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

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