Oral methadone versus sublingual buprenorphine for the treatment of acute opioid withdrawal: A triple-blind, double-dummy, randomized control trial.

Abstract

Opioid use disorder (OUD) is a global problem with treatment involving an initial assisted withdrawal followed by maintenance phase. Methadone and buprenorphine are most commonly used agents for acute opioid withdrawal management (AOWM), but their comparative effectiveness remains uncertain. This study was aimed at comparing the efficacy and safety of oral methadone and sublingual buprenorphine for AOWM in in-patient setting. A randomized double-dummy clinical trial was conducted with 79 patients (ages 18-60) admitted with OUD a tertiary-care center, New Delhi, India over three years (2017-2019). Participants received either oral methadone (20mg/day; n = 40) or sublingual buprenorphine (3.6mg/day; n = 39) in a fixed schedule allowing gradual tapering from day 4-10. The primary outcome was treatment completion rate, with secondary outcomes including withdrawal severity (COWS, SOWS scores), opioid craving (VAS), additional medication use, and side effects. The study was conducted after approval from the Institutional Ethics Committee (IEC). Both groups were comparable in terms of sociodemographic and baseline clinical parameters. Both groups had similar treatment completion rates (buprenorphine: 82 %, methadone: 82.5 %; p = 0.95). While both medications significantly reduced withdrawal symptoms and cravings over time, methadone showed greater reductions in withdrawal severity (COWS, SOWS scores; p = 0.01). Side effects were comparable between groups. Methadone and buprenorphine demonstrated similar efficacy in treatment completion rates for acute opioid withdrawal. These findings suggest that methadone, alongside buprenorphine, can be an effective and safe option for acute opioid withdrawal management in inpatient settings. CTRI/2017/03/0079977.