ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

This study is not yet open for participant recruitment.
Verified by National Institute on Drug Abuse (NIDA), December 2002

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Yale University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00023283
  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 Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Substance Abuse, Intravenous
Drug: Buprenorphine
Phase II

MedlinePlus related topics:   Heroin   

ChemIDplus related topics:   Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   0

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.

  Eligibility
Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023283

Contacts
Contact: Richard Schottenfeld, M.D.     (203)974-7349     richard.schottenfeld@yale.edu    

Locations
United States, Connecticut
APT Residential Services Division    
      New Haven, Connecticut, United States, 06519
      Contact: Richard Schottenfeld, M.D.     203-974-7349     richard.schottenfeld@yale.edu    

Sponsors and Collaborators

Investigators
Principal Investigator:     Richard Schottenfeld, M.D.     Yale University    
  More Information

Publications indexed to this study:

Study ID Numbers:   NIDA-9803-1, R01-9803-1
First Received:   August 30, 2001
Last Updated:   November 3, 2005
ClinicalTrials.gov Identifier:   NCT00023283
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Buprenorphine
Mental Disorders
Heroin Dependence
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders
Substance Abuse, Intravenous

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers