Status:
COMPLETED
Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
The New York Academy of Medicine
Conditions:
Opiate Dependence
HIV Seropositivity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic. The two appro...
Detailed Description
We, the investigators at Johns Hopkins University, propose to enroll and randomize 120 opioid-dependent, HIV-infected participants, who receive care in the Johns Hopkins HIV Clinic to either: * clini...
Eligibility Criteria
Inclusion
- HIV-infected and receiving continuity care in the Johns Hopkins HIV Clinic
- 18 years of age or older
- Meets DSM-IV criteria for opioid dependence
- Seeks agonist-based treatment for opioid dependence
- Willing and able to provide written informed consent
- Willing to be contacted by mail and telephone for study follow-up visit reminders
- Willing to authorize release of information for substance abuse treatment to the study for a period of 12 months
- If female, negative urine pregnancy test and willingness to practice birth control while on study if sexually active (barrier method or progesterone-containing contraception product)
- Verbal approval from participant's primary HIV clinician
Exclusion
- Currently receiving methadone, naloxone, buprenorphine, or levomethadyl acetate (LAAM) as part of a licensed opioid treatment program
- History of allergic reaction to buprenorphine or naloxone
- Active medical need for opioid-based pain control
- Active benzodiazepine abuse or dependence
- Active alcohol dependence
- Alanine aminotransferase level that is more than 5 times the upper limit of normal
- Other condition that, in the opinion of the principal investigator, makes participation in the study unsafe or follow-up highly unlikely
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00130819
Start Date
November 1 2005
End Date
April 1 2009
Last Update
April 15 2015
Active Locations (1)
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1
Johns Hopkins HIV Clinic
Baltimore, Maryland, United States, 21287