Status:
COMPLETED
Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
State University of New York at Buffalo
University of Utah
Conditions:
Opioid Dependency
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the interactions of buprenorphine-naloxone, a medication used to treat opiate (heroin or prescription narcotic) dependence, and medications used in the treatmen...
Detailed Description
The overall objective of this project, RO1 DA 13004 "Opioids and HIV Medications: Interactions in Drug Abusers" and the supplement "Interaction of Buprenorphine and TB Medications," is to continue to ...
Eligibility Criteria
Inclusion
- Subjects will be in good health as determined by a physical examination and screening laboratory tests and urinalysis, and will meet the criteria of opioid dependence, but will not be physiologically dependent on any other drugs or alcohol; those with history of current binge alcohol use will also be excluded. Subjects will be enrolled in buprenorphine treatment and must be on a stable, standard clinical dose (4-20 mg/d) for at least 2 weeks prior to initiation of pharmacokinetics study.
- Control subjects who are non-opioid dependent, are not physiologically dependent on any other drugs or alcohol and volunteer for the HIV medications pharmacokinetics studies alone must be in good health as determined by a physical examination and screening laboratory studies as described below.
- Age 18 or older.
- Able to give voluntary, signed, informed consent.
Exclusion
- Patients who are receiving concurrently other drugs that are inducers or inhibitors of hepatic microsomal enzymes.
- Patients with a known sensitivity to the HIV therapeutics to be studied.
- Pregnant women or nursing mothers. All women who are sexually active and capable of becoming pregnant must have a negative pregnancy test within one week prior to entry into these studies.
- Major psychotic illness or suicidality.
- Clinically active hepatitis (primarily Hepatitis B or C in opioid dependent subjects) with liver enzyme elevations \> 3 times the upper limit of normal
- Those with diabetes, hyperlipidemia, coagulation disorders, or renal disease will be excluded.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00877591
Start Date
April 1 2008
End Date
April 1 2013
Last Update
May 6 2014
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110