Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Condition: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Enhanced-Cognitive Processing Therapy-C (E-CPT-C); Zonisamide; Placebo
Intervention MeSH terms: Zonisamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD); Zonisamide; Cognitive Processing Therapy (CPT)

Summary:

      This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress
      disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive
      either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization
      will be done using 3:1 ratio and will be performed by our research pharmacy using a random
      assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.
      Medication will be titrated over a 6 week titration phase followed by a 6 week treatment
      phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will
      be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.
      Veterans will be recruited primarily through advertisement, but also through the clinical
      facilities at the VA and from other collaborators.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current alcohol dependence, as determined by a structured clinical interview
             (Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID)

          -  Current PTSD as determined by a structured clinical interview (SCID)

          -  Veterans with current alcohol dependence, with at least one recent episode of heavy
             drinking over the past 14 days.

          -  Medically and neurologically healthy on the basis of history, physical examination,
             EKG, screening laboratories

          -  For women, negative pregnancy test and use of acceptable method of contraception

        Exclusion Criteria:

          -  Females who are pregnant or lactating.

          -  Veterans with a current unstable medical condition such as neurological,
             cardiovascular, endocrine, renal, liver, or thyroid pathology, which in the opinion of
             the physician would preclude the subject from fully cooperating or be of potential
             harm during the course of the study

          -  Veterans who meet current SCID criteria for a major Axis I diagnosis (Bipolar
             Disorders, Schizophrenia and Schizophrenia-type Disorders).

          -  History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV
             criteria in the last 90 days.

          -  Veterans taking mood stabilizers and antipsychotic medications for specific
             psychiatric disorders.

          -  Veterans with a history of allergy to zonisamide.

          -  Veterans already receiving CPT.