Buprenorphine HIV Care Integration Project
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|ClinicalTrials.gov Identifier: NCT00348868|
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : March 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Opioid-Related Disorders||Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling Behavioral: Standard counseling||Not Applicable|
DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
- Cessation of illicit opioid use
- Reduction in high risk behavior
- Improved HIV therapy adherence
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Miami Buprenorphine HIV Care Integration Project|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
enhanced behavioral motivation counseling
|Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling|
|Active Comparator: 2||Behavioral: Standard counseling|
- The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence [ Time Frame: week 48 ]
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): NCT00348868
|United States, Florida|
|University of Miami AIDS Clinical Reserach Unit|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Margaret Fischl, M.D.||University of Miami|