- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131273
HIV Risk Reduction in Subutex Injectors in Tbilisi
August 17, 2016 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tbilisi, Georgia, 0186
- Union Alternative Georgia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Methadone maintenance for 12 weeks
Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
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12 weeks of methadone maintenance with counseling
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ACTIVE_COMPARATOR: buprenorphine-naloxone (Suboxone)
12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling
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12 weeks of maintenance with counseling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Risk
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Geroge Woody, MD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
April 8, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (ESTIMATE)
May 26, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Respiratory System Agents
- Antitussive Agents
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
- Methadone
Other Study ID Numbers
- RDA026754A
- DPMC (Other Identifier: NIDA)
- R21DA026754 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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