Buprenorphine HIV Care Integration Project

Study Overview
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Brief Summary
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A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.

Detailed Description
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DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting. DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years. SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks. POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection. STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care) INTERVENTON At entry subjects will be randomized to one of the following: ARM A: Standard drug addiction counseling + buprenorphine / naloxone ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone The three primary outcomes are: Cessation of illicit opioid use Reduction in high risk behavior Improved HIV therapy adherence

Official Title
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Miami Buprenorphine HIV Care Integration Project

Conditions
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HIV Infection, Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: enhanced behavioral motivation counseling
* Behavioral: Motivational counseling
* Behavioral: Standard counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection Receiving or seeking outpatient HIV care Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given Men and women age ≥ 18 years Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase <=5 X ULN, Total bilirubin <= 2.5 x ULN Exclusion Criteria: Serious medical problem Acute and/or severe psychiatric conditions High dose methadone (>30 mg/day) Documented co-dependence on alcohol and/or benzodiazepines, barbiturates Chronic pain management requiring opioids Pregnancy or breast-feeding Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical

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>enhanced behavioral motivation counseling | Behavioral: enhanced behavioral motivation counseling<br> <br> Behavioral: Motivational counseling<br> <br> |
| Active Comparator: 2<br> | Behavioral: Standard counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence |  | week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Infection, Opioid dependence, DSM-IV criteria for opioid dependence