Clinical Trials

MainTitle

HIV Risk Reduction in Subutex Injectors in Tbilisi

This study has been completed
Sponsor
University of Pennsylvania

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: August 17, 2016
Last Verified: August 2016
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 25 Years to 50 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


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: August 17, 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

ClinicalTrials.gov processed this data on December 12, 2017
This information is provided by ClinicalTrials.gov.