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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Ismene Petrakis, M.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Elizabeth Ralevski, Ph.D., Phone: (203)932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in Timeline Follow-Back (TLFB)assessment

Change in Clinicians Administered PTSD Scale (CAPS)

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Elizabeth Ralevski, Ph.D., Phone: (203)932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu

VA Connecticut Healthcare System, West Haven, Connecticut 06516, United States; Recruiting
Elizabeth Ralevski, Ph.D., Phone: 203-932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu
Additional Information

Starting date: June 2013
Last updated: April 1, 2014

Page last updated: August 23, 2015

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