HIV Risk Reduction in Subutex Injectors in Tbilisi
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|ClinicalTrials.gov Identifier: NCT01131273|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: methadone Drug: buprenorphine-naloxone (Suboxone) for 12 weeks||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Methadone maintenance for 12 weeks
Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
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
- 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.
- 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.
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
|Union Alternative Georgia|
|Tbilisi, Georgia, 0186|
|Study Director:||Geroge Woody, MD||University of Pennsylvania|