Buprenorphine and Integrated HIV Care

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

Detailed Description
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The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials. From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.

Official Title
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On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings

Conditions
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Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus, AIDS, HIV Infections

Intervention / Treatment
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* Other: Physician Management
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV disease DSM-IV criteria for opioid dependence, as assessed by SCID Documented opioid positive urine toxicology testing Exclusion criteria: Desire to remain enrolled in opioid agonist treatment at an opioid treatment program Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded) Current suicide or homicide risk Current psychotic disorder or major depression Inability to read or understand English Dementia Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement Currently enrolled in other studies involving the provision of psychosocial treatment.

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 |
| --- | --- |
| Active Comparator: 1<br>Physician Management | Other: Physician Management<br>* Standard physician care<br>|
| Experimental: 2<br>Physician Management and counseling (drug counseling and medication adherence) | Behavioral: Counseling<br>* Physician Management and Counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention |  | 52 weeks | 
| Reductions in illicit opioid use |  | 52 weeks | 
| Adherence to antiretroviral medications |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-lymphocyte CD4 cell count |  | 52 weeks | 
| HIV-1 RNA levels |  | 52 weeks | 
| Reduction in HIV transmission risk behaviors |  | 52 weeks | 
| Improved health status |  | 52 weeks | 
| Patient satisfaction |  | 52 weeks | 
| Provider satisfaction |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction