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Sponsors and Collaborators: |
University of Miami HRSA/Maternal and Child Health Bureau National Institute on Drug Abuse (NIDA) |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00348868 |
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.
Condition | Intervention |
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HIV Infection Opioid-Related Disorders |
Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling Behavioral: Standard counseling |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Miami Buprenorphine HIV Care Integration Project |
Enrollment: | 10 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
enhanced behavioral motivation counseling
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Behavioral: enhanced behavioral motivation counseling Behavioral: Motivational counseling |
2: Active Comparator | Behavioral: Standard counseling |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Miami AIDS Clinical Reserach Unit | |
Miami, Florida, United States, 33136 |
Principal Investigator: | Margaret Fischl, M.D. | University of Miami |
Responsible Party: | Unversity of Miami ( Margaret A. Fischl, M.D. ) |
Study ID Numbers: | A007 |
Study First Received: | July 5, 2006 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00348868 |
Health Authority: | United States: Institutional Review Board |
HIV Infection Opioid dependence DSM-IV criteria for opioid dependence |
Virus Diseases Buprenorphine Sexually Transmitted Diseases, Viral Mental Disorders HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Infection |
Pharmacologic Actions Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |