Clinical trial NCT01847469: Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Official title: Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Dependence
Post-Traumatic Stress Disorder (PTSD)
Keywords: Alcohol Dependence
Post-Traumatic Stress Disorder (PTSD)
Zonisamide
Cognitive Processing Therapy (CPT)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

Primary outcomes:
measure: Number of Drinking Days
timeFrame: 12 weeks
measure: Number of Heavy Drinking Days
timeFrame: 12 weeks
measure: Clinician-Administered PTSD Scale (CAPS) Total Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Ismene Petrakis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: