buprenorphine--naloxone-drug-combination and Substance-Withdrawal-Syndrome

buprenorphine--naloxone-drug-combination has been researched along with Substance-Withdrawal-Syndrome* in 40 studies

Reviews

4 review(s) available for buprenorphine--naloxone-drug-combination and Substance-Withdrawal-Syndrome

ArticleYear
New-Onset Psychotic Symptoms Following Abrupt Buprenorphine/Naloxone Discontinuation in a Female Patient with Bipolar Disorder: A Case Report.
    Psychopharmacology bulletin, 2022, 06-27, Volume: 52, Issue:3

    Buprenorphine and naloxone (Suboxone) is a combination medication-assisted treatment (MAT) for opioid use disorder. MAT withdrawal-induced psychosis is a rare clinical presentation. To our best knowledge, only three reports have summarized the characteristic manifestations of buprenorphine withdrawal psychosis, yet all of them were male. In this case report, we present a 41-year-old female patient with bipolar disorder and comorbid substance use disorder who developed new-onset psychosis and relapse of manic symptoms following abrupt discontinuation of Suboxone. Manic and psychotic symptoms remitted after a short-term hospitalization with the treatment of an antipsychotic and a mood stabilizer. In addition to discussing this case presentation and treatment approach, we review existing literature and discuss possible underlying mechanisms to enhance understanding of this clinical phenomenon.

    Topics: Adult; Antipsychotic Agents; Bipolar Disorder; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Humans; Male; Naloxone; Psychotic Disorders; Substance Withdrawal Syndrome

2022
The perioperative patient on buprenorphine: a systematic review of perioperative management strategies and patient outcomes.
    Canadian journal of anaesthesia = Journal canadien d'anesthesie, 2019, Volume: 66, Issue:2

    An increasing number of patients with opioid use disorder (OUD) are treated with opioid agonist-antagonists such as buprenorphine/naloxone. Perioperative management of patients on buprenorphine/naloxone is inconsistent and remains a controversial topic with mismanagement posing a significant risk to the long-term health of these patients.. We performed a systematic literature search involving Medline, Medline In-Process, Embase, Cochrane Central, Cochrane Database of Systematic Reviews, PsycINFO, Web of Science (Clarivate), Scopus (Elsevier), CINAHL (EbscoHosst), and PubMed (NLM).. Eighteen studies were included in the final sample, including one controlled study and four observational studies . Neither the controlled study nor the observational studies assessed addiction treatment retention, harm reduction, or long-term mortality rates as primary or secondary outcomes. Of the observational studies, authors showed equivalent peri- and postoperative pain control among buprenorphine continued patients. All but one authors described adequate analgesia among the case reports in which buprenorphine ≤ 16 mg sublingually (SL) daily was continued during the perioperative period. Long-term harm reduction was not reported with only three case reports including any long-term abstinence or relapse rates.. The current understanding of the risks and benefits of continuing or stopping buprenorphine perioperatively is limited by a lack of high-quality evidence. Observational studies and case reports indicate no evidence against continuing buprenorphine perioperatively, especially when the dose is < 16 mg SL daily. In patients with significant potential for relapse, such as those with a recent history of OUD, the discontinuation of buprenorphine should have a strong rationale supported by patient and surgical preferences. Future studies require standardized reporting of median doses, details on the route of delivery, dosing schedules and any dosing changes, and rates of addiction relapse, including long-term morbidity and mortality where possible.. RéSUMé: CONTEXTE: Un nombre croissant de patients présentant un trouble d’utilisation des opioïdes (TUO) sont traités avec des agonistes/antagonistes des opioïdes, tels que la buprénorphine et la naloxone. La gestion périopératoire des patients sous buprénorphine/naloxone n’est pas constante et reste un sujet de controverses; de plus une mauvaise gestion pose un risque significatif pour la santé à long terme de ces patients. MéTHODES: Nous avons effectué une recherche systématique de la littérature dans les bases de données suivantes : Medline, Medline In-Process, Embase, Cochrane Central, Cochrane Database of Systematic Reviews, PsycINFO, Web of Science (Clarivate), Scopus (Elsevier), CINAHL (EbscoHosst) et PubMed (NLM). RéSULTATS: Dix-huit études ont été incluses dans l’échantillon final, y compris une étude contrôlée et quatre études observationnelles. Ni l’étude contrôlée ni les études observationnelles n’ont évalué la continuation du traitement de l’addiction, la réduction des préjudices infligés ou les taux de mortalité à long terme parmi les critères d’évaluation principaux ou secondaires. Dans les études observationnelles, les auteurs ont montré qu’il y avait un contrôle équivalent de la douleur en péri- et postopératoire chez les patients continuant à recevoir de la buprénorphine. Tous les auteurs sauf un ont décrit une analgésie satisfaisante dans les rapports de cas où la buprénorphine sublinguale avec une dose ≤ 16 mg par jour était maintenue pendant la période périopératoire. La réduction des préjudices à long terme n’était pas décrite; seulement trois rapports de cas indiquaient le taux d’abstinence à long terme ou les taux de rechute. CONCLUSIONS: Les connaissances actuelles des risques et avantages de la poursuite ou de l’arrêt de la buprénorphine en période périopératoire sont limitées par le manque de données probantes de grande qualité. Les études observationnelles et les rapports de cas ne fournissent pas de données probantes à l’encontre de la poursuite de la buprénorphine dans la période périopératoire, en particulier quand la dose journalière par voie sublinguale est < 16 mg. Chez les patients présentant un risque significatif de rechute, comme ceux ayant des antécédents récents de TUO, l’arrêt de la buprénorphine devrait être solidement justifié avec le soutien des préférences des patients et des équipes chirurgicales. Les futures études nécessitent une normalisation du rapport des doses médianes, des détails sur les voies d’admini

    Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Humans; Perioperative Care; Substance Withdrawal Syndrome; Treatment Outcome

2019
Caring for patients with opioid use disorder in the hospital.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2016, Dec-06, Volume: 188, Issue:17-18

    Topics: Acute Pain; Analgesics, Non-Narcotic; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Overdose; Hospitalization; Humans; Methadone; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Respiration, Artificial; Substance Withdrawal Syndrome

2016
Acute pain management in opioid-tolerant patients: a growing challenge.
    Anaesthesia and intensive care, 2011, Volume: 39, Issue:5

    In Australia and New Zealand, in parallel with other developed countries, the number of patients prescribed opioids on a long-term basis has grown rapidly over the last decade. The burden of chronic pain is more widely recognised and there has been an increase in the use of opioids for both cancer and non-cancer indications. While the prevalence of illicit opioid use has remained relatively stable, the diversion and abuse of prescription opioids has escalated, as has the number of individuals receiving methadone or buprenorphine pharmacotherapy for opioid addiction. As a result, the proportion of opioid-tolerant patients requiring acute pain management has increased, often presenting clinicians with greater challenges than those faced when treating the opioid-naïve. Treatment aims include effective relief of acute pain, prevention of drug withdrawal, assistance with any related social, psychiatric and behavioural issues, and ensuring continuity of long-term care. Pharmacological approaches incorporate the continuation of usual medications (or equivalent), short-term use of sometimes much higher than average doses of additional opioid, and prescription of non-opioid and adjuvant drugs, aiming to improve pain relief and attenuate opioid tolerance and/or opioid-induced hyperalgesia. Discharge planning should commence at an early stage and may involve the use of a 'Reverse Pain Ladder' aiming to limit duration of additional opioid use. Legislative requirements may restrict which drugs can be prescribed at the time of hospital discharge. At all stages, there should be appropriate and regular consultation and liaison with the patient, other treating teams and specialist services.

    Topics: Acute Disease; Analgesics; Analgesics, Opioid; Animals; Australia; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Tolerance; Humans; Hyperalgesia; Illicit Drugs; Methadone; Naloxone; Narcotic Antagonists; Narcotics; New Zealand; Opiate Substitution Treatment; Opioid-Related Disorders; Pain; Pain, Postoperative; Patient Discharge; Preoperative Care; Substance Withdrawal Syndrome

2011

Trials

10 trial(s) available for buprenorphine--naloxone-drug-combination and Substance-Withdrawal-Syndrome

ArticleYear
Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study.
    Journal of substance use and addiction treatment, 2023, Volume: 149

    Conflictual evidence exists regarding the effects of cannabis use on the outcomes of opioid agonist therapy (OAT). In this exploratory analysis, we examined the effect of recent cannabis use on opioid use, craving, and withdrawal symptoms, in individuals participating in a trial comparing flexible buprenorphine/naloxone (BUP/NX) take-home dosing model to witnessed ingestion of methadone.. We analyzed data from a multi-centric, pragmatic, 24-week, open label, randomized controlled trial in individuals with prescription-type opioid use disorder (n = 272), randomly assigned to BUP/NX (n = 138) or methadone (n = 134). The study measured last week cannabis and opioid use via timeline-follow back, recorded at baseline and every two weeks during the study. Craving symptoms were measured using the Brief Substance Craving Scale at baseline, and weeks 2, 6, 10, 14, 18 and 22. The study measured opioid withdrawal symptoms via Clinical Opiate Withdrawal Scale at treatment initiation and weeks 2, 4, and 6.. The mean maximum dose taken during the study was 17.3 mg/day (range = 0.5-32 mg/day) for BUP/NX group and 67.7 mg/day (range = 10-170 mg/day) in the methadone group. Repeated measures generalized linear mixed models demonstrated that cannabis use in the last week (mean of 2.3 days) was not significantly associated with last week opioid use (aβ ± standard error (SE) = -0.06 ± 0.04; p = 0.15), craving (aβ ± SE = -0.05 ± 0.08, p = 0.49), or withdrawal symptoms (aβ ± SE = 0.09 ± 0.1, p = 0.36). Bayes factor (BF) for each of the tested models supported the null hypothesis (BF < 0.3).. The current study did not demonstrate a statistically significant effect of cannabis use on outcomes of interest in the context of a pragmatic randomized-controlled trial. These findings replicated previous results reporting no effect of cannabis use on opioid-related outcomes.

    Topics: Analgesics, Opioid; Bayes Theorem; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cannabis; Humans; Methadone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome

2023
Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: protocol for an open-label, parallel-group, superiority, randomized controlled trial.
    Addiction science & clinical practice, 2021, 02-12, Volume: 16, Issue:1

    Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD). The standard induction method of buprenorphine/naloxone requires patients to be abstinent from opioids and therefore experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of buprenorphine/naloxone and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone in patients with OUD.. This is a randomized, open-label, two-arm, superiority, controlled trial comparing the safety and effectiveness of rapid micro-induction versus standard induction of buprenorphine/naloxone for the treatment of OUD. A total of 50 participants with OUD will be randomized at one Canadian hospital. The primary outcome is the completion of buprenorphine/naloxone induction with low levels of withdrawal. Secondary outcomes are treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction.. This is the first randomized controlled trial to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone. This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis. Trial registration ClinicalTrials.gov, NCT04234191; date of registration: January 21, 2020; https://clinicaltrials.gov/ct2/show/NCT04234191.

    Topics: Adult; British Columbia; Buprenorphine, Naloxone Drug Combination; Female; Humans; Hydromorphone; Male; Opiate Substitution Treatment; Opioid-Related Disorders; Randomized Controlled Trials as Topic; Research Design; Substance Withdrawal Syndrome

2021
Buprenorphine/naloxone versus methadone and lofexidine in community stabilisation and detoxification: A randomised controlled trial of low dose short-term opiate-dependent individuals.
    Journal of psychopharmacology (Oxford, England), 2017, Volume: 31, Issue:8

    Buprenorphine/naloxone, methadone and lofexidine are medications with utility in the treatment of opiate withdrawal. We report the first randomised controlled trial to compare the effects of these two medications on withdrawal symptoms and outcome during opiate induction/stabilisation and detoxification. A double-blind randomised controlled trial was conducted in an outpatient satellite clinic of a specialist drug service. Eighty opiate dependent individuals meeting DSM-IV criteria for opiate dependence, using ⩽ ½ g heroin smoked/chased or ¼ g heroin injected or ⩽ 30mg methadone, with ⩽ 3 years of opioid dependency, underwent a short-term opiate treatment programme involving induction/stabilisation on methadone 30mg or buprenorphine/naloxone 4mg/1mg, followed by detoxification (where the methadone group was assisted by lofexidine). The main outcome measures were urine drug screens for opiates and withdrawal and craving questionnaires. There were no overall differences in positive urine drug screens and drop-outs during any phase of the study. During induction/stabilisation, withdrawal symptoms subsided more slowly for buprenorphine/naloxone than for methadone, and craving was significantly higher in the buprenorphine/naloxone group ( p<0.05, 95% confidence interval -3.5, -0.38). During detoxification, withdrawal symptoms were significantly greater and the peak of withdrawal was earlier for the methadone/lofexidine group than the buprenorphine/naloxone group ( p<0.01, 95% confidence interval 3.0, 8.3). Methadone/lofexidine and buprenorphine/naloxone had comparable outcomes during rapid outpatient stabilisation and detoxification in low dose opiate users.

    Topics: Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Clonidine; Craving; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Methadone; Narcotic Antagonists; Opioid-Related Disorders; Substance Withdrawal Syndrome; Treatment Outcome; Young Adult

2017
Intranasal buprenorphine alone and in combination with naloxone: Abuse liability and reinforcing efficacy in physically dependent opioid abusers.
    Drug and alcohol dependence, 2016, May-01, Volume: 162

    Buprenorphine can be abused by the intranasal route. This study sought to examine the relative abuse liability and reinforcing efficacy of intranasal buprenorphine compared to intranasal buprenorphine/naloxone in opioid-dependent individuals.. Eleven healthy male and female volunteers physically dependent on short-acting opioids resided as inpatients during participation in this double blind, within subject, placebo-controlled study. Participants were maintained on oxycodone (30 mg/q.i.d., p.o.) throughout the 6-week study. Eight pairs of experimental sessions were conducted at ≥48 h intervals to examine the pharmacodynamic profile (Sample) and reinforcing efficacy (Self-administration the following day) of intranasal placebo, oxycodone (60 mg), buprenorphine (2, 8 & 16 mg) and buprenorphine/naloxone (2/0.5, 8/2 & 16/4 mg). Subjective, observer-rated and physiological measures were collected to assess the magnitude of opioid agonist and antagonist effects. A progressive ratio self-administration procedure assessed choices for drug versus money.. All active doses produced opioid agonist-like effects (e.g., increased ratings of "liking," and miosis) compared to placebo. The effects of buprenorphine and buprenorphine/naloxone were not reliably dose-dependent. Intranasal buprenorphine/naloxone elicited modest and transient opioid withdrawal-like effects in the first hour post-drug administration, while simultaneously blunting or blocking the early onset of agonist effects seen with buprenorphine alone. All active doses of buprenorphine were self-administered more than placebo, but buprenorphine/naloxone doses were not.. These data confirm that intranasal buprenorphine/naloxone has deterrent properties related to transient withdrawal effects that likely decrease its desirability for misuse compared to buprenorphine in opioid-dependent individuals maintained on short-acting opioids.

    Topics: Administration, Intranasal; Adolescent; Adult; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Oxycodone; Reinforcement, Psychology; Self Administration; Substance Withdrawal Syndrome; Young Adult

2016
Effect of steady-state faldaprevir on the pharmacokinetics of steady-state methadone and buprenorphine-naloxone in subjects receiving stable addiction management therapy.
    Antimicrobial agents and chemotherapy, 2015, Volume: 59, Issue:1

    The effects of steady-state faldaprevir on the safety, pharmacokinetics, and pharmacodynamics of steady-state methadone and buprenorphine-naloxone were assessed in 34 healthy male and female subjects receiving stable addiction management therapy. Subjects continued receiving a stable oral dose of either methadone (up to a maximum dose of 180 mg per day) or buprenorphine-naloxone (up to a maximum dose of 24 mg-6 mg per day) and also received oral faldaprevir (240 mg) once daily (QD) for 8 days following a 480-mg loading dose. Serial blood samples were taken for pharmacokinetic analysis. The pharmacodynamics of the opioid maintenance regimens were evaluated by the objective and subjective opioid withdrawal scales. Coadministration of faldaprevir with methadone or buprenorphine-naloxone resulted in geometric mean ratios for the steady-state area under the concentration-time curve from 0 to 24 h (AUC(0-24,ss)), the steady-state maximum concentration of the drug in plasma (C(max,ss)), and the steady-state concentration of the drug in plasma at 24 h (C(24,ss)) of 0.92 to 1.18 for (R)-methadone, (S)-methadone, buprenorphine, norbuprenorphine, and naloxone, with 90% confidence intervals including, or very close to including, 1.00 (no effect), suggesting a limited overall effect of faldaprevir. Although individual data showed moderate variability in the exposures between subjects and treatments, there was no evidence of symptoms of opiate overdose or withdrawal either during the coadministration of faldaprevir with methadone or buprenorphine-naloxone or after faldaprevir dosing was stopped. Similar faldaprevir exposures were observed in the methadone- and buprenorphine-naloxone-treated subjects. In conclusion, faldaprevir at 240 mg QD can be coadministered with methadone or buprenorphine-naloxone without dose adjustment, although given the relatively narrow therapeutic windows of these agents, monitoring for opiate overdose and withdrawal may still be appropriate. (This study has been registered at ClinicalTrials.gov under registration no. NCT01637922.).

    Topics: Administration, Oral; Adult; Aminoisobutyric Acids; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Interactions; Female; Humans; Leucine; Male; Methadone; Middle Aged; Oligopeptides; Proline; Quinolines; Substance Withdrawal Syndrome; Substance-Related Disorders; Thiazoles; Young Adult

2015
Novel Buccal Film Formulation of Buprenorphine-Naloxone for the Maintenance Treatment of Opioid Dependence: A 12-Week Conversion Study.
    Clinical therapeutics, 2015, May-01, Volume: 37, Issue:5

    The purpose of this study was to provide a preliminary assessment of the safety, tolerability, symptom control, and acceptability of buprenorphine-naloxone buccal film (BBN) for the maintenance treatment of opioid dependence in patients converted from buprenorphine-naloxone sublingual tablet or film (SLBN), as well as to determine the conversion ratio for switching patients from SLBN to BBN.. This open-label study included adult opioid-dependent subjects stabilized on 8/2 to 32/8 mg/d of SLBN for a minimum of 30 days. Study subjects were converted to a bioequivalent dose of BBN and maintained for 12 weeks.. A total of 249 subjects (mean age 38.7 years, 65.9% male) were converted from SLBN to a single daily dose of BBN, and 79.1% completed the 12-week study. Adverse events and withdrawal symptoms led to discontinuation in 2.4% and 2.0% of BBN-treated subjects, respectively. Rates of constipation reported at baseline declined from 41% just before the initial BBN dose and within 24 hours of the last SLBN dose to 13% after 12 weeks of BBN treatment; treatment-emergent constipation was reported by 2.8% of BBN-treated subjects. Oral mucosal abnormalities were identified in 5% and 0.6% of systematic oral examinations in SLBN- and BBN-treated subjects, respectively. A total of 34 subjects had Clinical Opiate Withdrawal Scale total scores ranging from 10 to 25 (overall mean, 13.8) within 24 hours of taking their last SLBN dose, and scores for these subjects were reduced to a range of 0 to 3 (overall mean, 0.7) at 3 hours after the initial dose of BBN. Treatment compliance was high (108%); <1% of urine samples were buprenorphine-free, and 92.4% of BBN-treated subjects did not have a urine sample that tested positive for a non-prescribed opioid. A total of 91.3% subjects rated the taste of BBN as pleasant or neutral, and 82.5% rated BBN ease of use as easy or neutral. The overall mean final dose of BBN was 8.0/1.4 mg/d, yielding a 2:1 buprenorphine conversion ratio.. Although these results should be considered preliminary due to the open-label design, BBN was overall safe and well tolerated, and seemed to provide adequate symptom control, in the treatment of opioid-dependent subjects previously controlled on SLBN for a minimum of 30 days. There was good adherence to study medication and favorable patient acceptance of the buccal formulation. The SLBN/BBN buprenorphine conversion ratio was 2:1. ClinicalTrials.gov identifier: NCT01666119.

    Topics: Administration, Buccal; Administration, Sublingual; Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Chemistry, Pharmaceutical; Drug Substitution; Female; Humans; Male; Medication Adherence; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Substance Withdrawal Syndrome; Treatment Outcome; Young Adult

2015
Psychometric properties of the adjective rating scale for withdrawal across treatment groups, gender, and over time.
    Journal of substance abuse treatment, 2014, Volume: 46, Issue:2

    The adjective rating scale for withdrawal (ARSW) is commonly used to assess opiate withdrawal in clinical practice and research. The aims of this study were to examine the factor structure of the ARSW, test measurement invariance across gender and treatment groups, and assess longitudinal measurement invariance across the clinical trial. Secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network 000-3, a randomized clinical trial comparing two tapering strategies, was performed. The ARSW was analyzed at baseline, end of taper and 1-month follow-up (N=515 opioid-dependent individuals). A 1-factor model of the ARSW fit the data and demonstrated acceptable reliability. Measurement invariance was supported across gender and taper groups. Longitudinal measurement invariance was not found across the course of the trial, with baseline assessment contributing to the lack of invariance. If change over time is of interest, change from post-treatment through follow-up may offer the most valid comparison.

    Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Follow-Up Studies; Humans; Longitudinal Studies; Male; Middle Aged; Naloxone; Opioid-Related Disorders; Psychiatric Status Rating Scales; Psychometrics; Reproducibility of Results; Sex Factors; Substance Withdrawal Syndrome; Time Factors

2014
Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058.
    The International journal on drug policy, 2012, Volume: 23, Issue:2

    Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors.. We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N=150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models.. BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation.. In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.

    Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; China; Female; Follow-Up Studies; HIV Infections; HIV Seronegativity; Humans; Male; Models, Statistical; Naloxone; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Abuse, Intravenous; Substance Withdrawal Syndrome; Thailand; Time Factors

2012
Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films.
    Clinical pharmacology and therapeutics, 2011, Volume: 89, Issue:3

    A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.

    Topics: Administration, Sublingual; Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Double-Blind Method; Drug Approval; Drug Packaging; Female; Humans; Male; Medication Systems; Middle Aged; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Solubility; Substance Withdrawal Syndrome; Tablets; Taste; United States; United States Food and Drug Administration

2011
Buprenorphine tapering schedule and illicit opioid use.
    Addiction (Abingdon, England), 2009, Volume: 104, Issue:2

    To compare the effects of a short or long taper schedule after buprenorphine stabilization on participant outcomes as measured by opioid-free urine tests at the end of each taper period.. This multi-site study sponsored by Clinical Trials Network (CTN, a branch of the US National Institute on Drug Abuse) was conducted from 2003 to 2005 to compare two taper conditions (7 days and 28 days). Data were collected at weekly clinic visits to the end of the taper periods, and at 1-month and 3-month post-taper follow-up visits.. Eleven out-patient treatment programs in 10 US cities.. Non-blinded dosing with Suboxone during the 1-month stabilization phase included 3 weeks of flexible dosing as determined appropriate by the study physicians. A fixed dose was required for the final week before beginning the taper phase.. The percentage of participants in each taper group providing urine samples free of illicit opioids at the end of the taper and at follow-up.. At the end of the taper, 44% of the 7-day taper group (n = 255) provided opioid-free urine specimens compared to 30% of the 28-day taper group (n = 261; P = 0.0007). There were no differences at the 1-month and 3-month follow-ups (7-day = 18% and 12%; 28-day = 18% and 13%, 1 month and 3 months, respectively).. For individuals terminating buprenorphine pharmacotherapy for opioid dependence, there appears to be no advantage in prolonging the duration of taper.

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Substance Abuse Detection; Substance Withdrawal Syndrome; Time Factors; United States; Young Adult

2009

Other Studies

26 other study(ies) available for buprenorphine--naloxone-drug-combination and Substance-Withdrawal-Syndrome

ArticleYear
A case of buprenorphine-precipitated withdrawal managed with high-dose buprenorphine.
    Family practice, 2022, 03-24, Volume: 39, Issue:2

    Buprenorphine-naloxone has a very high affinity for the mu-receptor and can cause precipitated opioid withdrawal, typically more severe than withdrawal that occurs naturally, when administered while a full mu-opioid receptor agonist remains in a person's system. To avoid precipitated withdrawal, one needs to be in mild to moderate opioid withdrawal at the time of buprenorphine-naloxone induction. Recently, there have been reported cases of precipitated withdrawal occurring in patients taking fentanyl knowingly or unknowingly, despite them being in adequate opioid withdrawal at the time of induction. When this occurs, the current recommendation is to provide 2 mg of buprenorphine-naloxone every 1-2 hours.. Describe a case of successful management of buprenorphine-precipitated withdrawal with escalation of the dose of buprenorphine and highlight implications for future management.. We present a case of a patient with a history of opioid use disorder who was in moderate opioid withdrawal at the time of buprenorphine-naloxone induction and experienced precipitated withdrawal after buprenorphine-naloxone administration.. High-dose buprenorphine-naloxone was given to the patient and precipitated withdrawal subsided after receiving a total of 20 mg. On the next day, the patient had no symptoms of opioid withdrawal and is currently maintained on 16 mg/day.. With the rising prevalence of fentanyl-laced drugs, increased instances of precipitated withdrawal are likely to be encountered. In cases of precipitated withdrawal, giving a high dose of buprenorphine-naloxone rapidly is safe and will allow rapid reversal of withdrawal symptoms.

    Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Fentanyl; Humans; Naloxone; Substance Withdrawal Syndrome

2022
Method for Successfully Inducting Individuals Who Use Illicit Fentanyl Onto Buprenorphine/Naloxone.
    The American journal on addictions, 2021, Volume: 30, Issue:1

    Individuals exposed to fentanyl are at risk of precipitated withdrawal using typical buprenorphine/naloxone induction procedures.. This case series describes buprenorphine/naloxone inductions of four individuals who tested positive for fentanyl.. Buprenorphine-precipitated withdrawal was observed in two individuals who completed a conventional buprenorphine/naloxone induction strategy. Two more individuals completed a revised buprenorphine/naloxone induction strategy that did not precipitate withdrawal.. Using multiple 2 mg doses of buprenorphine/naloxone in patients already in mild/moderate withdrawal improved outcomes.. Persons who use illicit fentanyl might be less likely to experience precipitated withdrawal from this revised buprenorphine/naloxone induction strategy. (Am J Addict 2021;30:83-87).

    Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Female; Fentanyl; Humans; Male; Middle Aged; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome; Young Adult

2021
Buprenorphine Microdose Induction for the Management of Prescription Opioid Dependence.
    Journal of the American Board of Family Medicine : JABFM, 2021, Volume: 34, Issue:Suppl

    Prescription opioid dependence remains a major source of morbidity and mortality in the United States. Patients previously on high-dose opioids may poorly tolerate opioid tapers. Current guidelines support the use of buprenorphine therapy in opioid-tapering protocols, even among patients without a diagnosis of opioid use disorder. Buprenorphine microinduction protocols can be used to transition patients to buprenorphine therapy without opioid withdrawal. From November 2019 to April 2020, we transitioned 8 patients on high-dose prescribed opioids for pain to sublingual buprenorphine-naloxone using a microdose protocol without any evidence of precipitated withdrawal. Six of these patients remain on buprenorphine-naloxone and report improved analgesia. Because of its simplicity, the buprenorphine microinduction protocol can be easily adapted for telemedicine and may help to prevent unnecessary clinic visits and opioid-related admissions in the setting of social distancing regulations during the coronavirus 2019 pandemic.

    Topics: Administration, Sublingual; Aged; Buprenorphine, Naloxone Drug Combination; COVID-19; Female; Humans; Male; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; SARS-CoV-2; Substance Withdrawal Syndrome; Telemedicine

2021
High-dose buprenorphine for treatment of high potency opioid use disorder.
    Drug and alcohol review, 2020, Volume: 39, Issue:2

    A 29-year-old woman presented to detox for treatment of an opioid use disorder with illicit fentanyl. While in detox, she was started on opioid agonist treatment with buprenorphine/naloxone. Unfortunately, she continued to have withdrawal symptoms despite being optimised to a dose of 32 mg. She was given additional PRNs of buprenorphine/naloxone to a total daily dose of 40 mg, which helped to alleviate her symptoms of withdrawal and cravings. She was stabilised on buprenorphine/naloxone 40 mg daily without any side effects and was discharged to a rehabilitation centre.

    Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Dose-Response Relationship, Drug; Female; Fentanyl; Humans; Narcotic Antagonists; Opioid-Related Disorders; Substance Withdrawal Syndrome; Treatment Outcome

2020
Effectiveness of micro-induction approaches to buprenorphine initiation: A systematic review protocol.
    Addictive behaviors, 2020, Volume: 111

    Buprenorphine is first-line opioid agonist therapy for opioid use disorder. Standard regimens require that patients be in opioid withdrawal prior to induction, which is a barrier for many. Micro-induction is a novel induction approach that does not require patients to be in withdrawal. Our primary objective is to synthesize available evidence on the effectiveness of micro-inductions on patient and clinical outcomes compared to standard dosing or other approaches, or evaluated without a comparator group. Secondary objectives are to synthesize evidence on clinical factors that influence micro-induction effectiveness, and to summarize micro-induction regimens described in the literature.. We will search MEDLINE, Embase, CINAHL, Psycinfo, Science Citation Index, and the grey literature for studies that include adolescents or adults with opioid use disorder who received a buprenorphine micro-induction regimen. We will consider any patient or clinical outcomes defined by study authors. We will include controlled and non-controlled interventional studies, observational studies, case reports/series and reports from relevant organizations or guidelines pertinent to our third objective. We will select studies, extract data and assess study quality (using the Downs and Black, and Cochrane Risk of Bias tools) in duplicate. We will narratively synthesize our results, and will meta-analyze outcome measures if multiple studies report common outcomes with acceptably low heterogeneity.. Our review will include the most up-to-date available data on buprenorphine micro-inductions. We anticipate limitations relating to study heterogeneity and quality. We will disseminate study results widely to inform updated guidelines for opioid agonist therapy prescribers.

    Topics: Adolescent; Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Humans; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome

2020
Differences in patient-reported and observer-rated opioid withdrawal symptom etiology, time course, and relationship to clinical outcome.
    Drug and alcohol dependence, 2020, 10-01, Volume: 215

    Although opioid withdrawal ratings are frequently used as primary outcomes for therapeutic trials, there has been limited empirical examination of opioid withdrawal symptom onset or etiology as an outcome, and also little examination of differences in outcomes between patient-reported and observer-ratings of withdrawal. Patient-reported (Subjective Opiate Withdrawal Scale, SOWS) and observer ratings (Clinical Opiate Withdrawal Scale, COWS) of opioid withdrawal collected as part of a randomized controlled residential clonidine, tramadol-extended release, and buprenorphine/naloxone 7-day taper for opioid withdrawal management were analyzed. Withdrawal ratings were collected seven times daily and primary outcomes were percent of participants (N = 103) endorsing symptoms, time of symptom onset, and relationship of scales to taper completion. Participants had variable endorsement of specific symptoms, ranging from 37 % ("feel like vomiting") to 97 % ("change in resting pulse"). Symptoms were more likely to be reported on the SOWS than COWS. Most symptoms began around 8 h after last dose, though comparison of like symptoms across the scales revealed patients reported symptoms on the SOWS > 10 h before they were observed on the COWS. SOWS peak severity score was more closely associated with taper completion than the COWS. Data suggest the patient-reported SOWS demonstrated a higher level of symptom endorsement, earlier detection of symptom onset, and better association with taper completion relative to the observer rated COWS. These data provide insight into the etiology of opioid withdrawal symptom expression and time course that can be used to inform treatment intervention timing and provide a baseline for other withdrawal evaluations.

    Topics: Adult; Analgesics, Opioid; Animals; Buprenorphine, Naloxone Drug Combination; Clonidine; Female; Humans; Male; Middle Aged; Narcotic Antagonists; Narcotics; Opioid-Related Disorders; Patient Reported Outcome Measures; Substance Withdrawal Syndrome; Swine; Tramadol

2020
    Canadian family physician Medecin de famille canadien, 2020, Volume: 66, Issue:12

    To raise awareness of alternative techniques that can facilitate buprenorphine-naloxone treatment for opioid use disorder.. PubMed was searched for articles using the terms. Buprenorphine-naloxone is the first-line option for opioid agonist therapy owing to its superior safety profile compared with methadone. The uptake of this potentially life-saving drug has been limited by unfamiliarity and prescribing restrictions, but perhaps the biggest barrier is the prerequisite that patients be in moderate to severe withdrawal before initiation. An induction option that does not require withdrawal or immediate cessation of current opioid use, termed. Microdosing is a safe and easy-to-implement regimen that can be used in a variety of practice settings with the help of community pharmacists. This article provides an overview of microdosing and serves as a guide to starting and maintaining treatment.

    Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Dose-Response Relationship, Drug; Humans; Naloxone; Opioid-Related Disorders; Substance Withdrawal Syndrome

2020
Are the Patients Ready for the Change?: An Empirical Study to Evaluate the Impact of Change in Formulation of Buprenorphine-Naloxone on Prescription Pattern, Treatment Adherence, and Patient Satisfaction.
    Substance use & misuse, 2019, Volume: 54, Issue:2

    Therapeutic adherence is one of the most important determinants of the outcome with OST. There are no published studies that have explored the impact of change in tablet formulation of buprenorphine-naloxone from one brand to another among patients receiving OST.. The current study is aimed at evaluation of the impact of change in buprenorphine-naloxone formulation on prescription pattern, treatment adherence, and patient satisfaction with OST.. Our study was a cross sectional study based on a cohort of patients who were receiving OST at the study setting. Changes in prescription pattern, reports of subjective opioid withdrawal symptoms, or observation of objective opioid withdrawal symptoms were noted from the case records. The satisfaction and concerns of the patients with buprenorphine-naloxone formulations were assessed using a semi-structured proforma.. An increase in dose of buprenorphine-naloxone was noted in 22 participants, since formulation change. Twenty participants reported that the color of the formulation was different from the previous one, the intensity of effect was reported to be different by 87% participants. Seventy-three percent participants endorsed that increase in dose can be a possible solution to address the perceived differences in the effects of two formulations. Changes in physical attributes of the formulation, perception among treatment seeking peers regarding such changes in treatment, and lack of sense of autonomy regarding one's treatment play a more important role in determining response of the patients to changes in formulation of buprenorphine-naloxone.

    Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Cross-Sectional Studies; Drug Compounding; Humans; Male; Medication Adherence; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Patient Satisfaction; Substance Withdrawal Syndrome

2019
Rapid micro-induction of buprenorphine/naloxone for opioid use disorder in an inpatient setting: A case series.
    The American journal on addictions, 2019, Volume: 28, Issue:4

    Buprenorphine/naloxone has been shown to be effective in the treatment of opioid use disorder. Due to its pharmacological properties, induction can be challenging, time-consuming, and result in sudden onset of withdrawal symptoms.. Retrospective case series (n = 2).. Two patients with opioid use disorder were successfully started on buprenorphine/naloxone using a rapid micro-induction technique that did not cause precipitated withdrawal or require preceding cessation of other opioids.. These cases provide an alternative method for starting buprenorphine/naloxone that offers unique benefits compared to protocols previously described in the literature.. This method can be used to minimize barriers to opioid agonist therapy. (Am J Addict 2019;28:262-265).

    Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Drug Administration Schedule; Female; Hospitalization; Humans; Induction Chemotherapy; Male; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome

2019
Non-prescribed use of methadone and buprenorphine prior to opioid substitution treatment: lifetime prevalence, motives, and drug sources among people with opioid dependence in five Swedish cities.
    Harm reduction journal, 2019, 05-02, Volume: 16, Issue:1

    Opioid substitution treatment (OST) with methadone or buprenorphine is the most effective means of treating opioid dependence. If these substances are used by people who are not undergoing OST, they can however carry serious risks. This article examines the lifetime prevalence, motives, and drug sources for such use, as well as geographical differences in these variables.. Structured interviews were conducted with 411 patients from 11 OST clinics in five Swedish cities. The researchers carried out 280 interviews on-site, while 131 interviews were conducted by specially trained patients through privileged access interviewing. Data were analyzed by frequency and average calculations, cross-tabulations, and χ. The lifetime prevalence of non-prescribed use was 87.8% for methadone, 80.5% for buprenorphine, and 50.6% for buprenorphine/naloxone. Pseudo-therapeutic motives-avoiding withdrawal symptoms, staying clean from heroin, detoxification, or taking care of one's own OST-were commonly cited as driving the use, while using the drugs for euphoric purposes was a less common motive. Most respondents had bought or received the substances from patients in OST, but dealers were also a significant source of non-prescribed methadone and buprenorphine. Geographical differences of use, motives, and sources suggest that prescription practices in OST have a great impact on which substances are used outside of the treatment.. Experiences of non-prescribed use of methadone and buprenorphine are extremely common among those in OST in southern Sweden. As the use is typically driven by pseudo-therapeutic motives, increased access to OST might decrease the illicit demand for these substances. Buprenorphine/naloxone has a lower abuse potential than buprenorphine and should therefore be prioritized as the prescribed drug. Supervised dosage and other control measures are important provisions in the prevention of drug diversion and non-prescribed use among people not undergoing OST.

    Topics: Adult; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cities; Drug Trafficking; Female; Humans; Male; Methadone; Motivation; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Diversion; Prevalence; Self Medication; Substance Withdrawal Syndrome; Sweden

2019
Evidence of validity and reliability of the Opiate Dosage Adequacy Scale (ODAS) in a sample of heroin addicted patients in buprenorphine/naloxone maintenance treatment.
    Drug and alcohol dependence, 2018, 02-01, Volume: 183

    The Opiate Dosage Adequacy Scale (ODAS) is a clinical tool to individually measure the "adequacy" of opioid doses in patients on maintenance treatment. The aim of this paper is to provide evidence for the validity and reliability of the ODAS in a sample of patients in buprenorphine/naloxone (B/N) maintenance treatment.. Cross-sectional study of a convenience sample of B/N-treated patients (n = 316) from four Autonomous Communities in Spain. Participants completed a battery of instruments to assess the following: buprenorphine dose adequacy; heroin dependence severity; psychological adjustment; and patient-desired adjustment of buprenorphine dose.. Exploratory Factor Analysis identified four factors from the ODAS that together account for 85.4% of the total variance: "Heroin craving and use"; "Overmedication"; "Objective opiate withdrawal symptoms (OWS)" and 'Subjective OWS'. Compared to patients with an "inadequate" B/N dose (ODAS), patients with "adequate" doses had less heroin use in the last week (0.01 vs. 0.40; t = -2.73; p < 0.01, 95% CI: -0.67, -0.10), less severe heroin dependence (2.20 vs. 5.26, t = -5.14, p < 0.001; 95% CI: -4.23, -1.88), less psychological distress (3.00 vs. 6.31, t = -4.37, p < 0.001; 95% CI: -4.80, -1.81), and greater satisfaction with their doses (42.1% vs. 13.6%, χ. These findings support the validity and reliability of the ODAS as a tool to measure and assess buprenorphine dose adequacy in the context of an opioid dependency treatment program.

    Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Cross-Sectional Studies; Dose-Response Relationship, Drug; Female; Heroin; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Reproducibility of Results; Substance Withdrawal Syndrome; Treatment Outcome; Young Adult

2018
Methadone to buprenorphine/naloxone induction without withdrawal utilizing transdermal fentanyl bridge in an inpatient setting-Azar method.
    The American journal on addictions, 2018, Volume: 27, Issue:8

    Although buprenorphine/naloxone is widely recognized as first-line therapy for opioid use disorder, the requirement for moderate withdrawal prior to initiation in efforts to avoid precipitated withdrawal can be a barrier to its initiation.. We present a case utilizing transdermal fentanyl as a bridging treatment to eliminate withdrawal during the transition from methadone to buprenorphine/naloxone in a patient who had ongoing significant intravenous heroin use while on methadone.. Patient was successfully transitioned from methadone to buprenorphine/naloxone without a period of withdrawal utilizing transdermal fentanyl as a bridge in an inpatient setting.. Our experience indicates a transdermal depot of fentanyl allows for slow release and elimination while buprenorphine doses are introduced during an induction without presence of withdrawal, as quantified by serial clinical opiate withdrawal score.. This case report highlights ways to minimize barriers to induction of first-line opioid substitution therapy, buprenorphine/naloxone, by eliminating withdrawal during induction phase utilizing a fentanyl bridge within the limitations of a transdermal fentanyl bridge in an inpatient setting. (Am J Addict 2018;XX:1-4).

    Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Delayed-Action Preparations; Fentanyl; Humans; Inpatients; Male; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Withdrawal Syndrome; Treatment Outcome

2018
Buprenorphine-naloxone.
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2018, 11-26, Volume: 190, Issue:47

    Topics: Buprenorphine, Naloxone Drug Combination; Emergency Service, Hospital; Health Services Accessibility; Humans; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Primary Health Care; Prisons; Substance Withdrawal Syndrome

2018
Prevalence and motivations for kratom use in a sample of substance users enrolled in a residential treatment program.
    Drug and alcohol dependence, 2017, 11-01, Volume: 180

    Kratom use in the West has increased recently, yet the prevalence and motives for use among individuals with a history of substance use disorder (SUD) have not been fully examined. Kratom has been documented as a means of treating chronic pain, mitigating drug dependence, and easing withdrawal symptoms, yet it is unclear if substance users are utilizing kratom as a self-medication. Abuse liability, side effects, and overall appeal of kratom remain uncertain.. In April 2017, an anonymous survey regarding kratom use and motivations was completed by clients enrolled in a 12-Step-oriented residential program. 500 respondents with a self-reported history of SUD completed the survey.. 20.8% of respondents endorsed lifetime kratom use and 10.2% reported past-12-month use. Kratom-users were younger (=32.1 vs. 35.9, p<0.001) and were more versatile substance users. A majority (68.9%) of kratom-users reported having used the drug as a means of reducing or abstaining from non-prescription opioids (NPO) and/or heroin, and 64.1% reported using kratom as a substitute for NPO/heroin. 18.4% of kratom-users reported using the drug due to a disability or chronic pain. One-third of kratom-users stated that kratom was a helpful substance and that they would try it again. However, kratom was not preferred and was indicated as having less appeal than NPO, heroin, amphetamines, and Suboxone.. Among substance users, kratom use may be initiated for a variety of reasons, including as a novel form of harm-reduction or drug substitution, particularly in the context of dependence and withdrawal from other substances.

    Topics: Amphetamines; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Heroin; Humans; Motivation; Prevalence; Residential Treatment; Self Medication; Self Report; Substance Withdrawal Syndrome; Substance-Related Disorders; Surveys and Questionnaires

2017
Why is buprenorphine coformulated with naloxone?
    JAAPA : official journal of the American Academy of Physician Assistants, 2017, Volume: 30, Issue:11

    Combination buprenorphine-naloxone is a cornerstone of outpatient treatment for substance use disorder, and is more widely accessible in primary care. Because oral buprenorphine has been diverted and abused for its euphoric properties, a combination formulation was developed and will trigger withdrawal symptoms if injected IV.

    Topics: Buprenorphine, Naloxone Drug Combination; Drug Combinations; Humans; Narcotic Antagonists; Opioid-Related Disorders; Substance Withdrawal Syndrome

2017
Buprenorphine-naloxone treatment responses differ between young adults with heroin and prescription opioid use disorders.
    The American journal on addictions, 2017, Volume: 26, Issue:8

    Opioid use disorder among young adults is rising sharply with an increase in morbidity and mortality. This study examined differences in treatment response to a fixed dose of buprenorphine-naloxone between heroin (HU) and prescriptions opioids (POU) users.. Eighty opioid dependent young adults (M = 22 years) were treated with buprenorphine-naloxone 16-4 mg/day for 8 weeks. Differences between HU (N = 17) and POU (N = 63) on changes in weekly opioid use, opioid craving, withdrawal, and depression symptoms were analyzed with mixed-effects regression models.. The HU had an overall mean proportion of weekly opioid use of .32 (SD = .14) compared to POU's weekly mean of .24 (SD = .15) showing a significant main effect (Z = 2.21, p = .02). Depressive symptoms (CES-D scores) were elevated at baseline for both groups (HU: M = 23.1, SD = 11.9; PO: M = 22.2, SD = 9.4), but only POU improved significantly to a score of 9.88 (SD = 7.4) compared to HU's score of 18.58 (SD = 10.3) at week 8 (Z = 2.24, p = .02). There were no significant differences in treatment retention, craving, or withdrawal symptoms.. Treatment response to 16-4 mg/day of buprenorphine-naloxone was significantly diminished for heroin users relative to opioid prescription users in weekly opioid use. Heroin users also had persistent depressive symptoms suggesting the need for close monitoring.. These data suggest that young heroin users might require higher doses of buprenorphine. (Am J Addict 2017;26:838-844).

    Topics: Adolescent; Age Factors; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Cognitive Behavioral Therapy; Combined Modality Therapy; Craving; Drug Therapy, Combination; Female; Heroin Dependence; Humans; Male; Memantine; Opiate Substitution Treatment; Opioid-Related Disorders; Psychotherapy, Group; Substance Withdrawal Syndrome; Substance-Related Disorders; Young Adult

2017
Intravenous Abuse of Tropicamide in Opioid Use Disorder: Presentation of 2 Cases.
    Substance abuse, 2015, Volume: 36, Issue:2

    Tropicamide is an antimuscarinic ophthalmic solution used to produce short-acting mydriasis and cycloplegia. Topical abuse of ophthalmic solutions has been reported, but intravenous (IV) abuse of tropicamide seems to be a new phenomenon.. The authors present 2 patients with concomitant IV tropicamide abuse and opioid use disorder. Patients were hospitalized and started on buprenorphine/naloxone treatment for opioid withdrawal. Patients' reports about tropicamide effects are remarkable, as they claimed that tropicamide increased the efficacy of heroin while decreasing and delaying the withdrawal symptoms.. Although anticholinergics have been known to be abused for their euphoric effects, these cases' motivation to use tropicamide seemed to extend beyond its euphoric effect and was also based on its interaction with heroin. It is feared that tropicamide abuse may become more frequent. Health professionals should be aware of this trend so that symptoms of misuse and intoxication can be recognized, and ophthalmologists should consider the abuse potential of anticholinergic eye drops when prescribing them.

    Topics: Adult; Buprenorphine, Naloxone Drug Combination; Humans; Male; Muscarinic Antagonists; Opioid-Related Disorders; Substance Abuse, Intravenous; Substance Withdrawal Syndrome; Tropicamide

2015
Examining the factor structure of the Clinical Opiate Withdrawal Scale: A secondary data analysis from the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003.
    Drug and alcohol dependence, 2015, Jul-01, Volume: 152

    The Clinical Opiate Withdrawal Scale (COWS) is used to assess withdrawal in clinical trials and practice. The aims of this study were to examine the inter-item correlations and factor structure of the COWS in opioid-dependent men and women.. This is a secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network 0003, a randomized clinical trial that compared buprenorphine/naloxone tapering strategies. The trial included 11 sites in 10 US cities. Participants were opioid-dependent individuals (n=516) that had data on the COWS. The COWS at study baseline was analyzed in this study.. Inter-item correlations showed weak to moderate relationships among the items. A 1-factor model did not fit the data for men (comparative fit index (CFI)=.801, root mean square error of approximation (RMSEA)=.073, weighted root mean square residual (WRMR)=1.132) or women (CFI=.694, RMSEA=.071, WRMR=.933), where resting pulse rate was not related to withdrawal for men, and yawning and gooseflesh skin was not related to withdrawal for women. A reduced model comprised of only the 8 items that were significantly related to the construct of withdrawal in both men and women, and an exploratory 2-factor model, were also assessed but not retained due to inconsistencies across gender.. When traditional psychometric models are applied to the COWS, it appears that the scale may not relate to a single underlying construct of withdrawal. Further research testing the hypothesized factor structure in other opioid-dependent samples is needed.

    Topics: Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Female; Humans; Male; Middle Aged; Opioid-Related Disorders; Psychometrics; Randomized Controlled Trials as Topic; Substance Withdrawal Syndrome; United States

2015
"Sub is a weird drug:" A web-based study of lay attitudes about use of buprenorphine to self-treat opioid withdrawal symptoms.
    The American journal on addictions, 2015, Volume: 24, Issue:5

    Illicit use of buprenorphine has increased in the U.S., but our understanding of its use remains limited. This study aims to explore Web-forum discussions about the use of buprenorphine to self-treat opioid withdrawal symptoms.. PREDOSE, a novel Semantic Web platform, was used to extract relevant posts from a Web-forum that allows free discussions on illicit drugs. First, we extract information about the total number of buprenorphine-related posts per year between 2005 and 2013. Second, PREDOSE was used to identify all posts that potentially contained discussions about buprenorphine and opioid withdrawal. A total number of 1,217 posts that contained these terms were extracted and entered into NVivo data base. A random sample of 404 (33%) posts was selected and content analyzed.. Buprenorphine-related posts increased over time, peaking in 2011. The posts were about equally divided between those that expressed positive and negative views about the effectiveness of buprenorphine in relieving withdrawal symptoms. Web-forum participants emphasized that buprenorphine's effectiveness may become compromised because of the "size of a person habit," and/or when users repeatedly switch back and forth between buprenorphine and other illicit opioids. Most posts reported use of significantly lower amounts of buprenorphine (≤2 mg) than doses used in standard treatment. Concomitant use of other psychoactive substances was also commonly reported, which may present significant health risks.. Our findings highlight the usefulness of Web-based data in drug abuse research and add new information about lay beliefs about buprenorphine that may help inform prevention and policy measures.

    Topics: Adult; Attitude to Health; Buprenorphine, Naloxone Drug Combination; Cross-Sectional Studies; Female; Health Surveys; Humans; Hydrocodone; Internet; Middle Aged; Opioid-Related Disorders; Oxycodone; Self Medication; Substance Withdrawal Syndrome; Treatment Outcome

2015
A case of rhabdomyolysis associated with severe opioid withdrawal.
    The American journal on addictions, 2015, Volume: 24, Issue:5

    While the risk of opioid overdose is widely accepted, the dangers of opioid withdrawal are far less clearly defined. The purpose of this publication is to provide evidence against the erroneous clinical dictum that opioid withdrawal is never life-threatening.. This case report (N = 1) illustrates an unfortunate, common scenario of a man abusing prescription opioids and heroin. His attempt at self-detoxification with buprenorphine-naloxone resulted in life-threatening opioid withdrawal. A detailed account of each day of his withdrawal period was documented by patient and family report and review of all medical records. The patient was contacted three months after hospitalization to verify information and determine progress in treatment and abstinence from drugs and alcohol.. A review of the literature was completed on severe cases of precipitated and spontaneous opioid withdrawal followed by a discussion of the significance as it relates to this case.. Given the widespread use of prescription opioids and opioid maintenance treatment, physicians should be aware of the complications of acute opioid withdrawal and should be equipped to treat these complications.

    Topics: Acute Kidney Injury; Administration, Intranasal; Administration, Oral; Administration, Sublingual; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Follow-Up Studies; Heroin; Heroin Dependence; Humans; Intensive Care Units; Male; Opioid-Related Disorders; Oxycodone; Oxymorphone; Prescription Drugs; Rhabdomyolysis; Self Medication; Substance Withdrawal Syndrome; Young Adult

2015
Suboxone misuse along the opiate maintenance treatment pathway.
    Journal of addictive diseases, 2013, Volume: 32, Issue:1

    This study explores strategies that Suboxone misusers utilize while in drug treatment. Ethnographic interviews were conducted with 14 patients who had cycled in and out of Suboxone treatment. The objective of the study is to identify strategies implemented by patients who intermittently use opiates/opioids while in Suboxone treatment. Findings indicate that some patients serially stop and start treatment in a Harm Reduction setting in New York City. Many patients suggest that they manage their opiate/opioid dependency through a sequential use of Suboxone and heroin to avoid withdrawal and to continue their misuse of opiates/opioids. Results are discussed in conjunction with the difficulties inherent to substance abuse treatment and suggestions for improvement are offered.

    Topics: Adult; Behavior, Addictive; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Combinations; Drug Users; Female; Harm Reduction; Heroin Dependence; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; New York City; Opiate Substitution Treatment; Patient Acceptance of Health Care; Prescription Drug Misuse; Qualitative Research; Recurrence; Social Environment; Substance Abuse Treatment Centers; Substance Withdrawal Syndrome

2013
Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire.
    Clinical drug investigation, 2012, Jul-01, Volume: 32, Issue:7

    The dosing of opioid receptor agonist medications adequately and on an individual basis is crucial in the pharmacotherapy of opioid dependence. Clinical tools that are able to measure dose appropriateness are sorely needed. The recently developed and validated Opiate Dosage Adequacy Scale (ODAS) comprehensively evaluates the main outcomes relevant for methadone dose optimization, namely relapse, cross-tolerance, objective and subjective withdrawal symptoms, craving and overdose. Based on the ODAS, we developed a new assessment tool (BUprenorphine-naloxone Dosage Adequacy eVAluation [BUDAVA]) for evaluating dosage adequacy in patients in treatment with buprenorphine-naloxone.. The main goal of this observational study was to explore whether the BUDAVA questionnaire could be used to assess buprenorphine-based, long-term substitution therapy for heroin addiction.. The study included heroin-dependent patients who had been in treatment with buprenorphine-naloxone for at least 3 months. Patients (n = 196) were recruited from 11 drug abuse treatment centres in Italy. Dosage adequacy was assessed with the BUDAVA questionnaire. Patients classified as inadequately treated had their dosage modified. After 1 week, they were again administered the questionnaire to assess the adequacy of the new dosage.. The buprenorphine-naloxone dosage was found to be inadequate in 61 of the 196 patients. In 13 patients, the treatment scored as inadequate only in the subjective withdrawal symptoms item of the questionnaire and therefore no dosage adjustment was made in the 2 weeks that have characterized this work. The remaining 48 inadequately treated patients had their dosage modified (42 dose increases and six dose decreases). After 1 week on the modified dosage, in 24 of these patients the new regimen was found by the assessment with the questionnaire to be adequate.. These preliminary results suggest that the BUDAVA questionnaire may be useful for guiding buprenorphine-naloxone maintenance dose adjustments in heroin-dependent patients.

    Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chi-Square Distribution; Drug Dosage Calculations; Drug Monitoring; Heroin Dependence; Humans; Italy; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Predictive Value of Tests; Receptors, Opioid; Secondary Prevention; Substance Withdrawal Syndrome; Surveys and Questionnaires; Time Factors; Treatment Outcome

2012
Buprenorphine for human immunodeficiency virus/hepatitis C virus-coinfected patients: does it serve as a bridge to hepatitis C virus therapy?
    Journal of addiction medicine, 2012, Volume: 6, Issue:3

    Buprenorphine is associated with enhanced human immunodeficiency virus (HIV) treatment outcomes including increased antiretroviral therapy initiation rates, adherence, and CD4 cell counts among HIV-infected opioid-dependent individuals. Buprenorphine facilitates hepatitis C virus (HCV) treatment in opioid-dependent patients with HCV monoinfection. Less is known about buprenorphine's role in HIV/HCV coinfection.. We conducted a retrospective chart review to evaluate HCV care for HIV-infected buprenorphine patients in the first 4 years of buprenorphine's integration into a Rhode Island HIV clinic.. Sixty-one patients initiated buprenorphine. All had HCV antibody testing; 57 (93%) were antibody-positive. All antibody-positive patients underwent HCV RNA testing; 48 (84%) were RNA-positive. Of these, 15 (31%) were not referred to HCV care. Among chronically infected patients, 3 received HCV treatment after buprenorphine; all had cirrhosis and none achieved viral eradication. At buprenorphine induction, most patients had inadequately controlled HIV infection, with detectable HIV RNA (59%) or CD4 cell count less than or equal to 350/μL (38%).. Buprenorphine has shown limited success to date as a bridge to HCV treatment within an HIV clinic. Buprenorphine's stabilization of opioid dependence and HIV disease may permit the use of HCV therapy over time.

    Topics: Adult; Antiretroviral Therapy, Highly Active; Antiviral Agents; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Comorbidity; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Hepatitis C, Chronic; HIV Infections; Humans; Male; Middle Aged; Naloxone; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Retrospective Studies; Substance Withdrawal Syndrome

2012
Pain and continued opioid use in individuals receiving buprenorphine-naloxone for opioid detoxification: secondary analyses from the Clinical Trials Network.
    Journal of substance abuse treatment, 2010, Volume: 38 Suppl 1

    Pain complaints are common among individuals with opioid dependence. However, few studies investigate pain during opioid detoxification or the impact this pain has on continued opioid use. This secondary analysis utilized data from two Clinical Trials Network randomized controlled trials of buprenorphine-naloxone for short-term opioid detoxification to examine the extent to which pain was associated with continued opioid use during and immediately following a 13-day detoxification protocol. At follow-up, more severe pain was associated with a greater number of self-reported days of opioid use during the prior 30 days (p < .05) but was not associated with urine toxicology results collected at follow-up. These results, although mixed, have potentially important clinical implications for assessing and addressing pain during opioid detoxification. Pain that is experienced during and immediately following medically monitored detoxification may be associated with continued opioid use. These findings lend further support for continued research on pain among patients with opioid dependence.

    Topics: Adult; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Pain; Randomized Controlled Trials as Topic; Severity of Illness Index; Substance Withdrawal Syndrome

2010
Lack of reduction in buprenorphine injection after introduction of co-formulated buprenorphine/naloxone to the Malaysian market.
    The American journal of drug and alcohol abuse, 2009, Volume: 35, Issue:2

    Diversion of buprenorphine (BPN) has been described in settings where it is legally prescribed and has resulted in increasing concern. To address this concern, co-formulation of buprenorphine/naloxone (BPN/NLX) replaced buprenorphine alone in Malaysia in December 2006.. To assess the significance of BPN/NLX introduction, 41 BPN/NLX injectors in Kuala Lumpur, Malaysia were recruited using a modified snowball recruitment technique.. In January 2007, all subjects had previously injected BPN alone. During the transition from injecting BPN alone to co-formulated BPN/NLX, the mean daily BPN injection dose increased from 1.88 mg (range 1.0-4.0 mg) to 2.49 mg/day (p < .001). Overall, 18 (44%) subjects increased their daily amount of injection while 22 (54%) had no change in dose; only one subject reduced the amount of injection. Development of opioid withdrawal symptoms was the primary outcome, however the only symptom that was significantly associated with BPN/NLX dosage was the report of "stomach pains" (p = .01). In logistic regression analysis, the development of opioid withdrawal symptoms was associated with increased benzodiazepine injection and increased syringe sharing.. These data suggests that the introduction of BPN/NLX did not reduce injection related risk behaviors such as syringe sharing and was associated with increased benzodiazepine use. Evidence-based approaches to treat BPN injection are urgently needed.

    Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Combinations; Humans; Logistic Models; Malaysia; Male; Middle Aged; Naloxone; Narcotic Antagonists; Needle Sharing; Opioid-Related Disorders; Risk-Taking; Substance Abuse, Intravenous; Substance Withdrawal Syndrome; Young Adult

2009
Addiction: a nurse's story. Opioids became an obsession--until he was caught.
    The American journal of nursing, 2007, Volume: 107, Issue:8

    Topics: Adaptation, Psychological; Analgesics, Opioid; Attitude of Health Personnel; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug and Narcotic Control; Humans; Male; Naloxone; Nursing Staff, Hospital; Occupational Health; Opioid-Related Disorders; Professional Impairment; Self-Help Groups; Shame; Substance Abuse Treatment Centers; Substance Withdrawal Syndrome; Theft

2007