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HIV Risk Reduction in Subutex Injectors in Tbilisi

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01131273
First received: April 8, 2010
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
 Drug: methadone
Drug: buprenorphine-naloxone (Suboxone) for 12 weeks
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Buprenorphine injecting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • HIV Risk [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone maintenance for 12 weeks
Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
 Drug: methadone
12 weeks of methadone maintenance with counseling
Active Comparator: buprenorphine-naloxone (Suboxone)
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
12 weeks of maintenance with counseling

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131273

Locations
Georgia
Union Alternative Georgia
Tbilisi, Georgia, 0186
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Study Director: Geroge Woody, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01131273     History of Changes
Other Study ID Numbers: RDA026754A, R21DA026754, DPMC
Study First Received: April 8, 2010
Last Updated: January 17, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
buprenorphine injecting
opiate dependence
HIV risk
treatment outcome
opiate dependence with buprenorphine injecting

Additional relevant MeSH terms:
Buprenorphine
Methadone
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013