Dataset Information

Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial.

ABSTRACT: To compare long-term outcomes among participants randomized to buprenorphine or methadone.Follow-up was conducted in 2011-14 of 1080 opioid-dependent participants entering seven opioid treatment programs in the United States between 2006 and 2009 and randomized (within each program) to receive open-label buprenorphine/naloxone or methadone for up to 24 weeks; 795 participants completed in-person interviews (~74% follow-up interview rate) covering on average 4.5 years.Outcomes were indicated by mortality and opioid use. Covariates included demographics, site, cocaine use and treatment experiences.Mortality was not different between the two randomized conditions, with 23 (3.6%) of 630 participants randomized to buprenorphine having died versus 26 (5.8%) of 450 participants randomized to methadone. Opioid use at follow-up was higher among participants randomized to buprenorphine relative to methadone [42.8 versus 31.7% positive opioid urine specimens, P < 0.01, effect size (h) = 0.23 (0.09, 0.38); 5.8 days versus 4.4 days of past 30-day heroin use, P < 0.05, effect size (d) = 0.14 (0.00, 0.28)]. Opioid use during the follow-up period by randomization condition was also significant (F(7,39,600) = 3.16; P < 0.001) due mainly to less treatment participation among participants randomized to buprenorphine than methadone. Less opioid use was associated with both buprenorphine and methadone treatment (relative to no treatment); no difference was found between the two treatments. Individuals who are white or used cocaine at baseline responded better to methadone than to buprenorphine.There are few differences in long-term outcomes between buprenorphine and methadone treatment for opioid dependence, and treatment with each medication is associated with a strong reduction in opioid use.

SUBMITTER: Hser YI

PROVIDER: S-EPMC4801718 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial.

Hser Yih-Ing YI Evans Elizabeth E Huang David D Weiss Robert R Saxon Andrew A Carroll Kathleen M KM Woody George G Liu David D Wakim Paul P Matthews Abigail G AG Hatch-Maillette Mary M Jelstrom Eve E Wiest Katharina K McLaughlin Paul P Ling Walter W

Addiction (Abingdon, England) 20160113 4

<h4>Aims</h4>To compare long-term outcomes among participants randomized to buprenorphine or methadone.<h4>Design, setting and participants</h4>Follow-up was conducted in 2011-14 of 1080 opioid-dependent participants entering seven opioid treatment programs in the United States between 2006 and 2009 and randomized (within each program) to receive open-label buprenorphine/naloxone or methadone for up to 24 weeks; 795 participants completed in-person interviews (~74% follow-up interview rate) cove ...[more]

PMID: 26599131

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Project description:AimsTo examine patient and medication characteristics associated with retention and continued illicit opioid use in methadone (MET) versus buprenorphine/naloxone (BUP) treatment for opioid dependence.Design, settings and participantsThis secondary analysis included 1267 opioid-dependent individuals participating in nine opioid treatment programs between 2006 and 2009 and randomized to receive open-label BUP or MET for 24 weeks.MeasurementsThe analyses included measures of patient characteristics at baseline (demographics; use of alcohol, cigarettes and illicit drugs; self-rated mental and physical health), medication dose and urine drug screens during treatment, and treatment completion and days in treatment during the 24-week trial.FindingsThe treatment completion rate was 74% for MET versus 46% for BUP (P < 0.01); the rate among MET participants increased to 80% when the maximum MET dose reached or exceeded 60 mg/day. With BUP, the completion rate increased linearly with higher doses, reaching 60% with doses of 30-32 mg/day. Of those remaining in treatment, positive opioid urine results were significantly lower [odds ratio (OR) = 0.63, 95% confidence interval (CI) = 0.52-0.76, P < 0.01] among BUP relative to MET participants during the first 9 weeks of treatment. Higher medication dose was related to lower opiate use, more so among BUP patients. A Cox proportional hazards model revealed factors associated with dropout: (i) BUP [versus MET, hazard ratio (HR) = 1.61, CI = 1.20-2.15], (ii) lower medication dose (<16 mg for BUP, <60 mg for MET; HR = 3.09, CI = 2.19-4.37), (iii) the interaction of dose and treatment condition (those with higher BUP dose were 1.04 times more likely to drop out than those with lower MET dose, and (iv) being younger, Hispanic and using heroin or other substances during treatment.ConclusionsProvision of methadone appears to be associated with better retention in treatment for opioid dependence than buprenorphine, as does use of provision of higher doses of both medications. Provision of buprenorphine is associated with lower continued use of illicit opioids.

Project description:AIMS:To compare long-term criminal justice outcomes among opioid-dependent individuals randomized to receive buprenorphine or methadone. DESIGN, SETTING AND PARTICIPANTS:A 5-year follow-up was conducted in 2011-14 of 303 opioid-dependent participants entering three opioid treatment programs in California, USA in 2006-09 and randomized to receive either buprenorphine/naloxone or methadone. INTERVENTION AND COMPARATOR:Participants received buprenorphine/naloxone (BUP; n = 179) or methadone (MET; n = 124) for 24 weeks and then were tapered off their treatment over ≤ 8 weeks or referred for ongoing clinical treatment. Midway through the study, the randomization scheme was switched from 1 : 1 BUP : MET to 2 : 1 because of higher dropout in the BUP arm. MEASUREMENTS:Study outcomes included arrests and self-reported incarceration. Predictors included randomization condition (buprenorphine versus methadone), age, gender, race/ethnicity, use of cocaine, drug injection in the 30 days prior to baseline and study site. Treatment status (buprenorphine, methadone, none) during follow-up was included as a time-varying covariate. FINDINGS:There was no significant difference by randomization condition in the proportion arrested (buprenorphine: 55.3%, methadone: 54.0%) or incarcerated (40.9%, 47.3%) during follow-up. Among methadone-randomized individuals, arrest was less likely with methadone treatment (0.50, 0.35-0.72) during follow-up (relative to no treatment) and switching to buprenorphine had a lower likelihood of arrest than those receiving no treatment (0.39, 0.18-0.87). Among buprenorphine-randomized individuals, arrest was less likely with receipt of buprenorphine (0.49, 0.33-0.75) during follow-up and switching to methadone had a similar likelihood of arrest as methadone-randomized individuals receiving no treatment. Likelihood of arrest was also negatively associated with older age (0.98, 0.96-1.00); it was positively associated with Hispanic ethnicity (1.63, 1.04-2.56), cocaine use (2.00, 1.33-3.03), injection drug use (2.19, 1.26-3.83), and study site. CONCLUSIONS:In a US sample of people treated for opioid use disorder, continued treatment with either buprenorphine or methadone was associated with a reduction in arrests relative to no treatment. Cocaine use, injection drug use, Hispanic ethnicity and younger age were associated with higher likelihood of arrest.

Project description:IntroductionDespite a recent meta-analysis including 31 randomised controlled trials comparing methadone and buprenorphine for the treatment of opioid use disorder, important knowledge gaps remain regarding the long-term effectiveness of different treatment modalities across individuals, including rigorously collected data on retention rates and other treatment outcomes. Evidence from real-world data represents a valuable opportunity to improve personalised treatment and patient-centred guidelines for vulnerable populations and inform strategies to reduce opioid-related mortality. Our objective is to determine the comparative effectiveness of methadone versus buprenorphine/naloxone, both overall and within key populations, in a setting where both medications are simultaneously available in office-based practices and specialised clinics.Methods and analysisWe propose a retrospective cohort study of all adults living in British Columbia receiving opioid agonist treatment (OAT) with methadone or buprenorphine/naloxone between 1 January 2008 and 30 September 2018. The study will draw on seven linked population-level administrative databases. The primary outcomes include retention in OAT and all-cause mortality. We will determine the effectiveness of buprenorphine/naloxone vs methadone using intention-to-treat and per-protocol analyses-the former emulating flexible-dose trials and the latter focusing on the comparison of the two medication regimens offered at the optimal dose. Sensitivity analyses will be used to assess the robustness of results to heterogeneity in the patient population and threats to internal validity.Ethics and disseminationThe protocol, cohort creation and analysis plan have been approved and classified as a quality improvement initiative exempt from ethical review (Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics). Dissemination is planned via conferences and publications, and through direct engagement and collaboration with entities that issue clinical guidelines, such as professional medical societies and public health organisations.

Dataset Information

Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial.

Publications

Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial.

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