Comparing Opium Tincture (OT) With Methadone for Medication-assisted Treatment of Opioid Use Disorder

Summary

Patients with opioid use disorder seeking medication-assisted treatment will be recruited. Each participant will be allocated to one of the two study groups with the equal chance of receiving either opium tincture (OT) or methadone. Participants, clinical and research staff will not be aware of the medication that each patient receives. This study aims to test whether OT is as equally effective as methadone at retaining participants with opioid use disorder in medication-assisted treatment.

Timeline

Start

2017-06-22

Primary completion

2018-03-08

Completion

2018-03-08

Outcome

Missed primary endpoint

paper non-inferiority was not supported statistically, as the upper bound of the confidence interval exceeded our pre-specified non-inferiority margin (1.25). PMID 35971297 ↗

Publications

• Nikoo M, Kianpoor K, Nikoo N, Javidanbardan S, Kazemi A, Choi F, Vogel M, Gholami A, Tavakoli S, Wong JSH, Moazen-Zadeh E, Givaki R, Jazani M, Mohammadian F, Moghaddam NM, Schutz C, Jang K, Akhondzadeh S, Krausz M. Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial. Addiction. 2023 Feb;118(2):284-294. doi: 10.1111/add.16030. Epub 2022 Sep 7.
• Nikoo M, Moazen-Zadeh E, Nikoo N, Javidanbardan S, Kazemi A, Choi F, Vogel M, Gholami A, Tavakoli S, Givaki R, Jazani M, Mohammadian F, Markazi Moghaddam N, Goudarzi N, Schutz C, Jang K, Akhondzadeh S, Krausz M. 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.

Drugs

Indications