Status:
COMPLETED
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Lead Sponsor:
Yale University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Alcohol Dependence
Post-Traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01847469
Start Date
June 1 2013
End Date
January 1 2019
Last Update
March 16 2020
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516