Status:
TERMINATED
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Alcohol Dependence
Alcoholism
Eligibility:
MALE
21-64 years
Phase:
NA
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01408641
Start Date
September 1 2012
End Date
August 1 2013
Last Update
March 3 2022
Active Locations (1)
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1
Baltimore VA, VA Maryland Health Care System
Baltimore, Maryland, United States, 21201