients not using these agents. Patients with concomitant use of adjuvant analgesics were 15% less likely to discontinue therapy (P < 0.05) as compared to patients without concomitant use of these agents. Long-term BTDS persistence was also observed in patients who had a dose change or a last dose strength >5 mcg/hour. Sensitivity analyses for those with 30-day prior opioid use and patients with ≥ 2 claims of BTDS confirmed these findings.. Prior and concomitant use of adjuvant analgesics, prior use of opioids, and dose adjustments were associated with significantly longer persistence among patients initiating BTDS. The results suggest that patients are less likely to discontinue BTDS early if practitioners account for prior treatment history and dose titration.

Topics: Administration, Cutaneous; Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Chronic Pain; Databases, Factual; Drug Therapy, Combination; Female; Humans; Male; Medication Adherence; Middle Aged; Pain Measurement; Time Factors; Transdermal Patch

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Medication Adherence; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Point-of-Care Systems; Sensitivity and Specificity; Substance Abuse Detection; Urinalysis

In some countries, particularly the United States and Canada, there has been a growing problem of opioid dependence associated with the treatment of chronic pain. Controversy exists regarding the efficacy and safety of opioid therapy, particularly in high doses for extended periods of time. This study reports on the outcome of chronic pain patients treated with buprenorphine in an outpatient psychiatric consultation clinic.. Forty three consecutive outpatient clinic chronic pain patients with a DSM-IV diagnosis of opioid dependence and treated with buprenorphine during a 3-year period were monitored for follow-up periods of up to 5 years. All subjects were dependent on drugs prescribed for pain and were divided into two groups: those who had a history of abuse of alcohol or drugs and those who did not Historical, physical, demographic, and outcome data were collected.. The majority of patients were male, not working, and between the ages of 45-60. Follow-up revealed that treatment with buprenorphine was effective. Most patients had improved pain with treatment of the opioid dependence. There were no differences between those with or without a history of substance abuse.. Patients often improved with much less preoccupation with pain, expressing great satisfaction with buprenorphine treatment.. Buprenorphine is an effective tool when treating the opioid-dependent chronic pain patient.

Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Comorbidity; Female; Humans; Male; Middle Aged; Pain Clinics; Patient Satisfaction; Prescription Drug Misuse; Retrospective Studies; Young Adult

Pain and depression are each prevalent among opioid dependent patients receiving maintenance buprenorphine, but their interaction has not been studied in primary care patients.. We set out to examine the relationship between chronic pain, depression, and ongoing substance use, among persons maintained on buprenorphine in primary care settings.. Between September 2012 and December 2013, we interviewed buprenorphine patients at three practice sites.. Opioid dependent persons at two private internal medicine offices and a federally qualified health center participated in the study.. Pain was measured in terms of chronicity, with chronic pain being defined as pain lasting at least 6 months; and in terms of severity, as measured by self-reported pain in the past week, measured on a 0-100 scale. We defined mild chronic pain as pain severity between 0 and 39 and lasting at least 6 months, and moderate/severe chronic pain as severity ≥ 40 and lasting at least 6 months. To assess depression, we used the Center for Epidemiologic Studies Depression (CESD) ten-item symptom scale and the two-item Patient Health Questionnaire (PHQ-2).. Among 328 participants, 169 reported no chronic pain, 56 reported mild chronic pain, and 103 reported moderate/severe chronic pain. Participants with moderate/severe chronic pain commonly used non-opioid pain medications (56.3%) and antidepressants (44.7%), yet also used marijuana, alcohol, or cocaine (40.8%) to help relieve pain. Mean CESD scores were 7.1 (±6.8), 8.3 (±6.0), and 13.6 (±7.6) in the no chronic, mild, and moderate/severe pain groups, respectively. Controlling for covariates, higher CESD scores were associated with a higher likelihood of moderate/severe chronic pain relative to both no chronic pain (OR = 1.09, p < 0.001) and mild chronic pain (OR = 1.06, p = 0.04).. Many buprenorphine patients are receiving over-the-counter or prescribed pain medications, as well as antidepressants, and yet continue to have significant and disabling pain and depressive symptoms. There is a clear need to address the pain-depression nexus in novel ways.

Topics: Adult; Buprenorphine; Chronic Pain; Cross-Sectional Studies; Depression; Diagnosis, Dual (Psychiatry); Employment; Female; Humans; Male; Middle Aged; New England; Opiate Substitution Treatment; Opioid-Related Disorders; Pain Measurement; Primary Health Care; Psychiatric Status Rating Scales

To determine whether the prevailing liquid chromatography and tandem mass spectroscopy assay (LC-MS/MS) assay designed to monitor buprenorphine compliance of the sublingual formulation used in the substance abuse treatment setting can be extrapolated to the transdermal formulation used in the chronic pain treatment setting, which is 1000-fold less concentrated.. Retrospective chart review.. Self-reported compliant patients using the transdermal or sublingual formulations of buprenorhphine. Transdermal patch application was also visually confirmed during clinic visits.. Urine drug test results from a LC-MS/MS were compared between samples from transdermal and sublingual patients.. While all sublingual patients tested positive for at least one metabolite of buprenorphine, only 69% of the transdermal patients did so. In addition, the most abundant metabolite in the transdermal patients was buprenorphine-glucuronide, as compared with norbuprenorphine-glucuronide in sublingual patients.. These data suggest that currently available urine drug tests for buprenorphine, including the more expensive LC-MS/MS based assays, may not be sufficiently sensitive to detect the metabolites from transdermal buprenorphine patients. This study highlights the need to evaluate the value and sensitivity of urine drug tests given the wide range of buprenorphine dosing in clinical practice. These results underscore the need for additional cost benefit analyses comparing different confirmatory drug testing techniques including many commercially available drug testing options. © 2014 Wiley Periodicals, Inc.

Topics: Administration, Cutaneous; Administration, Sublingual; Adult; Analgesics, Opioid; Buprenorphine; Chromatography, Liquid; Chronic Pain; Female; Humans; Male; Middle Aged; Retrospective Studies; Substance Abuse Detection; Substance-Related Disorders; Tandem Mass Spectrometry; Treatment Outcome; Urinalysis

There is general agreement about the need to perform a screening test to assess the risk of opioid misuse prior to starting a long-term opioid treatment for chronic noncancer pain. The evidence supporting the effectiveness of opioid long-term treatment is weak, and no predictors of its usefulness have been assessed.. The aim of this study was to assess the effect on pain and quality of life of chronic opioid treatment, and detect the possible predictors of its effectiveness.. This observational, prospective study was conducted in 2 Italian Pain Relief Units on 77 patients affected by intractable chronic pain. Patients were submitted to psycho-logical tests, investigating the individual pain experience, risk of opioid misuse, mood states, quality of life, and personality characteristics prior to starting treatment and at 2,4, and 6-month follow-up.. Both maximum and habitual pain, as measured with VAS, underwent a statistically significant reduction at 2, 4, and 6-month follow-up. In multivariate analysis, lower scores in the Pain Medication Questionnaire (PMQ) were predictive of a major reduction in maximum VAS (P = 0.005). Both low PMQ and MMPI-cynicism scores were predictive of habitual VAS decrease (P = 0.012 and P = 0.028, respectively).. The results indicate that pain relief significantly improved over a 6-month period of opioid treatment, together with quality of life. The outcome was better in patients with a pretreatment low risk of opioid misuse, low scores in the Cynicism scale of MMPI-2, and no aberrant drug behaviors at follow-up. Therefore, a psychological screening and support is crucial for a good outcome of opioid therapy for chronic noncancer pain patients.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Fentanyl; Humans; Hydromorphone; Longitudinal Studies; Male; Middle Aged; Multivariate Analysis; Opioid-Related Disorders; Oxycodone; Pain Clinics; Pain Measurement; Personality; Phenols; Prospective Studies; Quality of Life; Surveys and Questionnaires; Tapentadol; Treatment Outcome

A patient in my practice who takes buprenorphine for chronic pain would like to conceive. Is it safe for her to continue taking her medication?. The literature regarding periconceptional opioid use is conflicted as to whether opioids pose an elevated risk of birth defects. Confounding factors such as socioeconomic status, stress, and alcohol consumption might play a role. The first trimester of pregnancy is the critical period of development for many organ systems in the embryo. A chemical or environmental insult is more likely to produce major congenital malformations such as neural tube defects or mental retardation if it occurs within this window. Medical practitioners should judiciously consider a risk-benefit analysis before making their decisions.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Contraindications; Female; Fertilization; Humans; Maternal-Fetal Exchange; Pregnancy; Risk Assessment

Pain is a global epidemic, exacerbated by barriers to access of opioid analgesics. Regulations about opioids attempt to protect public health from the risks of harmful use of opioids, diversion, and dependence. Transdermal buprenorphine is an effective opioid analgesic agent with unique properties that may make it particularly well suited for more widespread use. It is a versatile analgesic product with demonstrated safety and effectiveness in cancer and noncancer pain populations. Its pharmacological properties make it a first-line opioid analgesic for geriatric patients and patients with renal dysfunction; no dosing adjustments need to be made. The 7-day transdermal delivery system is convenient for patients and promotes compliance. A low dose of buprenorphine can provide effective and well-tolerated pain relief. Although buprenorphine has been associated with certain opioid-related adverse effects, such as dizziness and nausea, it is associated with a lower rate of constipation than many other opioid analgesics. The potential for nonmedical use of buprenorphine is relatively low compared with other opioid agents. Buprenorphine has a relatively low likeability for nonmedical use and the transdermal matrix patch renders the substance particularly difficult to extract for illicit purposes.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Pain; Cost of Illness; Humans; Opioid-Related Disorders

Chronic pain is common among patients receiving opioid maintenance treatment (OMT) for opioid use disorder. To aid development of treatment recommendations for coexisting pain and opioid use disorder, it is necessary to characterize pain treatment needs and assess whether needs differ as a function of OMT medication.. A point-prevalence survey assessing pain and engagement in coping strategies was administered to 179 methadone and buprenorphine-maintained patients.. Forty-two percent of participants were categorized as having chronic pain. Methadone patients had greater severity of pain relative to buprenorphine patients, though both groups reported high levels of interference with daily activities, and participants with pain attended the emergency room more frequently relative to participants without pain. Only 2 coping strategies were being utilized by more than 50% of participants (over-the-counter medication, prayer).. Results indicate that pain among OMT patients is common, severe, and of significant impairment. Methadone patients reported greater severity pain, particularly worse pain in the past 24h, though interference from pain in daily activities did not vary as a function of OMT. Most participants with pain were utilizing few evidenced-based pain coping strategies. Increasing OMT patient access to additional pain treatment strategies is an opportunity for immediate intervention, and similarities across OMT type suggest interventions do not need to be customized to methadone vs. buprenorphine patients.

Topics: Adaptation, Psychological; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Maintenance Chemotherapy; Male; Methadone; Middle Aged; Opioid-Related Disorders; Pain Management; Pain Threshold; Prevalence

Sublingual buprenorphine, with and without naloxone, is indicated for the treatment of opioid use disorders. Although not approved for pain, some evidence suggests it may be a safe and effective alternative to conventional opioid analgesics, particularly for those with addiction problems. This study surveyed pain specialists to examine the extent to which sublingual buprenorphine was prescribed for chronic pain and explore associated clinician attitudes and characteristics.. A 36-item survey examining clinician attitudes and characteristics related to sublingual buprenorphine and other opioids was distributed to 1307 members of the American Pain Society, a multidisciplinary professional group. Members were provided a paper copy of the survey and URL to an online version. A follow-up letter was mailed after 2 weeks.. Overall, 230 completed surveys were returned (18.5%). Of clinicians who prescribed opioids for chronic pain (92.5%), 19.7% reported prescribing sublingual buprenorphine for chronic pain at least once; of these prescribers, 39.6% did not have a DEA X-waiver to prescribe sublingual buprenorphine for opioid dependence. Prescribers were more likely than nonprescribers to find sublingual buprenorphine effective for chronic pain. Prescribers were also significantly more likely to view sublingual buprenorphine as safer than full agonists in terms of addiction, overdose, and drug interaction. No differences emerged between prescribers and nonprescribers regarding perceptions of potential for drug diversion or in terms of overall opioid prescribing behaviors.. Results suggest that sublingual buprenorphine is indeed being used to treat chronic pain; however, the circumstances when this occurs are not entirely clear.

Topics: Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Health Surveys; Humans; Male; Physicians; Practice Patterns, Physicians'; Prescription Drugs; United States

A recent pharmacokinetic study with buprenorphine transdermal patches showed similar systemic exposures of buprenorphine in subjects aged ≥75 and 50-60 years. The current prospective, open-label study aimed to verify this in a clinical setting by evaluating efficacy and safety of buprenorphine patches in patients with chronic osteoarthritis (OA) pain.. Patients with chronic, moderate to severe osteoarthritic pain (hip and/or knee) were enrolled: 50-60 years (younger group, N = 65) and ≥75 years (elderly group, N = 57). After 2 weeks on paracetamol only, patients received buprenorphine patches (5-40 µg/h) for 12 weeks. Paracetamol rescue was provided. Primary endpoint was the Box-Scale-11 (BS-11) score for pain on average over the last week. WOMAC OA Index, EQ-5D, Patients' and Investigators' Global Assessment of Pain Relief, rescue medication use, sleep disturbance and quality of sleep were secondary efficacy endpoints.. Both groups showed a statistically significant (p < 0.0001) and clinically relevant change from baseline to last visit in BS-11 score, with no significant difference between groups. The least squares (LS) mean change from baseline was 2.20 in elderly and 1.87 in younger patients, with an age group difference of 0.33 (95% CI: -0.42, 1.07). Non-inferiority of the elderly versus the younger group was shown. Both age groups showed a significant improvement in WOMAC total score, patients' overall health state (EQ-5D visual analogue scale) and sleep quality, and a significant reduction in rescue use and nights woken due to pain, with no significant differences between groups. Elderly patients tolerated buprenorphine patches at least as well as younger patients.. Efficacy and tolerability of buprenorphine patches was demonstrated in chronic pain patients, regardless of age, supporting the conclusion that no age-related dose adjustment of transdermal buprenorphine is needed. A study limitation is lack of active control but no other opioid was appropriate in elderly patients or this indication.

Topics: Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Middle Aged; Osteoarthritis; Outcome Assessment, Health Care; Pain Measurement; Prospective Studies; Sleep; Transdermal Patch

Topics: Administration, Oral; Aged; Analgesics, Opioid; Arthroplasty, Replacement, Hip; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Female; Humans; Iatrogenic Disease; Injections, Intramuscular; Long-Term Care; Meperidine; Opioid-Related Disorders; Pain, Postoperative; Patient Admission

Medication prescribing information provides guidance to healthcare providers on how to prescribe a drug properly. Oftentimes patient factors in addition to the prescribing information are considered when selecting medications. Utilizing real-world pharmacy and medical claims data, this study assessed US practitioner prescribing practices of US approved transdermal buprenorphine system (BTDS) in relation to BTDS's full prescribing information (FPI) as well as the relationship between patient factors and initial BTDS dose.. Patients aged ≥18 years initiating BTDS between 1 January 2011 and 30 November 2011 were identified in the IMS Pharmacy and Private Practitioner Medical Claims databases. The index date was defined as the first filled BTDS prescription. Demographics, chronic pain-related medical conditions in the 12 months pre-index and prior medication use in the 6 months pre-index were assessed. Initial BTDS dosing strength, receipt of approved initial BTDS dose per the FPI, and concomitant medications were assessed in the post-index 6 month period.. The study included 10,457 patients newly treated with BTDS. The majority of patients were female (69.9%) with a mean (±SD) age of 54.5 (±15.2) years. Within the 6 months prior to the index BTDS prescription, 91.7% of the patients used opioids. Overall, 48.9% of patients were prescribed the FPI approved BTDS dose. When stratified, 73.5% of opioid-naïve patients received the FPI approved initial dose compared to 46.0% of those with prior opioid experience of ≤80 mg morphine-equivalent daily dose. Patients on BTDS alone (i.e. monotherapy) had a higher rate of receiving the FPI approved initial BTDS dose compared to patients on BTDS concomitant regimens (p < 0.05).. Practitioners demonstrated that they prescribe in accordance with BTDS's prescribing information in the majority of opioid-naïve patients and in approximately half of opioid-experienced patients. The initial opioid dose is a critical step in treatment, setting the stage for preventing side-effects and improving treatment effectiveness. Understanding practitioner prescribing practices with regard to the initial dose selection of BTDS may provide insight on how to improve outcomes of care and reduce healthcare resource utilization and costs associated with pain management.. Data obtained from prescription claims reflect only the activities of prescriptions filled, not medication use or other clinical characteristics observed by physicians when treating patients.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Databases, Factual; Female; Guideline Adherence; Humans; Male; Middle Aged; Practice Guidelines as Topic; Practice Patterns, Physicians'; Retrospective Studies; Transdermal Patch; United States; Young Adult

To evaluate the effectiveness and safety of transdermal buprenorphine (BTDS) in the treatment of post-traumatic pain in a working population.. Retrospective case series of patients with severe post-traumatic pain treated with BTDS between 2008 and 2012.. 57 patients were evaluated: 38 men, 19 women (mean age 43 years); patients with burns (n = 22), skin degloving (14), open dislocations (eight), traumatic nerve lesions (six), spinal cord injury (four) and limb amputations (three). 25, 12 and 20 patients experienced neuropathic pain, nociceptive pain or neuropathic/nociceptive pain, respectively. The mean baseline DN4 questionnaire and pain intensity scores were 4.8±2.3 and 7.4±1.5, respectively. The mean duration of pain before BTDS use was 24.4 months (>3 months in 65% of patients). Total patient-years of BTDS treatment were 73. After 14.7±14.9 months of BTDS treatment, mean pain intensity was reduced by 4.2±2.2 points, 38 patients (66.7%) had ≥50% pain relief, 69% reported functional improvement, especially in gait ability (25) and activities of daily life (14), and 46 patients (80.7%) had improved sleep quality. The starting dose of BTDS was 4.4-17.5 μg/h; maintenance dose was 8.8-70 μg/h. At the start of BTDS treatment, all patients used a total of 187 concomitant analgesics daily, 72% of which were stopped during treatment with BTDS; the number of patients that could be managed exclusively with BTDS and rescue analgesia increased to 31%. 13 patients (22%) presented nausea, eight constipation, six local skin reactions, three vomiting and somnolence, and two patients experienced dizziness. Four patients (6.9%) stopped BTDS due to adverse reactions.. BTDS is an effective and safe alternative for the treatment of patients with severe post-traumatic pain, reducing the intensity of pain and improving functional capacity and quality of sleep.

Topics: Accidents, Occupational; Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pain Measurement; Patient Compliance; Retrospective Studies; Return to Work; Wounds and Injuries; Young Adult

Surveys of current trends indicate heroin abuse is associated with nonmedical use of pain relievers. Consequently, there is an interest in evaluating the presence of heroin-specific markers in chronic pain patients who are prescribed controlled substances. A total of 926,084 urine specimens from chronic pain patients were tested for heroin/diacetylmorphine (DAM), 6-acetylmorphine (6AM), 6-acetylcodeine (6AC), codeine (COD), and morphine (MOR). Heroin and markers were analyzed using liquid chromatography tandem mass spectrometry (LC-MS-MS). Opiates were analyzed following hydrolysis using LC-MS-MS. The prevalence of heroin use was 0.31%, as 2871 were positive for one or more heroin-specific markers including DAM, 6AM, or 6AC (a known contaminant of illicit heroin). Of these, 1884 were additionally tested for the following markers of illicit drug use: 3,4-methylenedioxymethamphetamine (MDMA), 3,4-methylenedioxyamphetamine (MDA), methamphetamine (MAMP), 11-nor-9-carboxy-Δ(9)-tetracannabinol (THCCOOH), and benzoylecgonine (BZE); 654 (34.7%) had positive findings for one or more of these analytes. The overall prevalence of heroin markers were as follows: DAM 1203 (41.9%), 6AM 2570 (89.5%), 6AC 1082 (37.7%). MOR was present in 2194 (76.4%) and absent (

Topics: Analgesics, Opioid; Biomarkers; Buprenorphine; Chromatography, Liquid; Chronic Pain; Codeine; Heroin; Heroin Dependence; Humans; Illicit Drugs; Methadone; Morphine Derivatives; Pain Clinics; Tandem Mass Spectrometry

Buprenorphine is a semisynthetic opioid with both agonist and antagonist activity at the opioid receptor. Currently, buprenorphine is commonly available in sublingual preparations combined with naloxone (e.g., Suboxone®, Subutex®). There has been increased use of buprenorphine derivatives in the areas of substance addiction and chronic pain. Nevertheless, there is limited and conflicting information in the literature pertaining to the optimal management of buprenorphine-stabilized patients presenting for surgery. We present our experience with a chronic pain patient on buprenorphine presenting for thoracic surgery.. A 47-yr-old female with a history of a Clagett window procedure for pulmonary aspergillosis and subsequent chronic pain presented to our institute for a window closure procedure. Preoperatively, her pain regimen included Suboxone 16 mg bid, which was continued perioperatively. Postoperatively, her course was complicated by suboptimal pain at the surgical site requiring in excess of 70 mg/24 hr of intravenous hydromorphone. Liberal addition of long-acting oral opioids was ineffective in improving pain management. Eventually, concern was raised regarding opioid receptor blockade by her long-acting Suboxone, and the decision was made to taper her Suboxone. Following this, her pain control improved dramatically and her opioid requirements were markedly reduced. By discharge, her Suboxone was discontinued and she was managed on oral hydromorphone.. In a chronic pain patient continued on Suboxone perioperatively, significant improvement in control of postoperative pain was observed following tapered doses, and eventually her use of Suboxone was discontinued. This case highlights the potential for opioid receptor blockade by Suboxone, which can interfere with acute pain management.

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Female; Humans; Middle Aged; Naloxone; Pain, Postoperative; Pulmonary Aspergillosis; Thoracic Surgical Procedures

The very strong relationship between suicide, depressive disorders, and substance use disorders is well recognized. Certain pain syndromes are significantly associated with suicide, irrespective of co-occurring medical or psychiatric diagnosis. Chronic pain, depression, substance use disorders, and suicide appear to involve overlapping neural pathways and brain regions that function in the processing of emotional and physical pain, as well as maintaining reward and anti-reward circuitry. In this article, we employ a clinical case to illustrate how various stressors disrupted the balance between pain and opioid-facilitated analgesia. This disruption resulted in excessive use of short-acting opioids to treat pain with ensuing allostatic overload and culmination in chronic suicidal ideation with a suicide attempt. Sublingual buprenorphine was selected to treat the opioid use disorder. We propose that the unique pharmacodynamics of this drug served to stabilize dysregulated neural circuits, neurotransmitters, and neuropeptides, allowing the mitigation of pain, assuaging opioid cravings, easing depression, and resolving suicidal ideation. To our knowledge, this is the first case report to describe the possible anti-suicidal effect of sublingual buprenorphine.

Topics: Administration, Sublingual; Allosteric Regulation; Analgesics, Opioid; Brain; Buprenorphine; Chronic Pain; Comorbidity; Depressive Disorder, Treatment-Resistant; Drug Interactions; Female; Humans; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Substance Abuse Treatment Centers; Suicidal Ideation; Suicide; Suicide Prevention; Suicide, Attempted

This study aims to determine the effectiveness of converting patients from high doses of full-opioid agonists to sublingual (SL) buprenorphine.. An observational report of outcomes assessment.. An interventional pain management practice setting in the United States.. Thirty-five chronic pain patients (age 24-66) were previously treated with high-dose opioid-agonist drugs and converted to SL buprenorphine. Patients' daily morphine equivalents ranged from 200 mg to 1,370 mg preconversion, with a mean daily dose of 550 mg.. A retrospective chart analysis examined numerical pain levels and quality of life scores before and 2 months after conversion to SL buprenorphine.. After continuation of SL buprenorphine therapy for 2 months, the mean pain score decreased from 7.2 to 3.5 (P < 0.001), with 34 of the 35 patients examined reporting a decrease in pain. This pain score decrease was robust with regard to initial pain score and preconversion morphine equivalent dosage. Quality of life scores improved from 6.1 to 7.1 (P = 0.005).. Average pain scores decreased from 7.2 to 3.5, and quality of life scores increased from 6.1 to 7.1 for 35 patients converted from high-dose full-opioid agonists to SL buprenorphine therapy for more than 60 days. Clinicians should consider buprenorphine SL conversion for all patients on high-dose opioids, particularly patients with severe pain (7-10) unrelieved by their current opioid regimen or patients for whom the clinician does not feel comfortable prescribing high-dose opioids.

Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Middle Aged; Opiate Substitution Treatment; Pain Management; Quality of Life; Young Adult

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Transdermal Patch

To characterize the profile of application site reactions (ASRs) for patients treated with the buprenorphine transdermal system (BTDS) in chronic pain studies.. The incidences of ASRs during treatment with BTDS were examined using (a) integrated data from 16 controlled and uncontrolled Phase III chronic pain studies (N = 6566), (b) a subset of integrated data that focused on the double-blind phases of five enriched, placebo-controlled studies (n = 1806) and (c) data from an international postmarketing drug safety database. These data were compared with the ASR data reported in the full prescribing information of other transdermal patches marketed in the US.. Among the 6566 patients, the overall incidence of ASRs was 23.4%, of which 98.3% were mild to moderate in intensity, none were serious and 4.4% led to treatment discontinuation. Rates of severe and inflammatory ASRs were low. Among the 1806 patients, ASR rates were higher with BTDS (16.6%) than placebo transdermal system (12.7%). Among the 6566 patients, the 1806 patients, and the postmarketing data, the most common ASRs seen were pruritus, erythema and rash. Incidences of most ASRs for other selected transdermal products were 17% or lower.. Incidence rates of ASRs in patients treated with BTDS were low and infrequently led to discontinuation. Severe and inflammatory-type ASRs were not common. The ASR profile of BTDS was comparable with those of other transdermal patches.

Topics: Administration, Cutaneous; Aged; Buprenorphine; Chronic Pain; Clinical Trials, Phase III as Topic; Dermatitis, Allergic Contact; Double-Blind Method; Female; Humans; Male; Middle Aged; Transdermal Patch

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Hyperalgesia

Few studies have examined abuse of prescription opioids among individuals with chronic pain under buprenorphine/naloxone (Bup/Nx) maintenance. The current 7-week inpatient study assessed oral oxycodone self-administration by patients with chronic pain who had a history of opioid abuse. Participants (n=25) were transitioned from their preadmission prescribed opioid to Bup/Nx. All of the participants were tested under each of the sublingual Bup/Nx maintenance doses (2/0.5, 8/2 or 16/4 mg) in random order. During each maintenance period, participants could self-administer oxycodone orally (0, 10, 20, 40 or 60 mg prescription opioids) or receive money during laboratory sessions. Drug choice (percentage) was the primary dependent variable. Subjective ratings of clinical pain and withdrawal symptoms also were measured. Mann-Whitney tests compared percentage of drug choice for each active oxycodone dose to placebo. Logistic regression analyses identified correlates of oxycodone preference, defined as 60% or greater choice of oxycodone compared to money. Pain was significantly reduced while participants were maintained on Bup/Nx compared to preadmission ratings. No differences in percentage drug choice were observed between the active oxycodone doses and placebo under each Bup/Nx maintenance dose. However, factors associated with oxycodone preference were lower Bup/Nx maintenance dose, more withdrawal symptoms and more pain. These data suggest that Bup/Nx was effective in reducing pain and supplemental oxycodone use. Importantly, adequate management of pain and withdrawal symptoms by Bup/Nx may reduce oxycodone preference in this population.

Topics: Administration, Oral; Adult; Analgesics, Opioid; Buprenorphine; Chronic Pain; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Oxycodone; Statistics, Nonparametric

Buprenorphine is a chemically synthesized opioid characterized as the partial mu agonist and kappa antagonist, and transdermal buprenorphine patch will be considered useful as a strong analgesic with fewer psychological side effects in the treatment of chronic non-cancer pain. Use of transdermal buprenorphine should be limited for pain relief of intractable muscle skeletal pain that cannot be alleviated with other analgesics. To avoid severe complication and drug abuse or addiction, assessment of pain and medical history including drug dependence by medical team are important before administration of transdermal buprenorphine. Moreover, side effects such as nausea, vomiting, constipation, erythema and itching, loss of appetite should be treated appropriately. When transdermal buprenorphine is administered to chronic pain patients, physicians must examine the condition of patients regularly at an outpatient clinic. Moreover, decreasing and discontinuation of opioid including transdermal buprenorphine should always be considered during the treatment. Most important objective of chronic pain treatment is to improve QOL and ADL of patients.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Pain, Intractable; Transdermal Patch

Questions from patients about pain conditions, analgesic pharmacotherapy and responses from authors are presented to help educate patients and make them more effective self-advocates. The use of transdermal buprenorphine for chronic pain management is discussed. A brief history of the medication is provided. The use of the medication in opioid maintenance, and withdrawal and other concerns are discussed. Possible side effects are described.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Pain; Humans; Opiate Substitution Treatment; Opioid-Related Disorders; Transdermal Patch

Six-months analysis of non-interventionally collected observation data of effectiveness of long-term treatment with low-dose 7-day buprenorphine transdermal patch in elderly patients with chronic pain.. Analysis of data regarding pain intensity, pain-related impairments of daily life and quality of life documented by 321 pain patients in German primary care (age 72.4 +/- 13.8 years; 67.3% female; musculoskeletal pain 85.4%; mean pain intensity 6.1 +/- 1.2, for 90% > or = 5 NRS11) using standardised self-report instruments (German Pain Questionnaire/German Pain Diary).. After initiation with 5/10 microg/h buprenorphine (89.7%/10.3%), treatment was maintained in 57.1/39.1/3.8% patients with stable doses of 5/10/20 microg/h after 6 months. The average pain intensity decreased by 5.1 +/- 1.0 (absolute) to 1.0 +/- 1.0 NRS11 (83.5%), pain-related impairments and burden of pain were reduced by 86.0% and 87.9%, respectively, and pain-related quality of life improved by 97.3% to nearly normalvalues.. Pain treatment of elderly persons with 7-day low-dose transdermal buprenorphine patch on a stable dose regimen resulted in fast, effective and sustained pain relief accompanied by marked improvements in daily life participation and quality of life.

Topics: Activities of Daily Living; Aged; Aged, 80 and over; Anxiety; Buprenorphine; Chronic Pain; Depression; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Pain Measurement; Quality of Life; Transdermal Patch

Recently, low-dose transdermal buprenorphine (LD-TD-BUP) was introduced for treatment of patients with chronic non-malignant pain. The primary aim of this study was to determine the proportion of patients who were prescribed LD-TD-BUP for non-malignant pain who became long-term users. The secondary aim was to determine the proportion of patients who co-medicated with other opioids or benzodiazepines during treatment with LD-TD-BUP.. Data were drawn from the Norwegian Prescription Database that covers all prescriptions dispensed at pharmacies to the entire Norwegian population (4.7 million inhabitants). The study population consisted of all patients who were dispensed at least one prescription of LD-TD-BUP from its introduction in November 2005 to 31 December 2008. Patients who were dispensed more than 24 patches (≥ 6 months) were defined as long-term users. Reimbursement codes were used to stratify patients as having cancer pain or non-malignant pain.. Among new users of LD-TD-BUP for non-malignant pain (n = 13,451), only 22% became long-term users, while 44% were only dispensed one prescription. Among long-term users who were opioid naive when LD-TD-BUP was initiated, 43% co-medicated with other opioids or benzodiazepines, compared with 82% of those who previously had used opioids.. Three years after introduction, 0.4% of the Norwegian population had been dispensed LD-TD-BUP. Only one-fifth had become long-term users. Those who used opioids before the first dispension of LD-TD-BUP co-medicated with other potentially addictive drugs to a much higher degree compared with those who were opioid naive.

Topics: Administration, Cutaneous; Adult; Age Factors; Aged; Aged, 80 and over; Buprenorphine; Chronic Pain; Databases, Factual; Drug Prescriptions; Drug Therapy, Combination; Drug Utilization; Female; Humans; Hypnotics and Sedatives; Long-Term Care; Male; Middle Aged; Narcotics; Norway; Opioid-Related Disorders; Retrospective Studies; Young Adult

Urine buprenorphine screening is utilized to assess buprenorphine compliance and to detect illicit use. Robust screening assays should be specific for buprenorphine without cross-reactivity with other opioids, which are frequently present in patients treated for opioid addiction and chronic pain. We evaluated the new Lin-Zhi urine buprenorphine enzyme immunoassay (EIA) as a potentially more specific alternative to the Microgenics cloned enzyme donor immunoassay (CEDIA) by using 149 urines originating from patients treated for chronic pain and opioid addiction. The EIA methodology offered specific detection of buprenorphine use (100%) (106/106) and provided superior overall agreement with liquid chromatography-tandem mass spectrometry, 95% (142/149) and 91% (135/149) using 5 ng/mL (EIA[5]) and 10 ng/mL (EIA[10]) cutoffs, respectively, compared to CEDIA, 79% (117/149). CEDIA generated 27 false positives, most of which were observed in patients positive for other opioids, providing an overall specificity of 75% (79/106). CEDIA also demonstrated interference from structurally unrelated drugs, chloroquine and hydroxychloroquine. CEDIA and EIA[5] yielded similar sensitivities, both detecting 96% (22/23) of positive samples from patients prescribed buprenorphine, and 88% (38/43) and 81% (35/43), respectively, of all positive samples (illicit and prescribed users). The EIA methodology provides highly specific and sensitive detection of buprenorphine use, without the potential for opioid cross-reactivity.

Topics: Buprenorphine; Chromatography, High Pressure Liquid; Chronic Pain; Forensic Toxicology; Humans; Immunoenzyme Techniques; Narcotics; Reproducibility of Results; Sensitivity and Specificity; Substance Abuse Detection; Substance-Related Disorders; Tandem Mass Spectrometry

Sublingual buprenorphine-naloxone (buprenorphine SL) is a preparation that is used to treat opioid dependence. In addition, the Drug Enforcement Administration (DEA) has acknowledged the legality of an off-label use to treat pain with a sublingual buprenorphine preparation. Buprenorphine SL is unique among the opioid class of analgesics; this compound has a high affinity for the mu-receptor, yet only partially activates it. Thus, buprenorphine SL can provide analgesia, yet minimize opioid side effects. Many patients on high doses of traditional opioid medication develop tolerance. Despite escalating medication dosage, a subset of patients had a paradoxical increase in pain, which has been characterized as opioid-induced hyperalgesia (OIH).  Buprenorphine SL, on the other hand, may even be anti-hyperalgesic and may have utility in treating these challenging patients.. To determine the effectiveness of converting patients from traditional full agonist opioid medication to sublingual buprenorphine, as well as to identify patient groups that are most likely to benefit from this therapy. Patients who underwent conversion either had developed tolerance with diminished analgesia or were experiencing side effects on their opioid medications.. An observational report of outcomes assessment.. An interventional pain management practice setting in the United States.. Retrospective data from clinical records was compiled on 104 de-identified chronic pain patients whose personal information had been redacted (60 men and 44 women, aged 21-78) and who had previously been treated with opioid-agonist drugs; they were converted to buprenorphine SL in tablet form during the study. Chronic pain was defined as persistent pain for at least 6 months. Data collected from patient profiles included age, sex, diagnosis, medication history, pre-induction opioid intake, reason for detoxification, pre-induction Clinical Opiate Withdrawal Score (COWS), and if applicable, cause of buprenorphine SL cessation. Pain levels and Quality of Life scores were recorded before and after conversion to buprenorphine SL.. Level of analgesia for patients who continued conversion to sublingual buprenorphine for more than 2 months.. After initiation of buprenorphine SL therapy for more than 2 months, the mean pain scores on a scale from 0-10 decreased by 2.3 points (P < 0.001). Patient Quality of Life (QoL scale) was not significantly affected by buprenorphine SL therapy (P = 0.14). The success rate was highest for patients using morphine, oxycodone, and fentanyl before buprenorphine SL induction. These patient groups had a 3.7 point decrease in pain for those taking morphine, a 2.5 point decrease in pain for those taking oxycodone, and a 2.2 point decrease for those taking fentanyl. The smallest pain reduction was seen in the patient group using oxymorphone before conversion with a 1.1 point decrease in pain. Patients taking between 100-199 mg morphine equivalent per day experienced the greatest reduction (2.7 points) in pain scores. Patients taking between 200 and 299 mg morphine equivalent before buprenorphine SL induction exhibited a decrease of over 2 points on average. Patients taking > 400 mg morphine equivalent reported the smallest reduction in pain scores, on average a 1.1 point decrease.. This study is limited by its observational nature.. Patients continuing buprenorphine SL therapy for more than 60 days reported significant decreases in pain (2.3 points). Patients on doses of opioid medication between 100-199 mg morphine equivalents seemed to fare better with conversion to buprenorphine SL than patients on the highest doses (> 400 mg morphine equivalents). The opioid drug used by the patient before buprenorphine SL induction appears to have some effect on buprenorphine SL conversion success. Patients previously taking morphine, oxycodone, and fentanyl had the greatest decrease in pain after conversion to buprenorphine SL.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Retrospective Studies; Young Adult

Abuse of opioids has become a public health crisis. The historic separation between the addiction and pain communities and a lack of training in medical education have made treatment difficult to provide, especially in primary care. The Co-occurring Disorders Clinic (COD) was established to treat patients with co-morbid chronic pain and addiction. This retrospective chart review reports results of a quality improvement project using buprenorphine/naloxone to treat co-occurring chronic non-cancer pain (CNCP) and opioid dependence in a primary care setting. Data were collected for 143 patients who were induced with buprenorphine/naloxone (BUP/NLX) between June 2009 and November 2011. Ninety-three patients (65%) continued to be maintained on the medication and seven completed treatment and were no longer taking any opioid (5%). Pain scores showed a modest, but statistically significant improvement on BUP/NLX, which was contrary to our expectations and may be an important factor in treatment retention for this challenging population.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Female; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Pain Measurement; Prescription Drugs; Primary Health Care; Quality Improvement; Retrospective Studies; Treatment Outcome

Previous studies have not examined patterns of pain treatment use among patients seeking office-based buprenorphine-naloxone treatment (BNT) for opioid dependence.. To examine, among individuals with pain seeking BNT for opioid dependence, the use of pain treatment modalities, perceived efficacy of prior pain treatment, and interest in pursuing pain treatment while in BNT.. A total of 244 patients seeking office-based BNT for opioid dependence completed measures of demographics, pain status (ie, "chronic pain (CP)" [pain lasting at least 3 months] vs "some pain (SP)" [pain in the past week not meeting the duration criteria for chronic pain]), pain treatment use, perceived efficacy of prior pain treatment, and interest in receiving pain treatment while in BNT.. In comparison with the SP group (N = 87), the CP group (N = 88) was more likely to report past-week medical use of opioid medication (adjusted odds ratio [AOR] = 3.2; 95% CI, 1.2-8.4), lifetime medical use of nonopioid prescribed medication (AOR = 2.2; 95% CI, 1.1-4.7), and lifetime use of prayer (AOR = 2.8; 95% CI, 1.2-6.5) and was less likely to report lifetime use of yoga (AOR = 0.2; 95% CI, 0.1-0.7) to treat pain. Although the 2 pain groups did not differ on levels of perceived efficacy of prior lifetime pain treatments, in comparison with the SP group, the CP group was more likely to report interest in receiving pain treatment while in BNT (P < 0.001).. Individuals with pain seeking BNT for opioid dependence report a wide range of conventional, complementary, and alternative pain-related treatments and are interested (especially those with CP) in receiving pain management services along with BNT.

Topics: Adult; Analgesics; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Combined Modality Therapy; Comorbidity; Complementary Therapies; Female; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Primary Health Care; Treatment Outcome; Utilization Review

Chronic pain is a common problem in clinical practice and women are affected more often than men. Morphine is often used for long-term pain relief, but it induces side effects including endocrine alterations. The aim of the present study was to assess the behavioural and hormonal effects of transdermal buprenorphine in women suffering from persistent non-malignant pain. Hormones (LH, FSH, total and free testosterone, estradiol, cortisol) and pain measures (visual analogue scale, McGill Pain questionnaire, present pain intensity test) were evaluated at baseline and after 1, 3 and 6 months. Subjects were recruited in the Second University of Naples Pain Research Centre. Eighteen chronic pain women were included in the study, divided into pre- and post-menopausal groups. A transdermal buprenorphine patch (Buprenorphine TDS, 35 µg/h) was administered every 72 h. As expected, buprenorphine administration led to a decrease in pain intensity and no side effects suggestive of hypogonadism were recorded. Pain measures decreased at the first control visit (T1) in both groups. Total and free testosterone were not reduced by treatment (they tended to increase in both groups) while cortisol progressively recovered from the quite low levels detected at the beginning of treatment. These data confirm that buprenorphine is a safe and effective drug for pain relief in women. It is free from the adverse effects on gonadal hormones frequently associated with other opioid treatments. The lack of opioid-induced effects on gonadal hormones (i.e., hypogonadism) is important to guarantee safe long-term pain treatment.

Topics: Administration, Cutaneous; Adult; Aged; Buprenorphine; Chronic Pain; Female; Humans; Hydrocortisone; Middle Aged; Opiate Substitution Treatment; Postmenopause; Premenopause; Prospective Studies; Testosterone