Status:
COMPLETED
Buprenorphine HIV Care Integration Project
Lead Sponsor:
University of Miami
Collaborating Sponsors:
HRSA/Maternal and Child Health Bureau
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infection
Opioid-Related Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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/n...
Eligibility Criteria
Inclusion
- HIV infection
- 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
- Serious medical problem
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00348868
Start Date
July 1 2006
End Date
December 1 2007
Last Update
March 18 2008
Active Locations (1)
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1
University of Miami AIDS Clinical Reserach Unit
Miami, Florida, United States, 33136