Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2006-07-31
2007-12-31
Brief Summary
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Detailed Description
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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:
1. Cessation of illicit opioid use
2. Reduction in high risk behavior
3. Improved HIV therapy adherence
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
enhanced behavioral motivation counseling
enhanced behavioral motivation counseling
Motivational counseling
2
Standard counseling
Interventions
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enhanced behavioral motivation counseling
Motivational counseling
Standard counseling
Eligibility Criteria
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Inclusion Criteria
* Receiving or seeking outpatient HIV care
* Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
* Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
* Men and women age ≥ 18 years
* Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine
* Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase \<=5 X ULN, Total bilirubin \<= 2.5 x ULN
Exclusion Criteria
* Acute and/or severe psychiatric conditions
* High dose methadone (\>30 mg/day)
* Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
* Chronic pain management requiring opioids
* Pregnancy or breast-feeding
* Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical
18 Years
ALL
No
Sponsors
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HRSA/Maternal and Child Health Bureau
FED
National Institute on Drug Abuse (NIDA)
NIH
University of Miami
OTHER
Responsible Party
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Unversity of Miami
Principal Investigators
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Margaret Fischl, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami AIDS Clinical Reserach Unit
Miami, Florida, United States
Countries
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Other Identifiers
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A007
Identifier Type: -
Identifier Source: org_study_id