A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
Condition: Alcohol Dependence; Posttraumatic Stress Disorder (PTSD)
MeSH terms: Alcoholism; Stress Disorders, Post-Traumatic
Intervention: Topiramate; placebo; Medical Management
Intervention description: Experimental study drug; Placebo comparator; Brief alcohol counseling
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pharmacotherapy; alcohol dependence; Veterans

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.
    

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.