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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00262223 |
The purpose of this study is to compare four different treatment conditions for women with comorbid alcohol dependence and Posttraumatic Stress Disorder (PTSD). We are comparing two behavioral treatments, Seeking Safety, a treatment that focuses on substance use and trauma-related issues and Twelve-Step Facilitation, a treatment designed to promote the individual's activity in traditional activities of Alcoholic Anonymous, alone and also in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use, psychiatric symptoms, and in increasing treatment participation.
Condition | Intervention | Phase |
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Stress Disorders, Post-Traumatic Alcohol Abuse Substance-Related Disorders |
Drug: Sertraline ("Zoloft") Behavioral: Cognitive-behavioral treatment Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Combined Treatment for Alcohol-Dependent Women With PTSD |
Estimated Enrollment: | 365 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1) Seeking Safety + Sertraline: Active Comparator
Seeking Safety + Sertraline
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Drug: Sertraline ("Zoloft")
Treating over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
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2) Seeking Safety + Placebo: Placebo Comparator
Seeking Safety + Placebo;
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Drug: Placebo
Placebo
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3) 12-Step + Sertraline: Active Comparator
Twelve-Step Facilitation +Sertraline
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Drug: Sertraline ("Zoloft")
Treating over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
Behavioral: Cognitive-behavioral treatment
Twelve-Step Facilitation over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
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4) 12-Step + Placebo: Placebo Comparator
Twelve-Step Facilitation + Placebo
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Behavioral: Cognitive-behavioral treatment
Twelve-Step Facilitation over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
Drug: Placebo
Placebo
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The impetus for the current study is to contribute to the development of effective treatments targeted for women with comorbid alcohol dependence and PTSD. Research findings have shown that these women have poorer treatments outcomes and show more severe symptoms than treatment seeking alcohol-dependent participants without PTSD. The aim of this study is to replicate and expand on
Our randomized, 4-armed clinical trial will assess the relative efficacy of 4 active treatments: Seeking Safety + Sertraline; Seeking Safety + Placebo; Twelve-Step Facilitation +Sertraline; Twelve-Step Facilitation + Placebo in treating urban women with alcohol dependence and comorbid PTSD over a three month period with repeated measures at baseline, completion of treatment (3 months), 6-month and 12-month post-treatment follow-ups.
The main outcomes to be examined in the present study are efficacy in: 1a) reducing alcohol drinks/drinking days and increasing abstinence; 1b) reducing PTSD symptom severity; 1c) reducing global psychiatric symptom severity; 1d) improving retention rates in alcohol treatment. Secondary aims of the study include exploring potential differences between alcoholic subtypes on treatment outcomes, and the trends of alcohol and drug use and PTSD symptom changes in each condition to determine any differences in the time course and order of changes.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nathilee A. Caldeira, PhD | 212-650-7821 | nac2116@columbia.edu |
Contact: Denise A. Hien, PhD | 212-650-5666 | Dah26@Columbia.edu |
United States, New York | |
City College, City University of New York | Recruiting |
New York, New York, United States, 10031 | |
Contact: Nathilee A. Caldeira, PhD 212-650-7821 nac2116@columbia.edu | |
Contact: Lisa R. Cohen, Ph.D. lc2130@columbia.edu | |
Principal Investigator: Denise A. Hien, PhD | |
Women's Health Project, St. Luke's Rossevelt Hospital Center | Recruiting |
New York, New York, United States, 10027 | |
Contact: Denise A Hien, Ph.D. 212-750-5666 dah26@columbia.edu | |
Contact: Nathilee A Caldeira, Ph.D. 212-650-7821 nac2116@columbia.edu | |
Principal Investigator: Denise A. Hien, Ph.D. |
Principal Investigator: | Denise A. Hien, PhD | St. Luke's-Roosevelt Hospital Center |
Responsible Party: | New York State Psychiatric Institute ( Denise Hien, Ph.D., Research Scientist and Professor ) |
Study ID Numbers: | NIAAAHIE014341, NIH grant AA014341 |
Study First Received: | December 5, 2005 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00262223 |
Health Authority: | United States: Federal Government |
Co-morbid alcohol dependence and PTSD Trauma Alcohol and other drug use disorders Treatment outcome Cognitive-behavioral treatment (CBT) |
Twelve-Step Facilitation Therapy Combination of anti-depressant medication and behavioral treatment Post-traumatic Stress Disorder (PTSD) Co-morbid Alcohol and other drug use disorders (AOD) |
Anxiety Disorders Mental Disorders Alcoholism Wounds and Injuries Substance-Related Disorders Sertraline |
Disorders of Environmental Origin Stress Disorders, Post-Traumatic Stress Alcohol-Related Disorders Stress Disorders, Traumatic Ethanol |
Pathologic Processes Disease |