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Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Phase 2
Completed
Conditions
Heroin Dependence
Substance Abuse, Intravenous
Opioid-Related Disorders
Interventions
Registration Number
NCT00023283
Lead Sponsor
Yale University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1BuprenorphineStandard Medical Management with once-weekly medication dispensing
2BuprenorphineStandard Medical Management with thrice-weekly medication dispensing
3BuprenorphineEnhanced Medical Management with thrice-weekly medication dispensing
Primary Outcome Measures
NameTimeMethod
Self-reported frequency of illicit opioid use6 months
Percentage of opioid-negative urine specimens6 months
Maximum number of weeks abstinent from illicit opioids6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

APT Residential Services Division

🇺🇸

New Haven, Connecticut, United States

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