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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-01-01

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.

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Detailed Description

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Conditions

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Alcohol Dependence Post-Traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zonisamide

Participants in this arm will receive zonisamide for 12 weeks.

Group Type EXPERIMENTAL

Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

Intervention Type BEHAVIORAL

Zonisamide

Intervention Type DRUG

Placebo

Participants in this arm will receive placebo medication for 12 weeks.

Group Type PLACEBO_COMPARATOR

Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

Interventions

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Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

Intervention Type BEHAVIORAL

Zonisamide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zonegran

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No