Clinical trial NCT01408641: Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Official title: A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Dependence
Alcoholism
Alcohol Abuse
Alcohol Use Disorder
PTSD
Posttraumatic Stress Disorder
Keywords: topiramate
PTSD
drinking
alcohol
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2011-08-03
Enrollment: 4
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male
* Ages 21-64
* Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
* Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
* A desire to reduce drinking behavior
* Any Race/Ethnicity

Exclusion Criteria:

* Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
* Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
* Change in benzodiazepine dose within the previous 3 months
* Change in other (non-benzodiazepine) medication dose within the last 4 weeks
* Seizure disorder documented in the medical record
* Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
* Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
* A history of kidney stones
* A history of glaucoma
* ALT or AST liver enzymes elevated more than twice the upper limit of normal
* More than 4 unsuccessful attempts at inpatient alcohol treatment
* Medically unstable (including significant hypertension despite adequate treatment)
* A history of delirium tremens ("DTs") or alcohol withdrawal seizure
* Compulsory treatment to avoid legal consequences (e.g. imprisonment)
* Currently in a setting without access to alcohol (e.g. locked inpatient unit)

Primary outcomes:
measure: Percentage of Heavy Drinking Days
timeFrame: 14 weeks
Secondary outcomes:
measure: Amount of PTSD Symptoms
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA, VA Maryland Health Care System
state: Maryland
Study officials:
affiliation: Department of Veterans Affairs, University of Maryland School of Medicine
name: Bernard A Fischer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: