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Randomized Controlled Trial
. 2016 Apr;111(4):695-705.
doi: 10.1111/add.13238. Epub 2016 Jan 13.

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

Yih-Ing Hser  1 , Elizabeth Evans  1 , David Huang  1 , Robert Weiss  1 , Andrew Saxon  2 , Kathleen M Carroll  3 , George Woody  4 , David Liu  5 , Paul Wakim  5 , Abigail G Matthews  6 , Mary Hatch-Maillette  7 , Eve Jelstrom  6 , Katharina Wiest  8 , Paul McLaughlin  9 , Walter Ling  1
Affiliations
Randomized Controlled Trial

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

Yih-Ing Hser et al. Addiction. 2016 Apr.

Abstract

Aims: To compare long-term outcomes among participants randomized to buprenorphine or methadone.

Design, setting and participants: 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.

Measurements: Outcomes were indicated by mortality and opioid use. Covariates included demographics, site, cocaine use and treatment experiences.

Findings: 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.

Conclusions: 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.

Keywords: Buprenorphine; longitudinal; methadone; mortality; opioid dependence; opioid use; outcomes.

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Conflict of interest statement

Declaration of Interest: Authors disclosing relevant financial interests, activities, relationships, and affiliations are:

  1. Walter Ling: Consultant to Reckitt Benckiser Pharmaceuticals.

  2. Andrew Saxon: Consultant to Reckitt Benckiser Pharmaceuticals, advisory board member for Alkermes, Inc., and receive royalties as an editor for UpToDate.

  3. George Woody: Consultant to Reckitt Benckiser Pharmaceuticals.

  4. All other authors report no financial or other possible conflicts of interest.

Figures

Figure 1
Figure 1
Days of Opioid Use by the Two Randomized Groups (N = 795)
Figure 2
Figure 2
Percent of Participants in Treatment† by the Two Randomized Groups (N = 795) †Treatment is defined as received MET or BUP treatment medication
Figure 3
Figure 3
Estimated Days of Opioid Use by the Two Randomized Groups Based on Model 4 (N = 795)
Figure 4
Figure 4
Estimated Days of Opioid Use by the Types of Treatment Based on Model 4 (N = 795)†† ††The number of participants in each type of treatment varied in each month and is therefore not indicated in the figure; on average over the follow-up period, each month there were about 14.2% of the participants in BUP treatment, 38.5% in MET treatment, and 46.9% in neither BUP nor MET treatment.
See this image and copyright information in PMC

References

    1. Hser YI, Evans E, Grella C, Ling W, Anglin D. Long-term course of opioid addiction. Harv Rev Psychiatry. 2015;23:76–89. - PubMed
    1. NIH Consensus Statement. Effective medical treatment of opiate addiction. National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction. JAMA. 1998;280:1936–1943. - PubMed
    1. Bell J, Trinh L, Butler B, Randall D, Rubin G. Comparing retention in treatment and mortality in people after initial entry to methadone and buprenorphine treatment. Addiction. 2009;104:1193–1200. - PubMed
    1. Connock M, Juarez-Garcia A, Jowett S, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technol Assess. 2007;11:1–171. iii–iv. - PubMed
    1. Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;2:CD002207. - PMC - PubMed

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