NCT01189305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

4.6 years

First QC Date

August 16, 2010

Last Update Submit

March 19, 2015

Conditions

Drug Abuse

Keywords

Drug AbuseFemale Patients

Outcome Measures

Primary Outcomes (1)

  • percent days abstinent from illicit drugs

    12 months

Study Arms (2)

Behavioral Couples Therapy

EXPERIMENTAL
Behavioral: Behavioral Couples Therapy

Individual Drug Counseling

EXPERIMENTAL
Behavioral: Individual Drug Counseling

Interventions

Behavioral Couples TherapyBEHAVIORAL

Behavioral Couples Therapy

Behavioral Couples Therapy
Individual Drug CounselingBEHAVIORAL

Individual Drug Counseling

Individual Drug Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • both patient and partner without severe mental health disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdCare Hospital of Worcester Inc.

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Timothy J O'Farrell, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 26, 2010

Study Start

July 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

US(1)