HIV Risk Reduction in Subutex Injectors in Tbilisi

HIV Clinical Trial

Official title:

Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131273
• Other study ID #: RDA026754A
• Secondary ID: R21DA026754DPMC
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2010
• Last updated: August 17, 2016
• Start date: June 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• methadone
12 weeks of methadone maintenance with counseling
• buprenorphine-naloxone (Suboxone) for 12 weeks
12 weeks of maintenance with counseling

Locations

Country	Name	City	State
Georgia	Union Alternative Georgia	Tbilisi

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes