HIV Risk Reduction in Subutex Injectors in Tbilisi

Study Overview
=================
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.

Official Title
-----------------
Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: methadone
* Drug: buprenorphine-naloxone (Suboxone) for 12 weeks


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methadone maintenance for 12 weeks<br>Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone. | Drug: methadone<br>* 12 weeks of methadone maintenance with counseling<br>|
| Active Comparator: buprenorphine-naloxone (Suboxone)<br>12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling | Drug: buprenorphine-naloxone (Suboxone) for 12 weeks<br>* 12 weeks of maintenance with counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buprenorphine injecting | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Risk | 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
buprenorphine injecting, opiate dependence, HIV risk, treatment outcome, opiate dependence with buprenorphine injecting