Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Study Overview
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Brief Summary
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The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)

Detailed Description
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A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Official Title
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Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Conditions
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Heroin Dependence, Opioid-Related Disorders, Substance Abuse, Intravenous

Intervention / Treatment
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* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study. Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Standard Medical Management with once-weekly medication dispensing | Drug: Buprenorphine<br>* Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing<br>|
| Experimental: 2<br>Standard Medical Management with thrice-weekly medication dispensing | Drug: Buprenorphine<br>* Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing<br>|
| Experimental: 3<br>Enhanced Medical Management with thrice-weekly medication dispensing | Drug: Buprenorphine<br>* Experimental Standard Medical Management with once-weekly medication dispensing Experimental Standard Medical Management with thrice-weekly medication dispensing Experimental Enhanced Medical Management with thrice-weekly medication dispensing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported frequency of illicit opioid use |  | 6 months | 
| Percentage of opioid-negative urine specimens |  | 6 months | 
| Maximum number of weeks abstinent from illicit opioids |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-Related Disorders