- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189305
Behavioral Couples Therapy for Female Drug-Abusing Patients (CPW-D)
March 19, 2015 updated by: Timothy J. O'Farrell, Harvard University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
185
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- AdCare Hospital of Worcester Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Couples Therapy
|
Behavioral Couples Therapy
|
|
Experimental: Individual Drug Counseling
|
Individual Drug Counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
percent days abstinent from illicit drugs
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy J O'Farrell, PhD, Harvard University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
August 16, 2010
First Submitted That Met QC Criteria
August 25, 2010
First Posted (Estimate)
August 26, 2010
Study Record Updates
Last Update Posted (Estimate)
March 23, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA025618 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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