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

Tracking Information
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; (submitted: August 2, 2005)	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 *	Resko SM, Brown S, Mendoza NS, Crosby S, González-Prendes A. Perceived Treatment Needs Among Women With Co-occurring Substance Use Disorders and PTSD. J Dual Diagn. 2016 Jul-Dec;12(3-4):271-281. Epub 2016 Oct 14.; López-Castro T, Hu MC, Papini S, Ruglass LM, Hien DA. Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders. Drug Alcohol Rev. 2015 May;34(3):242-51. doi: 10.1111/dar.12230. Epub 2015 Mar 4.; Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L, Patock-Peckham JA, Bainter SC. Indirect effects of 12-session seeking safety on substance use outcomes: overall and attendance class-specific effects. Am J Addict. 2014 May-Jun;23(3):218-25. doi: 10.1111/j.1521-0391.2014.12100.x.; Ruglass LM, Hien DA, Hu MC, Campbell AN. Associations between post-traumatic stress symptoms, stimulant use, and treatment outcomes: a secondary analysis of NIDA's Women and Trauma study. Am J Addict. 2014 Jan-Feb;23(1):90-5. doi: 10.1111/j.1521-0391.2013.12068.x. Epub 2013 Jun 26.; Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L. Synergy between seeking safety and twelve-step affiliation on substance use outcomes for women. J Subst Abuse Treat. 2013 Aug;45(2):179-89. doi: 10.1016/j.jsat.2013.01.015. Epub 2013 Apr 1.; Hien DA, Morgan-Lopez AA, Campbell AN, Saavedra LM, Wu E, Cohen L, Ruglass L, Nunes EV. Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more. J Consult Clin Psychol. 2012 Feb;80(1):29-42. doi: 10.1037/a0026361. Epub 2011 Dec 19.; Hien DA, Jiang H, Campbell AN, Hu MC, Miele GM, Cohen LR, Brigham GS, Capstick C, Kulaga A, Robinson J, Suarez-Morales L, Nunes EV. Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network. Am J Psychiatry. 2010 Jan;167(1):95-101. doi: 10.1176/appi.ajp.2009.09091261. Epub 2009 Nov 16.; Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell AN, Cohen LR, Miele GM, Killeen T, Brigham GS, Zhang Y, Hansen C, Hodgkins C, Hatch-Maillette M, Brown C, Kulaga A, Kristman-Valente A, Chu M, Sage R, Robinson JA, Liu D, Nunes EV. Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. J Consult Clin Psychol. 2009 Aug;77(4):607-19. doi: 10.1037/a0016227.; Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, Hatch-Maillette M, Miele GM, Cohen LR, Gan W, Resko SM, DiBono M, Wells EA, Nunes EV. The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study. AIDS Behav. 2010 Apr;14(2):421-30. doi: 10.1007/s10461-009-9573-7. Epub 2009 May 19.
* 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; (submitted: June 23, 2005)	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).
Sex/Gender	Sexes Eligible for Study: Female
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	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