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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: clinic-based care with buprenorphine (clinic-based BPN/NX arm); or case management and referral to an opioid treatment program for opioid agonist-based therapy (case management and referral arm). The study interventions and follow-up will last 12 months. Participants will be enrolled over a 3-year period. Participants who are assigned to the clinic-based BPN/NX arm will receive BPN/NX (Suboxone®), individual counseling from a nurse interventionist, and group therapy sessions. Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic (Project LINK). LINK provides intensive case management, education, and support by a team that includes a social worker, a nurse, a pharmacist educator, and peer advocates. In addition to providing counseling and linkage to needed services, LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence. The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months. The case-management and referral arm represents standard-of-care in our clinic, which has been enhanced and codified for this trial. Study outcome visits will be performed at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months. Comparisons: Retention to substance abuse treatment; Urine drug screens; Adherence to HIV primary care provider visits; Use of and adherence to highly active antiretroviral therapy (HAART); HIV RNA levels and CD4 cell counts; HIV transmission risk behaviors (e.g., injection, sharing of drug paraphernalia, sexual behaviors); Costs and resource utilization.

Official Title
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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

Conditions
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Opiate Dependence, HIV Seropositivity, HIV Infections

Intervention / Treatment
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* Behavioral: Clinic-based substance abuse treatment with buprenorphine
* Behavioral: Case management and referred substance abuse treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic | Behavioral: Clinic-based substance abuse treatment with buprenorphine<br>* Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic<br>|
| Active Comparator: 2<br>Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence | Behavioral: Case management and referred substance abuse treatment<br>* Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention to substance abuse treatment |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visit attendance with primary medical provider |  | 12 months | 
| Urine drug screen positivity for opioids and other drugs |  | 12 months | 
| Use of and adherence to highly active antiretroviral therapy (HAART) |  | 12 months | 
| HIV RNA changes |  | 12 months | 
| CD4 cell count changes |  | 12 months | 
| Self-reported HIV transmission risk behaviors |  | 12 months | 
| Costs and resource utilization |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Dependence, Opiate Dependence, Human Immunodeficiency Viruses, Buprenorphine