Counseling Conditions for Buprenorphine in a Primary Care Clinic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-02-29

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)

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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.

Conditions

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Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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1

Standard Medical Management with once-weekly medication dispensing

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

1. Experimental Standard Medical Management with once-weekly medication dispensing
2. Experimental Standard Medical Management with thrice-weekly medication dispensing
3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

2

Standard Medical Management with thrice-weekly medication dispensing

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

1. Experimental Standard Medical Management with once-weekly medication dispensing
2. Experimental Standard Medical Management with thrice-weekly medication dispensing
3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

3

Enhanced Medical Management with thrice-weekly medication dispensing

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

1. Experimental Standard Medical Management with once-weekly medication dispensing
2. Experimental Standard Medical Management with thrice-weekly medication dispensing
3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

Interventions

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Buprenorphine

1. Experimental Standard Medical Management with once-weekly medication dispensing
2. Experimental Standard Medical Management with thrice-weekly medication dispensing
3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes