Fischer 2011.

Trial name or title	A 14‐week randomised, placebo‐controlled study of topiramate for alcohol use disorders in veterans with post‐traumatic stress disorder
Methods	Randomised placebo‐controlled double‐blind trial
Participants	30 participants Inclusion criteria: male; ages 21 to 64 years; diagnosis of PTSD with a score of 50 or higher on the Clinician Administered PTSD scale (CAPS); alcohol abuse or dependence diagnosis in the medical record or by consuming more than 35 standard drinks per week over the previous four weeks as measured by the TLFB interview; a desire to reduce drinking behaviour Exclusion criteria: taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide); taking or having recently taken acamprosate, naltrexone, disulfiram, topiramate; change in benzodiazepine or other medication dose within the past four weeks; seizure disorder; head trauma with loss of consciousness or a diagnosis of postconcussive syndrome; suicide attempt or suicidal ideation; history of kidney stones; history of glaucoma; ALT or AST liver enzymes elevated more than twice the upper limit of normal; more than four unsuccessful attempts at inpatient alcohol treatment; medically unstable; a history of delirium tremens or alcohol withdrawal seizure; compulsory treatment to avoid legal consequences; currently in a setting without access to alcohol
Interventions	(1) Topiramate; (2) placebo Dose: topiramate up to 400 mg/d Duration: 14 weeks. Country of origin: USA
Outcomes	Primary outcome: number of days of heavy drinking Secondary outcomes: number of days abstinent; number of PTSD symptoms; number of memory/cognitive complaints
Starting date	August 2011
Contact information	Jennifer Duncan, (410) 605‐7000, ext 4738, Jennifer.Duncan5@va.gov, Department of Veterans Affairs, University of Maryland School of Medicine, Maryland Health Care System, Baltimore, Maryland, United States 21201
Notes