Monthly buprenorphine depot injections maintain abstinence in patients with opioid use disorders

Reference

Haight BR, Learned SM, Laffont CM, et al, for the RB-US-13-0001 Study Investigators. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2019;393(10173):778-790.

Synopsis

These researchers identified adults younger than 65 years who had a moderate to severe opioid use disorder (4 of 11 DSM-V criteria) for at least 3 months and were seeking treatment. After an active run-in period in which everyone received sublingual buprenorphine-naloxone, the researchers randomized those with no allergic reactions, mild withdrawal symptoms, and mild cravings to receive either placebo (n = 100); buprenorphine 300 mg injected monthly for 2 months, followed by 100-mg monthly injections (n = 203); or buprenorphine 300 mg injected monthly for 2 months, followed by 300-mg monthly injections (n = 201). I often rail against active run-in periods, but in this case, I believe the goal was to safely achieve opioid abstinence. All patients also received individual drug counseling. Over the 24 weeks of follow-up, all participants provided urine for drug testing and completed a variety of scales to self-assess opioid and other substance use, withdrawal symptoms, and cravings. By the end of the study, there was a massive drop-out rate—66 of those taking placebo, 125 of those taking the low-dose maintenance, and 129 taking the high-dose maintenance dropped out. At the end of 24 weeks, only 5% of the weekly urine samples from placebo-treated patients had confirmed opioid abstinence compared with 43% and 41% in the low-dose and high-dose buprenorphine-treated patients, respectively. Their secondary outcome, the proportion of patients achieving over 80% abstinence, occurred in only 2% of placebo-treated patients compared with 28% and 29% of low-dose and high-dose patients, respectively (number needed to treat = 4; 95% CI 3 - 5). Headache was the most commonly reported side effect (6% in the placebo group, 9% and 8% in the low and high treatment groups, respectively), followed by constipation, nausea, and injection-site pruritus.