Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence

Conditions
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Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
* Drug: Zonisamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zonisamide<br>Participants in this arm will receive zonisamide for 12 weeks. | Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)<br> <br> Drug: Zonisamide<br> <br> * Other names: Zonegran;|
| Placebo Comparator: Placebo<br>Participants in this arm will receive placebo medication for 12 weeks. | Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drinking Days | Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used. | 12 weeks | 
| Number of Heavy Drinking Days | Timeline Follow Back (TLFB) will be used to document the number of heavy drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women. | 12 weeks | 
| Clinician-Administered PTSD Scale (CAPS) Total Score | The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates none. The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD), Zonisamide, Cognitive Processing Therapy (CPT)