Clinical Trials Directory

Trials / Completed

CompletedNCT00023283

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
Sponsor
Yale University · Academic / Other
Sex
All
Age
21 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBuprenorphine1. 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

Timeline

Start date
2000-08-01
Primary completion
2003-12-01
Completion
2004-02-01
First posted
2001-08-31
Last updated
2020-06-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00023283. Inclusion in this directory is not an endorsement.