Brief Introductory Therapy for Opioid Dependence

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Marek Cezary Chawarski, Yale University

ClinicalTrials.gov Identifier:

NCT00406484

First received: November 30, 2006

Last updated: January 15, 2014

Last verified: January 2014

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 ]


Enrollment:	51
Study Start Date:	September 2004
Study Completion Date:	September 2010
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406484

Locations


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)

Investigators


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
Study First Received:	November 30, 2006
Last Updated:	January 15, 2014
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 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

ClinicalTrials.gov processed this record on September 28, 2016

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