Women's Treatment for Trauma and Substance Use Disorders - 1
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00078156 |
Recruitment Status
:
Completed
First Posted
: February 23, 2004
Last Update Posted
: January 12, 2017
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Sponsor:
New York State Psychiatric Institute
Information provided by:
National Institute on Drug Abuse (NIDA)
Tracking Information | ||||
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First Submitted Date ICMJE | February 19, 2004 | |||
First Posted Date ICMJE | February 23, 2004 | |||
Last Update Posted Date | January 12, 2017 | |||
Study Start Date ICMJE | January 2004 | |||
Actual 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 * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
409 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | October 2005 | |||
Actual 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). |
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
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 | |||
IPD Sharing Statement | 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 |
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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 |