Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial

Abstract

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. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175).

Results: To be reported after final analysis.

Conclusions: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.

Keywords: clinical trial; methadone; opioid; opium; substance use.

© 2019 John Wiley & Sons, Ltd.

Figures

Figure 1

Dosing strategy for treatment with opium tincture or methadone in patients with opioid use disorder, where one unit of medication is equal to 1 ml of opium tincture or 0.5 ml of methadone. (a) Day 1, morning; (b) day 1, afternoon; (c) day 2–3; and (d) day 4–84

Figure 2

Flow diagram of patients with opioid use disorder in clinical trial of medication assisted treatment with opium tincture or methadone