HIV Risk Reduction in Subutex Injectors in Tbilisi

University of Pennsylvania68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

methadoneDRUG

12 weeks of methadone maintenance with counseling

buprenorphine-naloxone (Suboxone) for 12 weeksDRUG

12 weeks of maintenance with counseling

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Union Alternative Georgia

Tbilisi, Georgia

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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