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

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

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 Overview

• Status: Completed
• Conditions: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Drug: Placebo; Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C); Drug: Zonisamide

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zonisamide; Participants in this arm will receive zonisamide for 12 weeks.	Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C); Drug: Zonisamide; Other Names: Zonegran
Placebo Comparator: Placebo; Participants in this arm will receive placebo medication for 12 weeks.	Drug: Placebo; Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Drinking Days	Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.	12 weeks
Number of Heavy Drinking Days	Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women.	12 weeks
Clinician-Administered PTSD Scale (CAPS) Total Score	The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms.	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ismene Petrakis, M.D., Yale University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Alcohol Dependence; Zonisamide; Post-Traumatic Stress Disorder (PTSD); Cognitive Processing Therapy (CPT)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Trauma and Stressor Related Disorders; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Zonisamide
• Other Study ID Numbers: 1211011063; 01641 (Other Identifier: VA IRB)