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Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Yale University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00023283
First received: August 30, 2001
Last updated: December 30, 2008
Last verified: December 2008
History of Changes
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Heroin
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 0
Arms Assigned Interventions
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

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
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Yale University
Investigators
Principal Investigator: Richard Schottenfeld, M.D. Yale University
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Schottenfeld, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00023283     History of Changes
Other Study ID Numbers: NIDA-9803-1, R01-9803-1
Study First Received: August 30, 2001
Last Updated: December 30, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013