HIV Risk Reduction in Subutex Injectors in Tbilisi

Phase 3

Completed

• Conditions: HIV
• Interventions: Drug: methadone; Drug: buprenorphine-naloxone (Suboxone) for 12 weeks

• Registration Number: NCT01131273
• Lead Sponsor: University of Pennsylvania

Brief Summary

This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Study Start: 2010-06
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• current opioid dependence;
• injecting buprenorphine 10 or more times in the last 30 days;
• between 25 and 50 years of age;
• buprenorphine and/or opiate positive urine test;
• not on methadone maintenance in last 4 weeks;
• stable address within Tbilisi and not planning to move;
• home or cellular phone number where can be reached;
• able to provide name of family member who knows whereabouts;
• willingness and ability to give informed consent.

Exclusion Criteria

• currently dependent on alcohol, benzodiazepines or other CNS depressants;
• legan charges with impending incarceration;
• plans to move from Tbilisi within next 6 months;
• current participation in another treatment study;
• serious medical problems that would impair or make hazardous ability to participate;
• active TB;
• currently psychotic/suicidal;
• uncontrolled seizure disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone maintenance for 12 weeks	methadone	Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
buprenorphine-naloxone (Suboxone)	buprenorphine-naloxone (Suboxone) for 12 weeks	12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling

Primary Outcome Measures

Name	Time	Method
Buprenorphine injecting	12 weeks	1) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex. 2) obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone.

Secondary Outcome Measures

Name	Time	Method
HIV Risk	12 weeks	Obtain pilot data on the degree to which a 12-week course of suboxone or methadone reduces illegal activities and improves employment, psychiatric symptoms, overall adjustment and assess the prevalence of HIV, HEP B/C among study patients at week 20.

Trial Locations

Locations (1)

Union Alternative Georgia; 🇬🇪 Tbilisi, Georgia