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Completed

NCT Number: NCT01131273

HIV Risk Reduction in Subutex Injectors in Tbilisi

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Union Alternative Georgia

Tbilisi, 0186, Georgia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methadone

Drug

12 weeks of methadone maintenance with counseling

buprenorphine-naloxone (Suboxone) for 12 weeks

Drug

12 weeks of maintenance with counseling

Primary outcomes

  1. Buprenorphine injecting

    Time frame: 12 weeks

    • 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 outcomes

  1. HIV Risk

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 26, 2010
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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