HIV Risk Reduction in Subutex Injectors in Tbilisi

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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

April 8, 2010
January 17, 2012
June 2010
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01131273 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
HIV Risk Reduction in Subutex Injectors in Tbilisi
Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: methadone
    12 weeks of methadone maintenance with counseling
  • Drug: buprenorphine-naloxone (Suboxone) for 12 weeks
    12 weeks of maintenance with counseling
  • Active Comparator: Methadone maintenance for 12 weeks
    Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
    Intervention: Drug: methadone
  • Active Comparator: buprenorphine-naloxone (Suboxone)
    12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling
    Intervention: Drug: buprenorphine-naloxone (Suboxone) for 12 weeks
Otiashvili D, Piralishvili G, Sikharulidze Z, Kamkamidze G, Poole S, Woody GE. Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend. 2013 Dec 1;133(2):376-82. doi: 10.1016/j.drugalcdep.2013.06.024. Epub 2013 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
September 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Georgia
 
NCT01131273
RDA026754A, R21DA026754, DPMC
No
University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Study Director: Geroge Woody, MD University of Pennsylvania
University of Pennsylvania
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP