A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD (TAP2)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01749215|
Recruitment Status : Recruiting
First Posted : December 13, 2012
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Posttraumatic Stress Disorder (PTSD)||Drug: Topiramate Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Topiramate capsules daily - up to 300 mg
Placebo Comparator: Placebo
Placebo capsules daily - up to 300 mg
- Change in alcohol use as assessed by the Alcohol Timeline Followback (TLFB) [ Time Frame: Baseline to Week 12 ]Using a calendar, participants provide retrospective estimates of daily drinking over a specified time period.
- Change in PTSD symptom severity as assessed by the PTSD Checklist (PCL) [ Time Frame: Baseline to Week 12 ]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 ]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 ]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 ]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.
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): NCT01749215
|Contact: Steven L. Batki, MD||415/221-4810 ext email@example.com|
|Contact: Brooke A. Lasher, BA||415/221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Principal Investigator: Steven L. Batki, MD|
|Principal Investigator:||Steven L. Batki, MD||University of California, San Francisco|