Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems
Condition: PTSD; Alcohol Use Disorder
MeSH terms: Alcoholism
Intervention: Sertraline; Placebo
Intervention description: 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.
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PTSD; Alcohol; Dual Diagnosis; Sertraline; SSRI

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21-65 year old Veterans with PTSD who regularly drink more than 5 standard drinks of
             alcohol in a day

          -  who experienced a trauma during deployment and

          -  who regularly drink more than 5 standard drinks alcohol and

          -  are interested in coming in once per week for 12 weeks of dual diagnosis individual
             therapy and

          -  are willing to participate in a placebo-controlled trial which could include receipt
             of sertraline (Zoloft).

        Exclusion Criteria:

          -  if their PTSD Symptoms are adequately controlled by other medication regimens;

          -  they require inpatient alcohol detoxification; or currently receive naltrexone,
             disulfiram, acamprosate, or ondansetron treatment for alcohol dependence; or

          -  currently have an unstable medical illness; or

          -  have a bipolar or psychotic disorder; or

          -  currently are taking and are unwilling to discontinue taking any SSRI, SNRI, MAO
             inhibitor, tricyclic antidepressant, or anticonvulsant.