Behavioral Couples Therapy for Female Drug-Abusing Patients | NCT01189305

Studies
Behavioral Couples Therapy for Female Drug-Abusing Patients

NCT01189305

Sponsor

Harvard University

Status

Completed

Last Update Posted

Mar 23, 2015Estimated

Enrollment

185Actual

Phase

Phase 2

Conditions

Drug Abuse

Interventions

Behavioral Couples Therapy
Individual Drug Counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01DA025618	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Aug 16, 2010

First Submission Date that Met QC Criteria

Aug 25, 2010

First Posted Date

Aug 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2015

Last Update Posted Date

Mar 23, 2015Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

185Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Behavioral Couples Therapy	Experimental		Behavioral: Behavioral Couples Therapy
Individual Drug Counseling	Experimental		Behavioral: Individual Drug Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioral Couples Therapy	Behavioral	Behavioral Couples Therapy	Behavioral Couples Therapy

Measure	Description	Time Frame
percent days abstinent from illicit drugs		12 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy J O'Farrell, PhD	Harvard University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AdCare Hospital of Worcester Inc.		Worcester	Massachusetts	01605	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided