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
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
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.