Topiramate for Alcohol Use in Posttraumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT01408641|
Recruitment Status : Terminated (Principal Investigator was deployed overseas)
First Posted : August 3, 2011
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Alcoholism Alcohol Abuse Alcohol Use Disorder PTSD Posttraumatic Stress Disorder||Drug: Topiramate Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2013|
Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
Other Name: Topamax
Placebo Comparator: Placebo (Sugar Pill)
Placebo arm will receive matching capsules without topiramate.
Placebo capsules without topiramate
- Percentage of Heavy Drinking Days [ Time Frame: 14 weeks ]The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.
- Amount of PTSD Symptoms [ Time Frame: 14 weeks ]The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
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): NCT01408641
|United States, Maryland|
|Baltimore VA, VA Maryland Health Care System|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Bernard A Fischer, M.D.||Department of Veterans Affairs, University of Maryland School of Medicine|