buprenorphine--naloxone-drug-combination and Heroin-Dependence

The multi-site Prescription Opioid Addiction Treatment Study (POATS), conducted by the National Drug Abuse Treatment Clinical Trials Network, was the largest clinical trial yet conducted with patients dependent upon prescription opioids (N=653). In addition to main trial results, the study yielded numerous secondary analyses, and included a 3.5-year follow-up study, the first of its kind with this population. This paper reviews key findings from POATS and its follow-up study.. The paper summarizes the POATS design, main outcomes, predictors of outcome, subgroup analyses, the predictive power of early treatment response, and the long-term follow-up study.. POATS examined combinations of buprenorphine-naloxone of varying duration and counseling of varying intensity. The primary outcome analysis showed no overall benefit to adding drug counseling to buprenorphine-naloxone and weekly medical management. Only 7% of patients achieved a successful outcome (abstinence or near-abstinence from opioids) during a 4-week taper and 8-week follow-up; by comparison, 49% of patients achieved success while subsequently stabilized on buprenorphine-naloxone. Long-term follow-up results were more encouraging, with higher abstinence rates than in the main trial. Patients receiving opioid agonist treatment at the time of follow-up were more likely to have better outcomes, though a sizeable number of patients succeeded without agonist treatment. Some patients initiated risky use patterns, including heroin use and drug injection. A limitation of the long-term follow-up study was the low follow-up rate.. POATS was the first large-scale study of the treatment of prescription opioid dependence; its findings can influence both treatment guidelines and future studies.

Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Combined Modality Therapy; Counseling; Follow-Up Studies; Heroin Dependence; Humans; Male; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Misuse

Access to opioid agonist treatment can be associated with extensive waiting periods with significant health and financial burdens. This study aimed to determine whether patients with heroin dependence dispensed buprenorphine-naloxone weekly have greater reductions in heroin use and related adverse health effects 12-weeks after commencing treatment, compared to waitlist controls and to examine the cost-effectiveness of this strategy.. An open-label waitlist RCT was conducted in an opioid treatment clinic in Newcastle, Australia. Fifty patients with DSM-IV-TR heroin dependence (and no other substance dependence) were recruited. The intervention group (n=25) received take-home self-administered sublingual buprenorphine-naloxone weekly (mean dose, 22.7±5.7mg) and weekly clinical review. Waitlist controls (n=25) received no clinical intervention. The primary outcome was heroin use (self-report, urine toxicology verified) at weeks four, eight and 12. The primary cost-effectiveness outcome was incremental cost per additional heroin-free-day.. Outcome data were available for 80% of all randomized participants. Across the 12-weeks, treatment group heroin use was on average 19.02days less/month (95% CI -22.98, -15.06, p<0.0001). A total 12-week reduction in adjusted costs including crime of $A5,722 (95% CI 3299, 8154) in favor of treatment was observed. Excluding crime, incremental cost per heroin-free-day gained from treatment was $A18.24 (95% CI 4.50, 28.49).. When compared to remaining on a waitlist, take-home self-administered buprenorphine-naloxone treatment is associated with significant reductions in heroin use for people with DSM-IV-TR heroin dependence. This cost-effective approach may be an efficient strategy to enhance treatment capacity.

Topics: Adult; Analgesics, Opioid; Australia; Buprenorphine, Naloxone Drug Combination; Cost-Benefit Analysis; Female; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Treatment Outcome; Waiting Lists

In spite of the clinical utility of buprenorphine, parenteral abuse of this medication has been reported in several laboratory investigations and in the real world. Studies have demonstrated lower abuse liability of the buprenorphine/naloxone combination relative to buprenorphine alone. However, clinical research has not yet examined the utility of the combined formulation to deter intranasal use in a buprenorphine-maintained population. Heroin-using volunteers (n = 12) lived in the hospital for 8-9 weeks and were maintained on each of three sublingual buprenorphine doses (2, 8, 24 mg). Under each maintenance dose, participants completed laboratory sessions during which the reinforcing and subjective effects of intranasal doses of buprenorphine (8, 16 mg), buprenorphine/naloxone (8/2, 8/8, 8/16, 16/4 mg) and controls (placebo, heroin 100 mg, naloxone 4 mg) were assessed. Intranasal buprenorphine alone typically produced increases in positive subjective effects and the 8 mg dose was self-administered above the level of placebo. The addition of naloxone dose dependently reduced positive subjective effects and increased aversive effects. No buprenorphine/naloxone combination dose was self-administered significantly more than placebo. These data suggest that within a buprenorphine-dependent population, intranasal buprenorphine/naloxone has reduced abuse potential in comparison to buprenorphine alone. These data strongly argue in favor of buprenorphine/naloxone rather than buprenorphine alone as the more reasonable option for managing the risk of buprenorphine misuse.

Topics: Administration, Intranasal; Administration, Sublingual; Adult; Analysis of Variance; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Dose-Response Relationship, Drug; Double-Blind Method; Female; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Psychomotor Performance; Reinforcement, Psychology; Self Administration; Surveys and Questionnaires; Treatment Outcome; Young Adult

Most research examining buprenorphine has been conducted with heroin users. Few studies have examined buprenorphine pharmacotherapy for prescription opioid users. Data were from a randomized controlled trial of behavioral treatment provided for 16weeks on a platform of buprenorphine pharmacotherapy and medication management. We compared heroin (H, n=54), prescription opioid (PO, n=54) and combination heroin+prescription opioid (POH, n=71) users to test the hypothesis that PO users will have better treatment outcomes compared with heroin users. The PO group provided more opioid-negative urine drug screens over the combined treatment period (PO:70%, POH:40%, H:38%, p<0.001) and at the end of the combined treatment period (PO:65%, POH:31%, H:33%, p<0.001). Retention was lowest in the H group (PO:80%, POH:65%, H:57%, p=0.039). There was no significant difference in buprenorphine dose between the groups. PO users appear to have better outcomes in buprenorphine pharmacotherapy compared to those reporting any heroin use, confirming that buprenorphine pharmacotherapy is effective in PO users.

Topics: Adult; Analgesics, Opioid; Behavior Therapy; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Heroin Dependence; Humans; Male; Middle Aged; Naloxone; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Misuse; Treatment Outcome

The objective of this secondary analysis was to explore differences in baseline clinical characteristics and opioid replacement therapy treatment outcomes by type (heroin, opioid analgesic [OA], or combined [heroin and OA]) and route (injector or non-injector) of opioid use.. A total of 1,269 participants (32.2% female) were randomized to receive one of two study medications (methadone or buprenorphine/naloxone [BUP]). Of these, 731 participants completed the 24-week active medication phase. Treatment outcomes were opioid use during the final 30 days of treatment (among treatment completers) and treatment attrition.. Non-opioid substance dependence diagnoses and injecting differentiated heroin and combined users from OA users. Non-opioid substance dependence diagnoses and greater heroin use differentiated injectors from non-injectors. Further, injectors were more likely to be using at end of treatment compared with non-injectors. OA users were more likely to complete treatment compared with heroin users and combined users. Non-injectors were more likely than injectors to complete treatment. There were no interactions between type of opioid used or injection status and treatment assignment (methadone or BUP) on either opioid use or treatment attrition.. Findings indicate that substance use severity differentiates heroin users from OA users and injectors from non-injectors. Irrespective of medication, heroin use and injecting are associated with treatment attrition and opioid misuse during treatment. These results have particular clinical interest, as there is no evidence of superiority of BUP over methadone for treating OA users versus heroin users.

Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Heroin Dependence; Humans; Male; Methadone; Middle Aged; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Severity of Illness Index; Substance Abuse, Intravenous; Treatment Outcome; Young Adult

The focus of drug policy in the UK has shifted markedly in the past 5 years to move beyond merely emphasising drug abstinence towards maximising individuals' opportunities for recovery. The UK government continues to recognise the prescribing of narcotic medications indicated for opiate dependence as a key element of these individuals' recovery journey. This article describes a small, naturalistic comparison of the efficacy of the two most commonly prescribed opiate substitute medications in the UK--methadone hydrochloride (methadone oral solution) and Suboxone (buprenorphine-naloxone sublingual tablets)--for reducing current heroin users' (n = 34) days of heroin use, and preventing short-term abstainers (n = 37) from relapsing to regular heroin use. All patients had been prescribed either methadone or Suboxone for maintenance for 6 months prior to intake. Results showed that when controlling for a number of patient-level covariates, both methadone and Suboxone significantly reduced current users' days of heroin use between the 90 days prior to intake and at the 8-month follow-up, with Suboxone yielding a significantly larger magnitude reduction in heroin use days than methadone. Methadone and Suboxone were highly and equally effective for preventing relapse to regular heroin use, with all but 3 of 37 (91.9%) patients who were abstinent at intake reporting past 90-day point prevalence heroin abstinence at the 8-month follow-up. Overall, prescribing methadone or Suboxone for eight continuous months was highly effective for initiating abstinence from heroin use, and for converting short-term abstinence to long-term abstinence. However, the study design, which was based on a relatively small sample size and was not able randomise patients to medication and so could not control for the effects of potential prognostic factors inherent within each patient group, means that these conclusions can only be made tentatively. These positive but preliminary indications of the comparative efficacy of methadone and Suboxone for treating opiate dependence now require replication in a well-powered, randomised controlled trial.

Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Follow-Up Studies; Health Policy; Heroin Dependence; Humans; Male; Methadone; Naloxone; Opiate Substitution Treatment; Opioid-Related Disorders; Recurrence; Time Factors; Treatment Outcome; United Kingdom

Clinical parameters for determining buprenorphine dose have not been adequately examined in treatment outcome research.. This study is a secondary analysis of data collected in a recently completed comparison of buprenorphine taper schedules conducted as part of the National Institute on Drug Abuse's Clinical Trials Network to assess whether participant baseline characteristics are associated with buprenorphine dose.. After 3 weeks of flexible dosing, 516 participants were categorized by dose provided in the final dosing week (9.3% received a final week dose of 8 mg buprenorphine, 27.3% received 16 mg, and 63.4% received 24 mg).. Findings show that final week dose groups differed in baseline demographic and drug use characteristics including education, heroin use, route of drug administration, withdrawal symptoms, and craving. These groups also differed in opioid use during the four dosing weeks, with the lowest use in the 8 mg group and highest use in the 24 mg group (p < .0001). Additional analyses address withdrawal symptoms and craving.. Final week dose groups differed in demographic and drug use characteristics, and the group receiving the largest final week dose had the highest rate of continued opioid use. These findings may contribute to the development of clinical guidelines regarding buprenorphine dose in the treatment of opioid dependence; however, further investigations that include random assignment to dose by baseline characteristics are needed.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Heroin Dependence; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; National Institute on Drug Abuse (U.S.); Opiate Substitution Treatment; Opioid-Related Disorders; United States

To compare the effectiveness and cost-effectiveness of unobserved versus observed dosing of patients seeking treatment of heroin dependence.. Randomized controlled trial and cost-effectiveness analysis. Setting Specialist out-patient drug treatment centres in Australia.. Heroin users seeking maintenance treatment.. Participants were allocated randomly to observed or unobserved dosing for 3 months. All subjects received buprenorphine-naloxone and weekly clinical reviews.. Primary end-points were retention in treatment and heroin use at 3 months. Costs of treatment were measured (in Australian dollars, AU$) and cost-effectiveness compared. Secondary outcomes included quality of life, psychological symptoms and use of non-opioid drugs.. A total of 119 subjects were randomized and analysed. At 3 months, 33/58 (57%) randomized to unobserved treatment, and 37/61 (61%) observed were retained (log-rank chi2 = 0.04, df = 1, P = 0.84). On an intention-to-treat analysis, reductions in days of heroin use in the preceding month, from baseline to 3 months, did not differ significantly; 18.5 days (95% CI: 21.8-15.3) and 22.0 days (95% CI: 24.3-19.7), respectively (Mann-Whitney U = 807.5, P = 0.13). The mean cost for the unobserved group was AU$1,663 (95% CI 1308-2017) per treatment episode, significantly less than the mean cost for the observed group at AU$2,138 (95% CI 1713-2562).. Retention and heroin use was not significantly different between observed and unobserved dosing groups. Attendance for observed dosing was not associated with worse retention. Treatment with close clinical monitoring, but no observation of dosing, was significantly cheaper and therefore significantly more cost-effective.

Topics: Adult; Australia; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cost-Benefit Analysis; Directly Observed Therapy; Drug Combinations; Health Care Costs; Heroin Dependence; Humans; Male; Naloxone; Narcotic Antagonists; Patient Compliance; Self Administration; Statistics as Topic

Reverse takotsubo cardiomyopathy is triggered by emotional or physical stress and has a presentation similar to that of acute coronary syndrome. A 39-year-old woman with a history of heroin use disorder presented with intractable nausea, vomiting, and diarrhea. She was diagnosed with heroin withdrawal and started on buprenorphine-naloxone. On day 2 of her hospitalization, she developed chest heaviness and had an elevated troponin I level of 3.2 ng/mL (reference range, 0.015-0.045 ng/mL); electrocardiography showed new T-wave inversions in the anterior and inferior leads. Emergent coronary angiography showed patent coronary arteries, and left ventriculography showed basal hypokinesis and apical hyperkinesis, consistent with reverse takotsubo cardiomyopathy secondary to heroin withdrawal. She was started on antihypertensive agents, and her buprenorphine-naloxone dose was increased. At her 3-month follow-up visit, she reported no symptoms consistent with angina or heart failure. This appears to be the first report of heroin withdrawal causing reverse takotsubo cardiomyopathy. Awareness of this association can lead to earlier recognition and treatment of reverse takotsubo cardiomyopathy.

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Electrocardiography; Female; Heroin; Heroin Dependence; Humans; Takotsubo Cardiomyopathy

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

In the wake of North America's opioid crisis, access to evidence-based treatment for opioid use disorder (OUD) is of critical importance. While buprenorphine/naloxone and methadone are currently indicated as first-line medications for the treatment of OUD, there are a proportion of individuals who do not benefit from these therapies. Recent Canadian guidelines suggest the use of alternate therapies, including slow-release oral morphine or injectable opioid agonist therapy (iOAT) for individuals unsuccessful with either methadone or buprenorphine/naloxone. While the guidelines highlight the need to intensify OUD treatment as disease severity increases, equally important is the consideration for deintensification of treatment (eg, from iOAT to an oral opioid agonist treatment (OAT) option) following successful stabilisation. Literature addressing how best to accomplish this, however, is currently lacking. Accordingly, the case presented here describes a patient that successfully transitions from iOAT to oral buprenorphine/naloxone using a novel induction approach termed microdosing.

Topics: Administration, Oral; Buprenorphine, Naloxone Drug Combination; Drug Administration Schedule; Drug Substitution; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment

Patient satisfaction with methadone or buprenorphine-naloxone can be multidimensionally and specifically assessed by using, respectively, the Scale to Assess Satisfaction with Medications for Addiction Treatment-Methadone for Heroin addiction (SASMAT-METHER) or the SASMAT-Buprenorphine-Naloxone for Heroin addiction (SASMAT-BUNHER). The factor structures of the SASMAT-METHER and SASMAT-BUNHER show substantial commonalities. The objective of the present study is to evaluate the replicability of the SASMAT-METHER factor structure using data from the SASMAT-BUNHER development study in order to obtain an instrument that can be used to compare patient satisfaction with methadone vs. buprenorphine-naloxone.. Secondary analysis of SASMAT-BUNHER data provided by 205 participants in the original validation study of that scale (Pérez de los Cobos et al., 2018). Using the SASMAT-METHER component solution (17 items, 3 factors) as the target structure, a principal component analysis was performed on the data set comprised of the corresponding 17 SASMAT-BUNHER items using an oblique semi-specified Procrustean rotation. Additionally, Tucker congruence coefficients were computed to examine the correspondence between the two solutions.. The factor structures of SASMAT-METHER and the 17-item version of the SASMAT-BUNHER can be considered equal given that the overall Tucker's congruence coefficient of factorial similarity was 0.972, with individual component congruencies ranging from 0.960 to 0.995.. The SASMAT-METHER component solution can serve as a single common tool to compare methadone vs. buprenorphine-naloxone in terms of patient satisfaction. This finding supports the feasibility of using a common metric to specifically assess satisfaction with medications to treat heroin dependence.

Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Female; Heroin; Heroin Dependence; Humans; Male; Methadone; Patient Satisfaction; Spain

Switching from methadone to buprenorphine/naloxone remains a challenge for heroin users receiving methadone maintenance treatment (MMT). The present study aimed to investigate the predictors for failed switching from methadone to buprenorphine/naloxone among patients receiving MMT.. This 5-year retrospective study included 168 individuals (138 males and 30 females) with opioid dependence who attempted to switch from methadone to buprenorphine/naloxone at our MMT clinics in Taiwan. We excluded patients with psychiatric comorbidity and other substance use disorders except nicotine. A univariate Cox proportional hazards regression model (Cox model) was used to estimate the potential factors of subsequent failed switching, followed by a multivariate Cox model to identify significant predictors after adjusting for other covariates.. Seventy of the 168 participants (41.7%) failed switching from methadone to buprenorphine/naloxone. After forward selection in the Cox hazard regression model, a greater average dose of methadone (HR = 1.02; P = 0.01), greater maximal maintenance dose of MMT (HR = 1.02; P < 0.001), greater average dose of buprenorphine (HR = 1.10; P = 0.021), and lower average attendance rate during the three months before switching (HR = 0.09; P = 0.002) were significantly associated with failed switching.. This study with limited participants showed that dose of methadone, dose of buprenorphine, and attendance rates were significantly associated with failed switching. Clinicians should discuss with their patients about tapering the dose of methadone and improving their attendance if they want to switch from methadone to buprenorphine. Further studies are necessary to verify whether our findings generalize to other populations.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Comorbidity; Female; Heroin Dependence; Humans; Male; Methadone; Opiate Substitution Treatment; Retrospective Studies; Taiwan

The switch from methadone to buprenorphine-naloxone for individuals with heroin dependence is associated with several obstacles and challenges. Such patients may experience discomfort from discontinuing methadone, precipitated withdrawal symptoms induced by buprenorphine-naloxone, and poor psychosocial adjustments such as anticipatory anxiety regarding severe opioid withdrawal. We herein describe a 46-year-old man with a history of heroin dependence who underwent Traditional Chinese Medicine (TCM)-facilitated switching from methadone to buprenorphine-naloxone. No precipitated withdrawal was induced by buprenorphine-naloxone. The drug-switching process was successful and smooth. He maintained abstinence from heroin for the following year. In this case, we applied TCM for enhancement of methadone metabolism and detoxification, analgesic effects, and anxiolytic and hypnotic effects during the drug switch. We observed that TCM effectively facilitated the switch from methadone to buprenorphine-naloxone in our case. Further studies regarding TCM-facilitated treatment for heroin dependence should be conducted.

Topics: Buprenorphine, Naloxone Drug Combination; Heroin Dependence; Humans; Male; Medicine, Chinese Traditional; Methadone; Middle Aged; Treatment Outcome

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

Buprenorphine dosage is a crucial factor influencing outcomes of buprenorphine treatment for heroin use disorders. Therefore, the aim of the present study is to identify naturally occurring profiles of heroin-dependent patients regarding individualized management of buprenorphine dosage in clinical practice of buprenorphine-naloxone maintenance treatment.. 316 patients receiving buprenorphine-naloxone maintenance treatment were surveyed at 16 Spanish centers during the stabilization phase of this treatment. Patients were grouped using cluster analysis based on three key indicators of buprenorphine dosage management: dose, adequacy according to physician, and adjustment according to patient. The clusters obtained were compared regarding different facets of patient clinical condition.. Four clusters were identified and labeled as follows (buprenorphine average dose and percentage of participants in each cluster are given in brackets): "Clinically Adequate and Adjusted to Patient Desired Low Dosage" (2.60 mg/d, 37.05%); "Clinically Adequate and Adjusted to Patient Desired High Dosage" (10.71 mg/d, 29.18%); "Clinically Adequate and Patient Desired Reduction of Low Dosage" (3.38 mg/d, 20.0%); and "Clinically Inadequate and Adjusted to Patient Desired Moderate Dosage" (7.55 mg/d, 13.77%). Compared to patients from the other three clusters, participants in the latter cluster reported more frequent use of heroin and cocaine during last week, lower satisfaction with buprenorphine-naloxone as a medication, higher prevalence of buprenorphine-naloxone adverse effects and poorer psychological adjustment.. Our results show notable differences between clusters of heroin-dependent patients regarding buprenorphine dosage management. We also identified a group of patients receiving clinically inadequate buprenorphine dosage, which was related to poorer clinical condition.

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Cluster Analysis; Female; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Opiate Substitution Treatment; Patient Satisfaction; Precision Medicine; Spain; Substance Abuse Treatment Centers; Surveys and Questionnaires; Treatment Outcome

Until now, no specific tool has been available to measure heroin-dependent patient satisfaction with buprenorphine-naloxone as a medication. The purpose of the present study was to develop the Scale to Assess Satisfaction with Medications for Addiction Treatment-Buprenorphine-Naloxone for Heroin addiction (SASMAT-BUNHER) and to examine its validity and reliability.. The SASMAT-BUNHER was developed from a pool of 44 self-administered items grouped into nine theoretical domains, as follows: Overall Satisfaction, Pharmacotherapy, Initiation, Anti-Addictive Effect on Heroin, Mental State, Physical State, Personal Functioning, Acceptability, and Anti-Addictive Effect on Secondary Substances. The Treatment Satisfaction Questionnaire for Medication 1.4 version (TSQM 1.4) was used for convergent validation. Participants were 316 heroin-dependent patients in maintenance treatment with buprenorphine-naloxone sublingual tablets at 16 different treatment centres.. Principal component analysis of the SASMAT-BUNHER revealed a 5-factor structure that accounted for 65.1% of total variance. Based on similarities between empirically-obtained factors and theoretical domains, Factors 1 through 5 were named 'Mental and Physical State' (10 items), 'Anti-Addictive Effect on Other Substances' (5 items), 'Anti-Addictive Effect on Heroin' (4 items), 'Personal Functioning' (3 items), and 'Acceptability' (4 items). All factors showed acceptable internal consistency (Cronbach's alpha coefficients: 0.744-0.925) and test-retest reliability (intraclass correlation coefficients: 0.704-0.895). Correlation between SASMAT-BUNHER and TSQM 1.4 total scores was moderate (Pearson r = 0.552). Moreover, SASMAT-BUNHER total scores of patients reporting absence of buprenorphine-naloxone side effects were higher than those of their counterparts.. These results support the validity and reliability of the SASMAT-BUNHER.

Topics: Adult; Aged; Behavior Rating Scale; Buprenorphine, Naloxone Drug Combination; Female; Heroin Dependence; Humans; Male; Middle Aged; Opiate Substitution Treatment; Patient Satisfaction; Psychometrics; Self Report; Surveys and Questionnaires; Young Adult

Illicit fentanyl use has become wide spread in the US, causing high rates of overdose deaths among people who use drugs. This study describes patterns and perceptions of fentanyl exposure among opioid users in Rhode Island.. A mixed methods study was conducted via questionnaire with a convenience sample of 149 individuals using illicit opioids or misusing prescription opioids in Rhode Island between January and November 2016. Of these, 121 knew of fentanyl and reported known or suspected exposure to fentanyl in the past year. Semi-structured interviews were conducted with the first 47 participants.. Study participants were predominantly male (64%) and white (61%). Demographic variables were similar across sample strata. Heroin was the most frequently reported drug of choice (72%). Self-reported exposure to illicit fentanyl in the past year was common (50.4%, n=61). In multivariate models, regular (at least weekly) heroin use was independently associated with known or suspected fentanyl exposure in the past year (adjusted prevalence ratio (APR)=4.07, 95% CI: 1.24-13.3, p=0.020). In interviews, users described fentanyl as unpleasant, potentially deadly, and to be avoided. Participants reporting fentanyl exposure routinely experienced or encountered non-fatal overdose. Heroin users reported limited ability to identify fentanyl in their drugs. Harm reduction strategies used to protect themselves from fentanyl exposure and overdose, included test hits, seeking prescription opioids in lieu of heroin, and seeking treatment with combination buprenorphine/naloxone. Participants were often unsuccessful in accessing structured treatment programs.. Among illicit opioid users in Rhode Island, known or suspected fentanyl exposure is common, yet demand for fentanyl is low. Fentanyl-contaminated drugs are generating user interest in effective risk mitigation strategies, including treatment. Responses to the fentanyl epidemic should be informed by the perceptions and experiences of local users. The rapid scale-up of buprenorphine/naloxone provision may slow the rate of fentanyl-involved overdose deaths.

Topics: Adolescent; Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Drug Contamination; Drug Overdose; Female; Fentanyl; Harm Reduction; Heroin; Heroin Dependence; Humans; Illicit Drugs; Interviews as Topic; Male; Middle Aged; Prevalence; Rhode Island; Risk; Surveys and Questionnaires; Young Adult

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

To test if polysubstance use profiles and drug-related outcomes differ between those receiving and not receiving opioid substitution therapies (OST) among people who inject drugs (PWID).. An annual cross-sectional, sentinel sample of PWID across Australia.. Data came from 3 years (2011-13) of the Illicit Drug Reporting System (IDRS).. A total of 2673 participants who injected drugs from the combined national IDRS samples of 2011 (n = 868), 2012 (n = 922) and 2013 (n = 883).. Latent class analysis (LCA) was used to summarize participants' self-reported use of 18 types of substances, with the resulting polysubstance use profiles then associated with participant experience of a number of drug-related outcomes.. Polysubstance use profiles exhibiting a broad range of substance use were generally at increased risk of negative drug-related outcomes, whether or not participants were receiving OST, including thrombosis among OST receivers [odds ratio (OR) = 2.13, 95% confidence intervals (CI) = 1.09-4.17], injecting with used needles among OST receivers and non-receivers, respectively (OR = 2.78, 95% CI = 1.50-5.13; OR = 2.15, 95% CI = 1.34-3.45) and violent criminal offences among OST receivers and non-receivers, respectively (OR =2.30, 95% CI = 1.16-4.58; OR = 1.87, 95% CI = 1.14-3.07). An important exception was non-fatal overdose which was related specifically to a class of PWID who were not receiving OST and used morphine frequently (OR = 1.83, 95% CI = 1.06-3.17) CONCLUSION: Regardless of opioid substitution therapies usage, people who inject drugs who use a broad-range of substances experience greater levels of injecting-related injuries and poorer health outcomes and are more likely to engage in criminal activity than other groups of people who inject drugs.

Topics: Abscess; Adolescent; Adult; Alcoholism; Amphetamine-Related Disorders; Analgesics, Opioid; Australia; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cocaine-Related Disorders; Cross-Sectional Studies; Drug Overdose; Female; Heroin Dependence; Humans; Male; Marijuana Abuse; Methadone; Middle Aged; Needle Sharing; Odds Ratio; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Abuse, Intravenous; Substance-Related Disorders; Thrombosis; Violence; Young Adult

The aims of the present study were to evaluate 1-year retention in program and buprenorphine/naloxone (BUP/NAL) treatment, and abstinence of heroin-dependent adolescents. The present study included the follow-up information of 112 heroin dependent adolescents who took BUP/NAL treatment for the first time in a specific inpatient unit. Retention and abstinence were assessed by self-report and urine drug screen at each visit. Mean age was 16.9 years, with 101 (90.2%) male. Program retention was 81.3% at day 30, and 24.1% at 1 year, while retention in BUP/NAL treatment was 69.6% at day 30 and 16.1% at 1 year. Rates of abstinence were 69.0% at day 30 and 10.3% at 1 year. There was a significant positive correlation between duration of inpatient treatment and program retention, treatment retention, abstinence (p < 0.05 for all), and between the dose and treatment retention, abstinence (p < 0.05 for both). Patients with comorbid psychiatric disease were more likely to be retained in treatment for 3 months, and in program for 6 months (p < 0.05, for all). Patients who completed inpatient treatment were more likely to be retained in treatment for 1 year, and in program for 9 months, and to be abstinent for 1 year (p < 0.05, for all). Findings suggested that starting BUP/NAL treatment in an inpatient unit might result in better outcomes compared to literature. Duration of inpatient treatment, the completion of inpatient treatment, BUP/NAL dose, and having a comorbid psychiatric disease seemed to be important factors for heroin-dependent adolescents in retention and abstinence within 1-year period.

Topics: Adolescent; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Female; Follow-Up Studies; Heroin Dependence; Humans; Male; Medication Adherence; Opiate Substitution Treatment; Outcome Assessment, Health Care

The aim of this study was to develop and validate a method for the determination of buprenorphine (BUP), norbuprenorphine (NBUP) and naloxone (NAL) in fingernails and urine samples collected from former heroin users under suboxone substitution therapy. The analytes were extracted by solid-liquid or solid-phase extraction and were analyzed by liquid chromatography-mass spectrometry. The validation of the analytical methods developed included linearity, recovery, accuracy, precision, ion suppression, sensitivity of interfaces and limits of determination and quantification. The validated methods were applied to samples from 46 individuals. The majority of the urine samples were positive for all analytes (93.5% for BUP, 95.7% for NBUP and 84.8% for NAL). In nails, a higher detection rate was observed for NBUP and BUP (89.1%), compared with NAL (10.9%). The median values of the NBUP/BUP and the NAL/BUP ratio were 2.5 and 0.3 in urine and 0.8 and 0.3 in nails, respectively. A statistically significant correlation was found between the BUP, NBUP and total BUP (BUP and NBUP) concentrations in urine and those in nails. A weak correlation was observed between the daily dose (mg/day) and total BUP (P = 0.069), or NBUP (P = 0.072) concentrations in urine. In contrast, a strong correlation was found between the total amount of BUP administered during the last 12 months and total BUP (P = 0.038), or NBUP (P = 0.023) concentrations in urine. Moreover urine BUP, NBUP and total BUP concentrations correlated significantly. Our study demonstrated successfully the application of the developed method for the determination of the three analytes in urine and nails.

Topics: Adult; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chromatography, Liquid; Female; Heroin Dependence; Humans; Male; Mass Spectrometry; Nails; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Reproducibility of Results; Sensitivity and Specificity; Solid Phase Extraction

This is a case report describing a reversal of fentanyl overdose with naloxone nasal spray. The patient was not aware that he overdosed on fentanyl being sold as heroin.. The Veterans Health Administration (VHA) has implemented an initiative to provide education for veterans, their families, friends and significant others about opioid overdose and use of naloxone reversal kits. The Atlanta VA Medical Center adopted this program to reduce the risk of opioid overdose in high risk patients.. Over the past year, we provided educational sessions for 63 veterans and their families. We also prescribed 41 naloxone kits. We have received three reports of opioid overdose reversal with use of naloxone kits prescribed by the Atlanta VA Medical Center.. The authors recommend that public health administrators and policy makers advocate for the implementation of these programs to reduce the rising number of overdose death in the United States and worldwide.

Topics: Buprenorphine, Naloxone Drug Combination; Drug Overdose; Fentanyl; First Aid; Heroin; Heroin Dependence; Humans; Illicit Drugs; Male; Naloxone; Nasal Sprays; Recurrence; Veterans

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

Topics: Buprenorphine, Naloxone Drug Combination; Heroin Dependence; Humans; Hypoxia; Male; Methadone; Middle Aged; Polysomnography; Respiration; Sleep; Sleep Apnea, Central

Injection drug users (IDUs) are at increased risk of various medical conditions, including bacterial skin and soft tissue infections (SSTIs). SSTIs, which are painful and can lead to life-threatening complications, are common but scarcely studied.. To investigate life time, past 12 month and past 30-day prevalence for SSTI related to injection drug use, in IDUs at Malmö syringe exchange program (Malmö SEP). To investigate factors associated with having ever had an SSTI.. IDUs were recruited from Malmö SEP (N = 80). They participated in a survey with questions about demographics, drug use, and experience of SSTIs. Factors independently associated with self-reported SSTI ever were assessed using logistic regression analysis.. The lifetime reported prevalence of SSTI was 58%, past 12 months 30%, and past 30 days 14%. Factors independently associated with SSTI ever were age (adjusted odds ratio [AOR] = 1.09; 95% confidence interval [CI] = 1.01-1.18), female sex (AOR = 6.75; 95% CI = 1.40-32.47), having ever injected prescribed drugs (AOR = 52.15; 95% CI = 5.17-525.67), and having ever injected in the neck (AOR = 8.08; 95% CI = 1.16-56.08).. SSTI is common among IDUs in Malmö. Women and those injecting in the neck or injecting prescribed drugs (crushed tablets/liquids), are more likely to have had an SSTI.

Topics: Adult; Amphetamine-Related Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Users; Female; Heroin Dependence; Housing; Humans; Ill-Housed Persons; Logistic Models; Male; Methadone; Methylphenidate; Middle Aged; Neck; Needle-Exchange Programs; Odds Ratio; Opioid-Related Disorders; Prescription Drugs; Prevalence; Sex Factors; Skin Diseases, Bacterial; Soft Tissue Infections; Substance Abuse, Intravenous; Surveys and Questionnaires; Sweden; Young Adult

In the current study, buprenorphine (BUP) and its major metabolite, nor-buprenorphine (NBUP), were determined in hair samples from former heroin users following Suboxone® treatment. Hair samples from 36 subjects were analyzed. The drugs of interest were isolated from hair by solid-liquid extraction with methanol and were determined by liquid chromatography-mass spectrometry, using an electrospray ionization interface. The analytical parameters of the method (such as linearity, limits of quantification, recovery, accuracy, and precision) were determined. The inter-quartile range of BUP levels was from 11.4 to 37.4 pg/mg (mean value 56.6 pg/mg) for the proximal hair segment, from 5.8 to 43.3 pg/mg for the middle hair segment (mean value 25.3 pg/mg), while a range from 4.3 to 33.9 pg/mg (mean value 105.2 pg/mg) for the distant to the root hair segment was determined. For NBUP the corresponding inter-quartile range was from 27.0 to 147.6 for the proximal segment (mean value 95.4 pg/mg), from 21.5 to 164.7 pg/mg for the middle segment (mean value 102.0 pg/mg) and from 20.4 to 103.6 pg/mg for the distant segment (mean value 156.8 pg/mg). The mean BUP/NBUP concentration ratio was 0.5. The daily dose of Suboxone® correlated significantly with BUP and NBUP levels in hair (p = 0.001 and p = 0.023) as well as with the BUP/NBUP ratio (p = 0.010). No significant correlation was found between the levels of BUP and NBUP and the duration of Suboxone® administration. The developed and validated method was successfully used for the determination of BUP and NBUP in hair samples collected from former heroin users under Suboxone® treatment.

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chromatography, Liquid; Female; Hair; Heroin Dependence; Humans; Male; Mass Spectrometry; Naloxone; Narcotic Antagonists

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

conduct needs assessments and treatment compliance evaluations in MMT and Suboxone Substitution State Programs in Georgia (Republic of). 506 patients (2 females) were surveyed (92% on Methadone, 8% on Suboxone) from 6 Tbilisi and 4 regional State Programs in 2011 November. Mean age - 40±8,56 (22-65) year; 254 (51.4%) were in treatment for 1-3 year. Evaluation was carried out on the base of structured self-questionnaire that covers demographics, drug use history, general drug use trends, psychotherapeutic sessions' acceptance and open label question regarding treatment challenges and satisfaction. 305 (60.3%) attended individual and 57 (11.3%) group psychotherapy sessions with 50.79% attending once/month or rare. The main reason given for therapy non-attendance - no needs for it (29.48%); the main drugs before admission - heroin (80.04%), buprenorphine (53.49%); Main drugs used in Georgia nowadays - desomorphine ("crocodile"), alcohol and marihuana. Commonly used drugs by program patients (136 positive answers) - alcohol-13.62%, marihuana-10.39%, pregabalin - 8.17%, opioids- 6.62% (mostly-"crocodile"), home-made stimulants-6.23%, sedatives -5.45%. 55.4% are extremely satisfied with treatment, 82.4% - with program staff. Patients' main wishes- free of charge programs (46.4%) and provide take-home doses (22.07%). Methadone and Suboxone ST are being well accepted in Georgia and appear to be reducing illegal opioid use. However, the psychotherapeutic sessions' attendance is very low.

Topics: Adult; Aged; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Georgia (Republic); Government Programs; Heroin Dependence; Humans; Hypnotics and Sedatives; Male; Marijuana Abuse; Methadone; Middle Aged; Naloxone; Needs Assessment; Opiate Substitution Treatment; Patient Compliance; Patient Satisfaction; Psychotherapy; Substance-Related Disorders; Surveys and Questionnaires; Young Adult

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