Women's Treatment for Trauma and Substance Use Disorders - 1

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00078156

First received: February 19, 2004

Last updated: January 11, 2017

Last verified: October 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2004

Last Updated Date

January 11, 2017

Start Date ^ICMJE

January 2004

Primary Completion Date

October 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Drug abstinence

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00078156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Women's Treatment for Trauma and Substance Use Disorders - 1

Official Title ^ICMJE

Women's Treatment for Trauma and Substance Use Disorders

Brief Summary

The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Substance-Related Disorders

Intervention ^ICMJE

Behavioral: Behavior Therapy

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

409

Estimated Completion Date

October 2005

Primary Completion Date

October 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria - Women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD.

Exclusion Criteria:

- Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years to 99 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00078156

Other Study ID Numbers ^ICMJE

NIDA-CTN-0015-1

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Denise Hien, Ph.D., New York State Psychiatric Institute

Study Sponsor ^ICMJE

New York State Psychiatric Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Denise Hien, Ph.D.

New York State Psychiatric Institute

PRS Account

National Institute on Drug Abuse (NIDA)

Verification Date

October 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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