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Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00023283
Recruitment Status : Unknown
Verified December 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2001
Last Update Posted : January 1, 2009
Sponsor:
Collaborator:
Information provided by:

August 30, 2001
August 31, 2001
January 1, 2009
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  • Self-reported frequency of illicit opioid use [ Time Frame: 6 months ]
  • Percentage of opioid-negative urine specimens [ Time Frame: 6 months ]
  • Maximum number of weeks abstinent from illicit opioids [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT00023283 on ClinicalTrials.gov Archive Site
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Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
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)
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.
Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Heroin Dependence
  • Opioid-Related Disorders
  • Substance Abuse, Intravenous
Drug: Buprenorphine
  1. Experimental Standard Medical Management with once-weekly medication dispensing
  2. Experimental Standard Medical Management with thrice-weekly medication dispensing
  3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
  • Experimental: 1
    Standard Medical Management with once-weekly medication dispensing
    Intervention: Drug: Buprenorphine
  • Experimental: 2
    Standard Medical Management with thrice-weekly medication dispensing
    Intervention: Drug: Buprenorphine
  • Experimental: 3
    Enhanced Medical Management with thrice-weekly medication dispensing
    Intervention: Drug: Buprenorphine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
0
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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.

Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00023283
NIDA-9803-1
R01-9803-1
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Richard S. Schottenfeld, MD, Yale University School of Medicine
National Institute on Drug Abuse (NIDA)
Yale University
Principal Investigator: Richard Schottenfeld, M.D. Yale University
National Institute on Drug Abuse (NIDA)
December 2008

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