HIV Risk Reduction in Subutex Injectors in Tbilisi

Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131273

Enrollment

Registered

2010-05-26

Start date

2010-06-30

Completion date

2013-08-31

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

buprenorphine injecting, opiate dependence, HIV risk, treatment outcome, opiate dependence with buprenorphine injecting

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.

Interventions

DRUGmethadone

12 weeks of methadone maintenance with counseling

DRUGbuprenorphine-naloxone (Suboxone) for 12 weeks

12 weeks of maintenance with counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Georgia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026