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

NCT02502175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2019-07-12

No results posted yet for this study

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.

Conditions

  • Opioid Dependence

Interventions

DRUG

opium

Opium tincture (10mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.

DRUG

methadone

Methadone (5mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    collaborator OTHER

  • Iran National Science Foundation

    collaborator UNKNOWN

  • AJA University of Medical Sciences

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Michael R Kausz, MD, PhD · University of British Columbia

  • Shahin Akhondzadeh, PhD · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2018-03-08
Completion
2018-03-08

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502175 on ClinicalTrials.gov