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

• Status: Completed
• Trial end date: 2018-03-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: AJA University of Medical Sciences; Iran National Science Foundation; Tehran University of Medical Sciences
• Treatments: Analgesics, Opioid; Methadone; Opium

Criteria

Inclusion Criteria:

• Opioid dependence as confirmed by DSM V diagnostic criteria

• Willingness and ability to adhere to study protocol and follow-up schedule as determined through the pre-randomization period

• Provide written informed consent.

• Females of childbearing capacity must agree to use an acceptable method of birth control approved by the study investigator throughout the study.

Exclusion Criteria:

• Active participant in another treatment program for opioid dependence within 14 days before inclusion in the study

• Severe hepatic impairment (decompensated liver disease), a contraindication for methadone and its potential to precipitate hepatic encephalopathy.

• Hypersensitivity to methadone syrup or other ingredients in the formulation

• Pregnancy

• Severe chronic respiratory disease

• Head injury and raised intracranial pressure: Respiratory depressant effects (with CO2 retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, or a preexisting increase in intracranial pressure. May produce effects that obscure the clinical course in participants with head injuries.

• Biliary tract disease: may cause constriction of sphincter of Oddi.

• Monoamine oxidase inhibitors use within 14 days of the study