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
Co-Morbid Alcohol and Other Drug Use Disorders (AOD) Post-Tramautic Stress Disorder (PTSD)	Drug: Sertraline (“Zoloft”)  Behavior: Cognitive-behavioral treatment	Phase II

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcomes: Substance use severity; PTSD symptom severity; Global psychiatric severity; Retention rates in alcohol treatment
Secondary Outcomes: Alcohol subtypes based on pre-morbid risk factors; Trajectory and trends of changes in substance use and PTSD symptoms
Expected Total Enrollment:  365

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

1. pilot studies demonstrating the effectiveness of a manualized cognitive-behavioral treatment specifically designed for women with comorbid substance abuse disorders and PTSD, “Seeking Safety,”
2. preliminary results on the effectiveness of the antidepressant sertraline (“Zoloft”) for a dually diagnosed population and
3. the examination of the effectiveness of a combination of these interventions over either treatment alone.

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   -   65 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

1. Females who are a minimum of 18 years and maximum of 65 years.
2. Participants meet DSM-IV criteria for current alcohol dependence.
3. Participants must have current alcohol use over past 90 days defined by more than or equal to 2 heavy drinking days or more than or equal to 14 drinks over 30 consecutive days or abstinence less than or equal to 21 consecutive days.
4. Participants meet criteria for full PTSD.
5. Participants demonstrate no gross organic mental syndrome.
6. Participants are capable of giving informed consent and capable of complying with study procedures.
7. Participants speak English

Exclusion Criteria:

1. Participants are currently suicidal, or homicidal.
2. Participants who carry a current Axis-I diagnosis other than depressive, anxiety or adjustment disorders. Current diagnosis of Bipolar I and psychotic disorders are exclusionary.
3. Participants who are currently severely depressed.
4. Participants with a history of psychosis or mania.
5. Participants with organic mental syndrome
6. Participants with advanced stage medical disease (e.g., AIDS, TB) as indicated by global physical deterioration and incapacitation.
7. Participants with unstable physical disorders which might make antidepressant treatment hazardous examination such as uncontrolled hypertension, diabetes, heart disease, or hepatitis with transamine levels greater than three times the upper limit of normal.
8. Participants with a known history of seizures (not related to alcohol withdrawal).
9. Participants with moderate to severe alcohol withdrawal that would require pharmacological intervention.
10. Participants currently taking prescribed psychotropic medication.
11. Participants with a known history of an allergic reaction to sertraline.
12. Women who are currently pregnant or are trying to get pregnant or are nursing or are pre-menopausal and sexually active but not using effective birth control.
13. Participants refusing to be audio or videotaped.

Please refer to this study by ClinicalTrials.gov identifier  NCT00262223

Danielle D. Vinocur, PhD      212-523 7698    Dvinocur@chpnet.org
Denise A. Hien, PhD      212-851-2581    Dah26@Columbia.edu

New York
      Women’s Health Project Treatment and Research Center, St.Luke’s Roosevelt Hospital Center, New York,  New York,  10027,  United States

Study chairs or principal investigators

Denise A. Hien, PhD,  Principal Investigator,  St. Luke''''s-Roosevelt Hospital Center   

Study ID Numbers:  NIAAAHIE014341; NIH grant AA014341
Last Updated:  December 8, 2005
Record first received:  December 5, 2005
ClinicalTrials.gov Identifier:  NCT00262223
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10