Behavioral Couples Therapy for Female Drug-Abusing Patients

Drug Abuse Clinical Trial

— CPW-D  

Official title:

Behavioral Couples Therapy for Female Drug-Abusing Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189305
• Other study ID #: 1R01DA025618
• Secondary ID: 1R01DA025618
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2010
• Last updated: March 19, 2015
• Start date: July 2009
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Abuse

Intervention

Behavioral:
• Behavioral Couples Therapy
Behavioral Couples Therapy
• Individual Drug Counseling
Individual Drug Counseling

Locations

Country	Name	City	State
United States	AdCare Hospital of Worcester Inc.	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent days abstinent from illicit drugs		12 months	No