Trial record 4 of 9 for:    " November 26, 2006":" December 03, 2006"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Brief Introductory Therapy for Opioid Dependence

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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

  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
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
Investigators
Principal Investigator: Marek C Chawarski, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Marek Cezary Chawarski, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00406484     History of Changes
Other Study ID Numbers: 2 R01 DA013108-04
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
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
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014