Anthenelli 2008.

Trial name or title	Topiramate to aid smoking cessation in recovering alcohol‐dependent men
Methods	Randomised placebo‐controlled double‐blind trial
Participants	180 participants Inclusion criteria: 18 to 65 years of age; male outpatients with a diagnosis of DSM‐IV‐TR nicotine dependence and alcohol dependence in early full remission; current tobacco smokers; motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs Exclusion criteria: any clinically significant laboratory evidence of haematological, hepatic, cardiovascular, renal, pulmonary or thyroid disease; current significant neurological, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious or endocrine disease; a history of known hypersensitivity to topiramate; current suicidal or homicidal risk; any investigational drug taken within 30 days of baseline; current seizure disorder or history of severe alcohol withdrawal
Interventions	(1) Topiramate, 90 participants; (2) placebo, 90 participants Dose: topiramate 200 mg/d Duration: 12 weeks. Country of origin: USA
Outcomes	Primary outcomes: Four‐week continuous abstinence from smoking Secondary outcomes: percentage relapsing to any drinking
Starting date	January 2009
Contact information	Stephanie Nolting, MEd, BA, +151 386 13100 ext 5507, stephanie.nolting@va.gov; Robert Anthenelli, MD, +151 386 13100, ext 4914, robert.anthenelli@va.gov, VA Medical Center, Cincinnati, Ohio, United States 45220
Notes