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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 : Completed
First Posted : August 31, 2001
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University

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)

Condition or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous Drug: Buprenorphine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
Study Start Date : August 2000
Actual Primary Completion Date : December 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Standard Medical Management with once-weekly medication dispensing
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: 2
Standard Medical Management with thrice-weekly medication dispensing
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: 3
Enhanced Medical Management with thrice-weekly medication dispensing
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




Primary Outcome Measures :
  1. Self-reported frequency of illicit opioid use [ Time Frame: 6 months ]
  2. Percentage of opioid-negative urine specimens [ Time Frame: 6 months ]
  3. Maximum number of weeks abstinent from illicit opioids [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023283


Locations
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United States, Connecticut
APT Residential Services Division
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Richard Schottenfeld, M.D. Yale University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard S. Schottenfeld, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00023283    
Other Study ID Numbers: NIDA-9803-1
R01DA009803 ( U.S. NIH Grant/Contract )
R01-9803-1
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Keywords provided by Yale University:
Opioid-Related Disorders
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists