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

Primary Purpose

Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Zonisamide
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD), Zonisamide, Cognitive Processing Therapy (CPT)

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zonisamide

Placebo

Arm Description

Participants in this arm will receive zonisamide for 12 weeks.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2013
Last Updated
March 2, 2020
Sponsor
Yale University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01847469
Brief Title
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Official Title
Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)
Keywords
Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD), Zonisamide, Cognitive Processing Therapy (CPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zonisamide
Arm Type
Experimental
Arm Description
Participants in this arm will receive zonisamide for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive placebo medication for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced-Cognitive Processing Therapy-C (E-CPT-C)
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Other Intervention Name(s)
Zonegran
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Drinking Days
Description
Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.
Time Frame
12 weeks
Title
Number of Heavy Drinking Days
Description
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.
Time Frame
12 weeks
Title
Clinician-Administered PTSD Scale (CAPS) Total Score
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismene Petrakis, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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