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

Yale University

Status and phase: Completed; Phase 2

Conditions: Post-Traumatic Stress Disorder (PTSD); Alcohol Dependence

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01847469

1211011063

01641 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

24 participants in 2 patient groups, including a placebo group

Zonisamide

Experimental group

Description:

Participants in this arm will receive zonisamide for 12 weeks.

Treatment:

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

Drug: Zonisamide

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive placebo medication for 12 weeks.

Treatment:

Drug: Placebo

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