Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants

Completed · Phase 2

Conditions studied: Opiate Dependence, HIV Seropositivity, HIV Infections

In brief

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 approaches are: * Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence (e.g., methadone or buprenorphine); or * Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic.

Key facts

Study ID

NCT00130819

Run by

Johns Hopkins University

People needed

120

Starts

2005-11-01

Expected to finish

2009-04-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins HIV Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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