Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.
Alcohol Use Disorder
Posttraumatic Stress Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder|
- Number of days of Heavy Drinking [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Number of Days Abstinent [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Amount of PTSD Symptoms [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Number of Memory/Cognitive Complaints [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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
|Contact: Jennifer Duncan||(410)637-1432||Jennifer.Duncan5@va.gov|
|United States, Maryland|
|Baltimore VA, VA Maryland Health Care System||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator: Bernard A Fischer, M.D.|
|Principal Investigator:||Bernard A Fischer, M.D.||Department of Veterans Affairs, University of Maryland School of Medicine|