Topiramate Treatment of Alcohol Use Disorders in Veterans With PTSD: A Pilot Controlled Trial of Augmentation Therapy
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: PTSD; Alcohol Abuse; Alcoholism
Intervention: Topiramate (Drug); Placebo administration (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of California, San Francisco
Official(s) and/or principal investigator(s):
Steven L. Batki, MD, Principal Investigator, Affiliation: University of California, San Francisco; Department of Veteran's Affairs
Brooke Lasher, BA, Phone: 415-221-4810, Ext: 4954, Email: email@example.com
The proposed project aims to:
1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing
alcohol use in veterans with PTSD and alcohol dependence;
2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients;
3. Assess the feasibility of recruitment and retention for topiramate treatment in this
comorbid population; and 4) to inform the design of a planned subsequent larger
controlled trial of topiramate.
PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling
will be associated with a significant increase in percent days abstinent from baseline to
end of treatment.
SECONDARY HYPOTHESIS: There will be a significantly greater percent of days abstinent from
alcohol use in the topiramate treatment group compared to the placebo group.
Official title: Topiramate Treatment of Alcohol Use Disorders in Veterans With PTSD: A Pilot Controlled Trial of Augmentation Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in percent days abstinent
The difference in percent days abstinent from alcohol between the topiramate and placebo arms of the study.
PTSD symptom severity in veterans with chronic PTSD and alcohol abuse/dependence
The goal of the proposed project is to improve the treatment of veterans with co-occurring
PTSD and alcohol dependence. Exposure to the stresses of combat is known to be associated
with risk for both PTSD and alcohol and other substance use. PTSD and alcohol use disorders
occur frequently among returning OEF/OIF veterans. Alcohol and substance use are risk
factors for the development of PTSD, moderators of PTSD symptom severity, and potential
consequences of PTSD. Alcohol is by far the most common substance of abuse in patients with
PTSD, and its use may represent an attempt by PTSD patients to "self-medicate" symptoms such
as hyperarousal. However, to date there has been little research to develop
pharmacotherapies that would, ideally, reduce both alcohol use and PTSD symptoms.
Topiramate is one of the few medications for alcohol dependence that has also been tested as
a potential medication to treat PTSD. Topiramate's efficacy in alcohol dependence has been
shown in two recent large controlled trials. Several open trials have suggested that
topiramate may be effective in reducing PTSD symptoms while the results of two small
controlled trials have been mixed.
A clinical trial of topiramate is therefore indicated in order to achieve the following
The primary aim is to obtain a preliminary assessment of the efficacy of topiramate in
increasing the percent of days abstinent from alcohol use from baseline to the end of
treatment in veterans with PTSD and alcohol abuse/dependence who are drinking heavily.
The secondary aim is to obtain a preliminary assessment of the efficacy of topiramate in
increasing the percent of days abstinent from alcohol as compared to placebo.
Additional aims include the following:
- To obtain a preliminary assessment of the efficacy of topiramate in reducing other
measures of alcohol use such as percent heavy drinking days, number of drinks per week,
number of drinks per drinking day, and alcohol craving.
- To obtain a preliminary assessment of the efficacy of topiramate in reducing PTSD
symptom severity in veterans with chronic PTSD and alcohol abuse/dependence.
- Informing the design of a planned subsequent larger controlled trial of topiramate in
veterans with chronic PTSD and alcohol abuse/dependence
- To obtain an estimate of topiramate vs. placebo effect size for future studies. B. To
obtain a preliminary assessment of the effects of topiramate treatment on measures of
risk-taking behavior in veterans with chronic PTSD and alcohol abuse/dependence.
To achieve these aims, we will conduct a prospective, parallel groups, randomized,
double-blind, placebo-controlled flexible-dose pilot clinical trial of topiramate in
veterans with PTSD and alcohol abuse/dependence who are already receiving standard treatment
for PTSD but still drink heavily. The primary treatment outcome will be percent days
abstinent from alcohol; secondary outcomes will include other alcohol use measures, PTSD
symptom severity, adverse effects, recruitment and retention rates.
Minimum age: 18 Years.
Maximum age: 59 Years.
- Male and female outpatient veterans.
- Current DSM-IV diagnosis of PTSD.
- Current (past month) DSM-IV diagnosis of an Alcohol Use Disorder.
- Must meet criteria for "heavy" or "at-risk" drinking by NIAAA thresholds.
- Receiving treatment for PTSD.
- Must express desire to reduce alcohol consumption.
- Female subjects must have negative urine pregnancy test and must be either
postmenopausal for at least one year, or practicing an effective method of birth
- Must have a BAC of less than 0. 02% when signing the informed consent.
- Psychotic disorders, bipolar disorder, dementia, or other psychiatric disorders
judged to be unstable.
- 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 BUN or creatinine or an
estimated creatinine clearance of < 60 mL/min; AST (SGOT) and/or ALT (SGPT) >3 times
the upper limit of the normal range and/or an increased serum bilirubin >2 times the
upper limit of normal; seizure disorders.
- Subjects with glaucoma.
- Subjects with a history of kidney stones.
- Subjects with a history of renal disease.
- Concurrent participation in another treatment study.
- Female patients who are pregnant or lactating.
- Current topiramate use or use within the past 4 weeks.
- Current medications for alcohol dependence or use within the past 4 weeks.
- 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);
- Subjects who are legally mandated to participate in an alcohol treatment program.
- Subjects who have had a suicide attempt or suicidal ideation in the 6 months prior to
- 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
- Subjects with seizure disorders that require anticonvulsant medications
- Subjects currently being treated with another anticonvulsant.
- 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
Locations and Contacts
Brooke Lasher, BA, Phone: 415-221-4810, Ext: 4954, Email: firstname.lastname@example.org
San Francisco VA Medical Center, San Francisco, California 94121, United States
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Starting date: April 2010
Last updated: March 31, 2010