Aim: To test if opium tincture (OT) was non-inferior to methadone in retaining participants in opioid agonist treatment (OAT).
Design: A Phase III, multi-centre, parallel-group, non-inferiority, double-blind randomized controlled trial with an allocation ratio of 1:1. Participants were provided treatment and followed for a period of 85 days.
Objectives: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder.
Methods: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions.