A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

NCT ID: NCT01749215

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2019-07-31

Brief Summary

The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Detailed Description

This project consists of a controlled clinical trial of topiramate treatment to reduce alcohol use and PTSD symptoms in veterans with these co-occurring disorders.

This is a prospective randomized double-blind controlled parallel groups clinical trial of topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over a 12-week treatment period with a week 16 follow-up. The study population consists of 150 male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol use disorder and PTSD. Subjects meet with research staff weekly to receive study medication, manualized alcohol counseling, and research assessments. The primary treatment outcome is the percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory measures include assessments of impulsivity and decision-making.

Conditions

Alcohol Dependence; Posttraumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topiramate

Topiramate capsules daily - up to 300 mg

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

Experimental study drug

Medical Management

Intervention Type: BEHAVIORAL

Brief alcohol counseling

Placebo

Placebo capsules daily - up to 300 mg

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo comparator

Medical Management

Intervention Type: BEHAVIORAL

Brief alcohol counseling

Interventions

Topiramate

Experimental study drug

Intervention Type: DRUG

placebo

Placebo comparator

Intervention Type: DRUG

Medical Management

Brief alcohol counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Male and female veterans

2. Ages18 to 69 (inclusive)

3. Current DSM-IV diagnosis of PTSD

4. Current (past month) DSM-IV diagnosis of an Alcohol Dependence

5. Level of drinking must meet criteria for "at-risk " or "heavy" drinking by NIAAA threshold (NIAAA 2007): at least 15 standard drinks per week on average over the 4 weeks prior to study entry for men and at least 8 standard drinks per week on average for women.

6. Subjects must express a desire to reduce alcohol consumption with the possible long-term goal of abstinence.

7. Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least one year, or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)

8. Subjects must have a Breath Alcohol Concentration (BAC) of < 0.02% when signing informed consent.

Exclusion Criteria

1. Psychotic disorders, bipolar disorder, dementia, or other psychiatric disorders judged to be unstable.

2. Subjects known to have clinically significant unstable medical conditions, including but not limited to:

• Clinically significant renal disease and/or impaired renal function as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min
• AST and/or ALT >5 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal.
• Seizure disorders

3. History of glaucoma.

4. History of kidney stones.

5. Concurrent participation in another treatment study.

6. Female patients who are pregnant or lactating.

7. Current Topiramate use or use within the past 4 weeks.

8. Current medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) or use in the past week.

9. Needing acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD);

10. Subjects who are legally mandated to participate in an alcohol treatment program.

11. Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in the 90 days prior to enrollment.

12. Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate,

13. Subjects with seizure disorders that require anticonvulsant medications

14. Subjects currently being treated with another anticonvulsant.

15. Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the topiramate package insert.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven L. Batki, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-11-PHTBI-BAPHA

Identifier Type: OTHER

Identifier Source: secondary_id

PT110423

Identifier Type: -

Identifier Source: org_study_id