Behavioral Couples Therapy for Female Drug-Abusing Patients (CPW-D)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Harvard University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Timothy J. O'Farrell, Harvard University
ClinicalTrials.gov Identifier:
NCT01189305
First received: August 16, 2010
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.


Condition Intervention Phase
Drug Abuse
Behavioral: Behavioral Couples Therapy
Behavioral: Individual Drug Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Couples Therapy for Female Drug-Abusing Patients

Further study details as provided by Harvard University:

Primary Outcome Measures:
  • percent days abstinent from illicit drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Couples Therapy Behavioral: Behavioral Couples Therapy
Behavioral Couples Therapy
Experimental: Individual Drug Counseling Behavioral: Individual Drug Counseling
Individual Drug Counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female patients with primary drug abuse diagnosis & their relationship partners
  • patient married or cohabiting with relationship partner
  • partner without current alcohol or drug problem

Exclusion Criteria:

  • both patient and partner without severe mental health disorders
  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: NCT01189305

Contacts
Contact: Vyga Kaufmann, PhD 508-799-9000 ext 4043 vyga_kaufmann@hms.harvard.edu
Contact: Fay Larkin, MA 508-799-9000 ext 4043 fay_larkin@hms.harvard.edu

Locations
United States, Massachusetts
AdCare Hospital of Worcester Inc. Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Kaufmann, PhD    508-799-9000 ext 4043      
Sponsors and Collaborators
Harvard University
Investigators
Principal Investigator: Timothy J O'Farrell, PhD Harvard University
  More Information

No publications provided

Responsible Party: Timothy J. O'Farrell, Professor of Psychology, Harvard University
ClinicalTrials.gov Identifier: NCT01189305     History of Changes
Other Study ID Numbers: 1R01DA025618, 1R01DA025618
Study First Received: August 16, 2010
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard University:
Drug Abuse
Female Patients

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

ClinicalTrials.gov processed this record on July 31, 2014