Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence
Condition: PTSD
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Pharmacotherapy has demonstrated efficacy in a number of controlled trials in the treatment
      of PTSD. The selective serotonin reuptake inhibitors have proven particularly useful in
      treating this disorder. Currently there are two selective serotonin reuptake inhibitors
      (Zoloft® and Paxil®), that have been FDA approved for treating PTSD. Coincidentally, this
      same class of medications has also been shown to have efficacy in some trials in decreasing
      alcohol consumption in heavy drinkers. The goal of the proposed study is to preliminarily
      investigate the efficacy of Paxil® (paroxetine), in decreasing symptoms of PTSD as well as
      decreasing substance use, in individuals with concurrent substance dependence and PTSD. The
      type of paroxetine used in this trial will be Paxil CR®, which is a sustained release
      formulation of paroxetine, which has fewer side effects and greater tolerability. This is a
      particularly important issue in substance using populations because medication compliance is
      generally poor.

      Two specific hypotheses will be tested. 1) Individuals who receive Paxil CR® will have a
      greater improvement in their PTSD symptoms (based on CAPS-2 and CGI) than those who receive
      placebo. 2) Individuals who receive Paxil CR® will have greater improvement in their
      substance use outcomes (based on UDS and TLFB) than will those who receive placebo.
    

Detailed description: 
      Participants who meet all inclusion and no exclusion criteria will be randomized with a 1:1
      ratio to receive either Paxil CR or placebo for 12 weeks. Medication will be initiated at
      12.5mg/day and will be increased weekly as tolerated to a maximum dose of 50mg/day.
      Participants will be seen weekly and will be assessed for side effects, substance use since
      last visit, urine drug screen, breathalyzer readings, vital signs and symptoms of PTSD
      (TOP-8)at each visit. The Davidson Trauma Scale will be completed every two weeks, and the
      CAPS-2 and MADRS will be completed monthly. Those who complete the first 12 weeks of
      double-blind study medication will be eligible to receive open label medication for an
      additional 12 weeks. Medication will be initiated at 12.5mg and increased every 3 days as
      tolerated to the terminal dose in the double-blind phase, then adjusted as needed.
      Participants will come in for assessments every two weeks of the open-label phase. Blood will
      be drawn for blood chemistries and hematology at screening and weeks 12 and 24. Urine
      pregnancy tests will be performed for women of childbearing potential at baseline and again
      at weeks 4, 12 and 24.
    

Intervention name(s): Paroxetine CR
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Substance Abuse; Trauma; Dependence