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

Int J Methods Psychiatr Res. 2019 Mar;28(1):e1768. doi: 10.1002/mpr.1768. Epub 2019 Feb 4.

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.

Publication types

  • Comparative Study
  • Equivalence Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Clinical Protocols
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Methadone / therapeutic use*
  • Opiate Substitution Treatment / methods*
  • Opioid-Related Disorders / drug therapy*
  • Opium / therapeutic use*

Substances

  • Opium
  • Methadone

Associated data

  • ClinicalTrials.gov/NCT02502175