Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
Condition: PTSD; Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to conduct a clinical trial to evaluate sertraline treatment
      efficacy in a large sample of military veterans with a dual diagnosis of PTSD and Alcohol Use
      Disorder who are receiving Cognitive and Behavioral Therapy as part of the VA-system's new
      dual diagnosis program. The study is designed as an efficacy trial of sertraline used as an
      adjunct to Cognitive Behavioral Therapy (CBT) in the treatment of PTSD/Alcohol dual
      diagnosis. There are two outcomes of interest, namely PTSD symptom improvement and also
      decreased alcohol consumption. The investigators are interested to know whether or not
      sertraline is superior to placebo in improving the symptoms of either one or both of these
      two disorders. Even though sertraline is a treatment of choice for PTSD, the investigators
      expect that the comorbid condition of alcohol dependence will complicate the treatment of
      PTSD and that the clustered subgroups will show differential treatment response with
      sertraline. The primary objective of the present study is to identify subgroups of alcohol
      dependent persons with PTSD who will either benefit or not benefit from treatment with
      SSRI's. The proposed study will enroll veterans with PTSD and dually-diagnosed alcohol
      dependence in a 12-week treatment providing sertraline vs. placebo medication as an adjunct
      to manualized CBT and will specifically test the hypothesis that subtypes of alcohol
      dependence can be used to predict which patients respond well and which subgroup responds
      poorly to SSRI treatment.
    

Detailed description: 
      Experimental Design. The study design is a parallel group, double-blind, placebo-controlled,
      stratified, randomized medication treatment trial of male and female veterans who experienced
      "in-theater" trauma and have both a PTSD and Alcohol Use dual diagnosis. All subjects will
      receive 12 weeks of manualized cognitive & behavioral therapy as a standard of care.
      Additionally, subjects will be randomized 1:1 to receive double-blind treatment with
      Sertraline vs. Placebo as an adjunctive treatment. The manualized therapy provides standard
      cognitive-behavioral therapy (CBT) addressing alcohol use and prolonged exposure (PE)
      behavioral therapy targeting PTSD. Sertraline is a common treatment for PTSD and psychiatric
      disturbance but is hypothesized to have differential efficacy in different subtypes of
      alcohol drinking patients. A stratified randomization scheme will balance placebo and
      sertraline assignment to two groups, and a post-hoc clustering approach will be used to
      determine which subgroups of dual diagnosis patients may benefit from sertraline vs. placebo
      treatment.

      Veterans with PTSD who regularly drink more than 5 standard drinks of alcohol in a day (note
      one 12oz beer = one standard drink) may be eligible for the study if they meet criteria.
    

Intervention name(s): Sertraline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.; A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm.
Other intervention name(s): Zoloft; Placebo Control
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Alcohol; Dual Diagnosis; Sertraline; SSRI