Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly drug-free programs.

Detailed Description
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This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly drug-free programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.

Official Title
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Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans

Conditions
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Drug Dependence

Intervention / Treatment
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* Behavioral: Outpatient
* Behavioral: Intensive Outpatient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: heroin-dependent adults new admissions to buprenorphine outpatient treatment Exclusion Criteria: pregnancy acute medical or psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Intensive Outpatient<br>Buprenorphine patients receiving 9 or more hours of outpatient counseling. | Behavioral: Intensive Outpatient<br>* Buprenorphine patients receiving 9 or more hours of outpatient counseling.<br>|
| Active Comparator: Outpatient<br>Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. | Behavioral: Outpatient<br>* Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) |  | 6 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, outpatient treatment, intensive outpatient treatment