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Brief Introductory Therapy for Opioid Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00406484
First received: November 30, 2006
Last updated: June 3, 2009
Last verified: June 2009
History of Changes
  Purpose

A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling.


Condition Intervention Phase
Opiate Dependence
HIV Infections
 Behavioral: Standard drug counseling
Behavioral: BDRC
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Introductory Therapy for Opioid Dependence

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Maximum number of consecutive weeks of opiate abstinence achieved during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Overall proportion of opiate negative urines tests in each treatment group [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reduction in HIV risk behaviors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvements in social, employment, legal, medical and psychiatric functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2004
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
 Behavioral: BDRC
Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions
Active Comparator: 2
Standard drug counseling
 Behavioral: Standard drug counseling
Individual drug counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • opioid dependence

Exclusion Criteria:

  • suicide or homicide risk
  • psychiatric disorder requiring medication treatment
  • life threatening or unstable medical problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406484

Contacts
Contact: Carolyn Haller 203-974-7349 carolyn.haller@yale.edu
Contact: Marek C Chawarksi, Ph.D. 203-974-7602 marek.chawarski@yale.edu

Locations
United States, Connecticut
Methadone Research Unit, The APT Foundation, Inc. Recruiting
New Haven, Connecticut, United States, 06519
Contact: Declan Barry, Ph.D.     203-781-4650 ext 268     declan.barry@yale.edu    
Sub-Investigator: Declan Barry, Ph.D.            
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Marek C Chawarski, Ph.D.     203-974-7602     marek.chawarski@yale.edu    
Sub-Investigator: Richard S Schottenfeld, M.D.            
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marek C Chawarski, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Marek C. Chawarski, Ph.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00406484     History of Changes
Other Study ID Numbers: 2 R01 DA013108-04
Study First Received: November 30, 2006
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Methadone
Counseling
HIV risk reduction
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Substance-Related Disorders
Mental Disorders
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

ClinicalTrials.gov processed this record on May 16, 2013