A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD (TAP2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of California, San Francisco
Sponsor:
Collaborators:
United States Department of Defense
San Francisco Veterans Affairs Medical Center
Northern California Institute of Research and Education
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01749215
First received: November 9, 2012
Last updated: June 26, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Alcohol Dependence
Posttraumatic Stress Disorder (PTSD)
Drug: Topiramate
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in alcohol use as assessed by the Alcohol Timeline Followback (TLFB) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Using a calendar, participants provide retrospective estimates of daily drinking over a specified time period.


Secondary Outcome Measures:
  • Change in PTSD symptom severity as assessed by the PTSD Checklist (PCL) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The PCL is a 17-item self-report measure reflecting DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely".

  • Change in impulsivity as assessed by Delay Discounting [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The DD task provides a measure of impulsivity by evaluating discount rates for rewards delayed by 10 seconds.

  • Change in risk-taking behavior as assessed by the Balloon Analogue Risk Task (BART) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior.

  • Change in decision-making behavior as assessed by the Iowa Gambling Task (IGT) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The Iowa Gambling Task (IGT) is a computerized assessment that evaluates decision making mediated by the prefrontal cortex by tracking the selection of avantageous or disadvantageous electronic cards from four desks.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topiramate
Topiramate capsules daily - up to 300 mg
Drug: Topiramate
Placebo Comparator: Placebo
Placebo capsules daily - up to 300 mg
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749215

Contacts
Contact: Steven L. Batki, MD 415/221-4810 ext 3671 steven.batki@ucsf.edu
Contact: Brooke A. Lasher, BA 415/221-4810 ext 4954 brooke.lasher@va.gov

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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01749215     History of Changes
Other Study ID Numbers: PT110423  W81XWH-11-PHTBI-BAPHA 
Study First Received: November 9, 2012
Last Updated: June 26, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
pharmacotherapy
alcohol dependence
Veterans

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Alcoholism
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Topiramate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 30, 2016