Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00023283

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Location

Arms

Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous	Drug: Buprenorphine	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Standard Medical Management with once-weekly medication dispensing	Drug: Buprenorphine 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
Experimental: 2 Standard Medical Management with thrice-weekly medication dispensing	Drug: Buprenorphine 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
Experimental: 3 Enhanced Medical Management with thrice-weekly medication dispensing	Drug: Buprenorphine 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

Arm

Intervention/Treatment

Experimental: 1

Standard Medical Management with once-weekly medication dispensing

Drug: Buprenorphine

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

Experimental: 2

Standard Medical Management with thrice-weekly medication dispensing

Drug: Buprenorphine

Experimental: 3

Enhanced Medical Management with thrice-weekly medication dispensing

Drug: Buprenorphine

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.