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Combined Treatment for Alcohol-Dependent Women With PTSD - NCT00262223-10031B(Clinical Trial 133585)



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City:  New York
State:  
NY
Zip Code: 10031
Conditions: Stress Disorders, Post-Traumatic - Alcohol Abuse - Substance-Related Disorders
Purpose: This treatment intervention trial is designed for women with either alcohol misuse (e.g. alcohol abuse or alcohol dependence) or alcohol use disorders (alcohol abuse or dependence) and comorbid PTSD. Participants will be randomly assigned to one of two treatments (a cognitive behavioral treatment intervention called "Seeking Safety" + Medication ("Zoloft") or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-treatment.
Study summary: The impetus for the current study is to contribute to the development of effective treatments targeted for women with either alcohol misuse (e.g., hazardous or binge drinking) or alcohol use disorders (e.g. alcohol abuse or alcohol dependence) and comorbid PTSD. Research findings have shown that these women have poorer treatment outcomes and show more severe symptoms than treatment seeking alcohol-misusing or 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 use 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 these interventions over either treatment alone. We are comparing "Seeking Safety" alone to "Seeking Safety" in combination with the antidepressant medication sertraline ("Zoloft") in terms of their effectiveness in reducing alcohol use, psychiatric symptoms, and in increasing treatment participation. Participants will be randomly assigned to one of two treatments (Seeking Safety + Med or Seeking Safety + placebo) and will be evaluated at baseline, at completion of the treatment (12 sessions over 12 weeks), and again at 6 months and 12 months post-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.
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 misuse, abuse or 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 or subthreshold 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.
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Data Source: ClinicalTrials.gov
Date Processed: May 10, 2010
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