HIV Risk Reduction in Subutex Injectors in Tbilisi

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Methadone; Naloxone

Criteria

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.