Who is sponsoring NCT01408641?

NCT01408641 is sponsored by University of Maryland, Baltimore.

What condition does NCT01408641 study?

NCT01408641 studies Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder.

What drugs are being tested in NCT01408641?

Interventions: Topiramate, Placebo.

What is the status of NCT01408641?

NCT01408641 is currently TERMINATED.

Last reviewed 2022-03-01 · How we verify

A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder

NCT01408641 NA TERMINATED Results posted

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.

Details

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	TERMINATED
Enrolment	4
Start date	2012-09
Completion	2013-08

Conditions

Alcohol Dependence
Alcoholism
Alcohol Abuse
Alcohol Use Disorder
PTSD
Posttraumatic Stress Disorder

Interventions

Topiramate
Placebo

Primary outcomes

Percentage of Heavy Drinking Days — 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.

Countries

United States