DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Alcoholism; Alcohol Abuse; Alcohol Use Disorder; PTSD; Posttraumatic Stress Disorder

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Bernard A Fischer, M.D., Principal Investigator, Affiliation: Department of Veterans Affairs, University of Maryland School of Medicine

Overall contact:
Jennifer Duncan, Phone: (410)637-1432, Email: Jennifer.Duncan5@va.gov


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.

Clinical Details

Official title: A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With 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

Primary outcome: Number of days of Heavy Drinking

Secondary outcome:

Number of Days Abstinent

Amount of PTSD Symptoms

Number of Memory/Cognitive Complaints


Minimum age: 21 Years. Maximum age: 64 Years. Gender(s): Male.


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,


- 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)

Locations and Contacts

Jennifer Duncan, Phone: (410)637-1432, Email: Jennifer.Duncan5@va.gov

Baltimore VA, VA Maryland Health Care System, Baltimore, Maryland 21201, United States; Recruiting
Bernard A Fischer, M.D., Principal Investigator
Additional Information

Starting date: September 2012
Last updated: September 10, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017