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Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

This study is not yet open for patient recruitment.

Sponsored by: National Institute on Drug Abuse (NIDA)
Yale University
Information provided by: National Institute on Drug Abuse (NIDA)

Purpose

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 Treatment or Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
 Drug: Buprenorphine
Phase II

MedlinePlus related topics:  Drug Abuse;   Heroin Abuse;   Prescription Drug Abuse

Study Type: Interventional
Study Design: Treatment, Randomized, Uncontrolled

Official Title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  21 Years   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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.


Location Information

Richard Schottenfeld, M.D.      (203)974-7349 

Connecticut
      APT Residential Services Division, New Haven,  Connecticut,  06519,  United States
Richard Schottenfeld, M.D.  203-974-7349 

Study chairs or principal investigators

Richard Schottenfeld, M.D.,  Principal Investigator,  Yale University   

More Information

Study ID Numbers:  NIDA-9803-1; R01-9803-1
Record last reviewed:  December 2002
Record first received:  August 30, 2001
ClinicalTrials.gov Identifier:  NCT00023283
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20
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