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

Description

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.

Study Start Date

June 2013

Estimated Completion Date

December 2015

Interventions

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

Specialties

  • Psychiatry : Anxiety,Neuro/Psych Pharmacol,Substance Abuse

MeSH Terms

  • Alcoholism
  • Enhanced-Cognitive Processing Therapy-C
  • Post-Traumatic Stress Disorders
  • Zonisamide

Study ID

Yale University -- IP0039

Status

Unknown

Trial ID

NCT01847469

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

30

Sponsor

Yale University

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.

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
VA Connecticut Healthcare System - West Haven, Connecticut 15.6 miles Elizabeth Ralevski PhD 203-932-5711 elizabeth.ralevski@yale.edu

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