Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Opioid-Related Disorders Clinical Trial

Official title:

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023283
• Other study ID #: NIDA-9803-1
• Secondary ID: R01DA009803R01-9
• Status: Completed
• Phase: Phase 2
• Start date: August 2000
• Est. completion date: February 2004

Study information

• Verified date: June 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders
• Substance Abuse, Intravenous
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	APT Residential Services Division	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported frequency of illicit opioid use		6 months
Primary	Percentage of opioid-negative urine specimens		6 months
Primary	Maximum number of weeks abstinent from illicit opioids		6 months