HIV Risk Reduction in Subutex Injectors in Tbilisi

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: HIV

Treatments: Drug: buprenorphine-naloxone (Suboxone) for 12 weeks; Drug: methadone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01131273

R21DA026754 (U.S. NIH Grant/Contract)

DPMC

RDA026754A

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Methadone maintenance for 12 weeks

Active Comparator group

Description:

Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.

Treatment:

Drug: methadone

buprenorphine-naloxone (Suboxone)

Active Comparator group

Description:

12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling

Treatment:

Drug: buprenorphine-naloxone (Suboxone) for 12 weeks