MedTrace Logo

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

NCT01847469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-03-16

Study results available
· View outcomes & findings →

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.

Conditions

  • Alcohol Dependence
  • Post-Traumatic Stress Disorder (PTSD)

Interventions

BEHAVIORAL

Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

DRUG

Zonisamide

DRUG

Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Yale University

    lead OTHER

Principal Investigators

  • Ismene Petrakis, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2019-01-01
Completion
2019-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847469 on ClinicalTrials.gov