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| Sponsors and Collaborators: |
University of Miami HRSA/Maternal and Child Health Bureau National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | University of Miami |
| ClinicalTrials.gov Identifier: | NCT00348868 |
Purpose
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 |
|---|---|
|
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 |
|---|---|
|
1: Experimental
enhanced behavioral motivation counseling
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Miami AIDS Clinical Reserach Unit | |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: | Margaret Fischl, M.D. | University of Miami |
More Information
| 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 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV Infection Opioid dependence DSM-IV criteria for opioid dependence |
|
Sexually Transmitted Diseases, Viral Narcotic Antagonists Acquired Immunodeficiency Syndrome Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Immunologic Deficiency Syndromes Virus Diseases |
Buprenorphine HIV Infections Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Peripheral Nervous System Agents Analgesics Retroviridae Infections Analgesics, Opioid |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Narcotic Antagonists Physiological Effects of Drugs Disorders of Environmental Origin Opioid-Related Disorders Infection Buprenorphine Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Retroviridae Infections |
Analgesics, Opioid RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Narcotics Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |