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

NCT01847469 | Completed Phase 2 Results DMC

• 2 other identifiers: 121101106301641
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD); Zonisamide; Cognitive Processing Therapy (CPT)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Zonisamide

EXPERIMENTAL

Participants in this arm will receive zonisamide for 12 weeks.

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

Placebo

PLACEBO COMPARATOR

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

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

Interventions

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

Placebo; Zonisamide

Zonisamide DRUG

Also known as: Zonegran

Zonisamide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• United States Department of Defense: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ismene Petrakis
• Organization: Yale University School of Medicine, VA Connecticut Healthcare System

ismene.petrakis@yale.edu

(203) 932-5711

Study Officials

• Ismene Petrakis, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: May 6, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Locations

US (1)