Kranzler 2008.

Trial name or title	Topiramate treatment of problem drinkers
Methods	Randomised placebo‐controlled double‐blind trial
Participants	160 participants Inclusion criteria: both genders; age 18 to 65 years; average weekly ethanol consumption of >= 24 standard drinks for men or >= 18 standard drinks for women; able to read English at the eighth grade or higher level with no evidence of significant cognitive impairment; willing to nominate an individual who will know the participant's whereabouts to facilitate follow‐up during the study; if a woman of child‐bearing potential, must be non‐lactating, practicing a reliable method of birth control and having a negative serum pregnancy test; if applicable, individuals treated with a single antidepressant that has been stable in dosage for a minimum of four weeks; willing to provide signed informed consent to participate in the study Exclusion criteria: current, clinically significant physical disease or abnormality, including direct bilirubin elevations > 110% or transaminase elevations > 300% normal; history of nephrolithiasis, glaucoma, serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder or substantial suicide or violence risk); current DSM‐IV diagnosis of drug dependence (other than nicotine dependence); current DSM‐IV diagnosis of alcohol dependence that is clinically moderate or severe; history of hypersensitivity to topiramate; currently taking any tricyclic antidepressant
Interventions	(1) Topiramate; (2) placebo Dose: topiramate up to 200 mg/d Duration: 12 weeks. Country of origin: USA
Outcomes	Primary outcomes: drinking days and heavy drinking days Secondary outcomes: mean daily alcohol consumption; change in gamma‐glutamyl transferase (GGT) or CDT levels; severity of alcohol‐related problems
Starting date	February 2008
Contact information	Timothy S Pond, BA, 215‐222‐3200, ext 241, pond_t@mail.trc.upenn.edu, University of Pennsylvania, Philadelphia, Pennsylvania, United States 19104
Notes