Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2001

Last Updated Date

December 30, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Self-reported frequency of illicit opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percentage of opioid-negative urine specimens [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Maximum number of weeks abstinent from illicit opioids [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00023283 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Official Title ^ICMJE

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized

Condition ^ICMJE

Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous

Intervention ^ICMJE

Drug: Buprenorphine

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Richard Schottenfeld, M.D.

(203)974-7349

richard.schottenfeld@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00023283

Responsible Party

Richard S. Schottenfeld, MD, Yale University School of Medicine

Study ID Numbers ^ICMJE

NIDA-9803-1, R01-9803-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Yale University

Investigators ^ICMJE

Principal Investigator:

Richard Schottenfeld, M.D.

Yale University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP