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HIV Risk Reduction in Subutex Injectors in Tbilisi

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131273
First Posted: May 26, 2010
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Buprenorphine injecting [ Time Frame: 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 Outcome Measures:
  • 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.


Enrollment: 68
Study Start Date: June 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01131273     History of Changes
Other Study ID Numbers: RDA026754A
R21DA026754 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: April 8, 2010
First Posted: May 26, 2010
Last Update Posted: August 19, 2016
Last Verified: August 2016

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
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents


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