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Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI (VAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01750268
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of the proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury (TBI) Hazardous and Harmful Alcohol Use Behavioral: Medical Management Counseling Drug: Topiramate Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2012
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Topiramate
Topiramate capsules daily - up to 300 mg
Behavioral: Medical Management Counseling
Brief alcohol and medication counseling
Drug: Topiramate
Experimental medication
Other Name: Topamax
Placebo Comparator: Placebo
Placebo capsules daily - up 300 mg
Behavioral: Medical Management Counseling
Brief alcohol and medication counseling
Drug: Placebo
Placebo comparator

Outcome Measures

Primary Outcome Measures :
  1. Change in the number of drinking days as assessed by the Timeline Followback (TLFB) [ Time Frame: Basline to Week 12 ]
    Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.

Secondary Outcome Measures :
  1. Change in TBI symptoms as assessed by the Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Basline to Week 12 ]
    Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms.

Other Outcome Measures:
  1. Change in alcohol use as assessed by the Timeline Followback (TLFB) [ Time Frame: Baseline to Week 12 ]
    Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Male and female veterans.
  2. Ages 18 to 65 (inclusive).
  3. TBI: a history of mild traumatic brain injury, as defined by American Congress of Rehabilitation Medicine (ACRM) and VA, in the chronic, stable phase of recovery (>6 months from injury). The ACRM defines mild TBI as a traumatically-induced physiological disruption of brain function as demonstrated by at least one of the following:

3.a. loss of consciousness of up to 30 minutes;

3.b. any loss of memory for events immediately before or after the event;

3.c. any alteration in mental state at the time of the event, for example feeling dazed, disoriented, or confused; and

3.d. a focal neurological deficit or deficits that may or may not have been transient, for example loss of coordination, speech difficulties, or double vision. ACRM's definition further specifies that a person may be designated as having a mild TBI only if the severity of the injury does not include a loss of consciousness that lasted longer than 30 minutes, and post-traumatic amnesia lasting longer than 24 hours.


  1. This is the most common description of patients currently served by our VA facilities.
  2. Studies at this stable phase will facilitate detection of otherwise subtle changes as findings are less likely to be confounded by 'spontaneous' recovery.

4. Current (past month) hazardous alcohol use or harmful alcohol use.

4.a. Hazardous use is drinking that must meet criteria for "at-risk" or "heavy" drinking by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria: Subjects must report current (past 30 day) "at-risk" or "heavy" drinking on an average weekly basis, consisting of an average of 15 or more standard drinks per week for men and 8 or more standard drinks per week for women during the 30 days prior to Screening Visit 1 as measured by the Alcohol Timeline Followback (TLFB) method.

4.b. Harmful use is drinking behavior that meets Diagnostic and Statistical Manual (DSM)-IV diagnostic criteria for an Alcohol Use Disorder (Alcohol Dependence or Alcohol Abuse).

5. Subjects must express a desire to reduce or stop alcohol use.

6. Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least 1 year or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or absent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence).

7. Subjects must have a Breath Alcohol Concentration (BAC) of less than 0.02% when signing the informed consent form.

Exclusion Criteria

  1. Psychotic disorders, bipolar disorders, 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 a serum bilirubin > 2 times the upper limit of normal.
  3. History of glaucoma.
  4. History of kidney stones.
  5. Concurrent participation in another alcohol treatment study or any study involving medications.
  6. Female patients who are pregnant or lactating.
  7. Topiramate use in the past week prior to study entry.
  8. Use of medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) within 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, with intent, in the 30 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.
  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750268

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
United States Department of Defense
Northern California Institute of Research and Education
San Francisco Veterans Affairs Medical Center
Principal Investigator: Steven L. Batki, MD University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01750268     History of Changes
Other Study ID Numbers: W81XWH-11-2-0145
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by University of California, San Francisco:
hazardous and harmful alcohol use
co-occurring disorders

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Alcohol Drinking
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Drinking Behavior
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents