PROTOCOL NIDA-CTN-0015


Women's Treatment for Trauma and Substance Use Disorders

Denise Hien, PhD
Lead Investigator
Women's Health Project
Saint Luke's Roosevelt Hospital Center
dah26@columbia.edu

Post-Traumatic Stress Disorder (PTSD) is common among people with substance use disorders, and patients suffering from both of these conditions have a more difficult time meeting their treatment goals.  Estimates suggest that as many as 80% of women seeking treatment for drug abuse report lifetime histories of sexual and/or physical assault.  These facts highlight the importance of finding effective treatments for this high-risk population.  Early studies showed that Seeking Safety, a treatment designed specifically for patients with PTSD and substance use disorders, held great potential for this population. This study compared the effectiveness of Seeking Safety added to substance abuse treatment-as-usual (TAU) with Women’s Health Education added to TAU.  The researchers looked at the effect of these treatment options on both substance use and the severity of PTSD symptoms.
CTN-0015 Study Protocol

PRIMARY FINDINGS

Analyses showed large, clinically significant reductions in PTSD symptoms over the course of treatment and follow-up, but no reliable difference between the study groups.  Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline.  Seeking Safety therapy was not associated with increases in substance use, adverse events, or dropout from treatment or study participation.  The results reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions.

Primary Outcomes Article: Hien D, et al. Multisite Randomized Trial of Behavioral Interventions for Women with Co-Occurring PTSD and Substance Use Disorders. Journal of Consulting and Clinical Psychology 2009;77(4):607-619. [get article]

RELATED STUDIES
RELATED RESOURCES

Publications about CTN-0015

Study data from NIDA Data Share

Study Manual: Miller S, et al. Women's Health Education. In Peer Activism for Female Partners of Injection Drug Users. Unpublished manual, Columbia University, 1998

Study Manual: Najavits LM. Seeking Safety: A Treatment Manual for PTSD and Substance Abuse. New York: Guilford Press, 2002

ClinicalTrials.gov (NCT00078156)

NIDA protocol page

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 2/2011 -- http://ctndisseminationlibrary.org/protocols/ctn0015.htm
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