Comparison of opioid maintenance treatments (OMTs) in priso

Phase 3

Recruiting

• Conditions: Opioid dependence; F11.2; Moderate to severe opioids use disorder.

• Registration Number: IRCT20170702034844N7
• Lead Sponsor: Faran Shimi Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Diagnosis of moderate to severe opioid use disorder based on DSM-5
Continuous consumption of illegal opioids in the past month prior to incarceration
Age 18 to 50 years
Informed written consent to enter the study
Conviction period more than 6 months

Exclusion Criteria

Concurrent diagnosis of other substance use disorders (except tobacco)
Uncontrolled severe psychiatric disorders including serious suicidality or psychosis based on a study physician's diagnosis
Severe and uncontrolled physical conditions including unstable angina, liver failure and a history of myocardial infarction during last month based on physician' s diagnosis and laboratory evaluations
Inability to understand the study protocol or respond to study assessments
More than three times raise of liver enzymes

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of negative morphine urine tests. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Rapid morphine urine test.

Secondary Outcome Measures

Name	Time	Method
Retention in treatment. Timepoint: Baseline assessment and then weekly during study. Method of measurement: Continuous referrals to receive study medications and physician's visit.