NCT01847469

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BEHAVIORAL	Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
DRUG	Zonisamide
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2013-05-06
• Last updated: 2020-03-16
• Results posted: 2020-03-16

Locations

1 site across 1 country: United States