HIV Infections Clinical Trial
Official title:
Buprenorphine Effectiveness Evaluation in HIV Enhancement (BEEHIVE): A Randomized Trial of HIV Clinic-based Buprenorphine/Naloxone vs. Case Management and Referral in Opioid-dependent Individuals
Verified date | April 2009 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins HIV Clinic | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | The New York Academy of Medicine |
United States,
Lucas GM, Chaudhry A, Hsu J, Woodson T, Lau B, Olsen Y, Keruly JC, Fiellin DA, Finkelstein R, Barditch-Crovo P, Cook K, Moore RD. Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention to substance abuse treatment | 12 months | No | |
Secondary | Visit attendance with primary medical provider | 12 months | No | |
Secondary | Urine drug screen positivity for opioids and other drugs | 12 months | No | |
Secondary | Use of and adherence to highly active antiretroviral therapy (HAART) | 12 months | No | |
Secondary | HIV RNA changes | 12 months | No | |
Secondary | CD4 cell count changes | 12 months | No | |
Secondary | Self-reported HIV transmission risk behaviors | 12 months | No | |
Secondary | Costs and resource utilization | 12 months | No |
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