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Brief Introductory Therapy for Opioid Dependence

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: NCT00406484
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Opiate Dependence HIV Infections Behavioral: Standard drug counseling Behavioral: BDRC Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Introductory Therapy for Opioid Dependence
Study Start Date : September 2004
Primary Completion Date : September 2009
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Maximum number of consecutive weeks of opiate abstinence achieved during treatment [ Time Frame: 12 weeks ]
  2. Overall proportion of opiate negative urines tests in each treatment group [ Time Frame: 12 weeks ]
  3. Reduction in HIV risk behaviors [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Improvements in social, employment, legal, medical and psychiatric functioning [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • opioid dependence

Exclusion Criteria:

  • suicide or homicide risk
  • psychiatric disorder requiring medication treatment
  • life threatening or unstable medical problems
Contacts and Locations

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): NCT00406484

United States, Connecticut
Methadone Research Unit, The APT Foundation, Inc.
New Haven, Connecticut, United States, 06519
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marek C Chawarski, Ph.D. Yale University
More Information

Responsible Party: Marek Cezary Chawarski, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00406484     History of Changes
Other Study ID Numbers: 2R01DA013108-04 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Keywords provided by Marek Cezary Chawarski, Yale University:
HIV risk reduction
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
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
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders