Combined Treatment for Alcohol-Dependent Individuals With PTSD
Condition: Stress Disorders, Post-Traumatic; Alcohol Abuse; Substance-Related Disorders
MeSH terms: Alcoholism; Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This treatment intervention trial is designed for men and women with either alcohol misuse
      (e.g. hazardous or binge drinking) 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.
    

Detailed description: 
      The impetus for the current study is to contribute to the development of effective treatments
      targeted for men and 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 individuals 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 individuals 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 and PTSD symptoms. 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;
      impact of combined treatment on treatment participation and global psychiatric symptoms;
      differences in the time course and order of changes in alcohol and drug use and PTSD symptoms
      by condition.
    

Intervention name(s): Seeking Safety; Sertraline; Pill placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders; An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Co-morbid alcohol dependence and PTSD; Alcohol and other drug use disorders; Treatment outcome