title: Low-dose topiramate in alcohol dependence: a single-blind, placebo-controlled study.
abstract: BACKGROUND
  Topiramate (TOP) and anticonvulsants in general are considered safe and effective drugs for the treatment of alcohol dependence, even though TOP-induced adverse events are quite common, especially for high initial doses or if titration to 300 mg/d is too rapid. The aim of the present study was to assess the efficacy and tolerability profile of low-dose TOP for relapse prevention.
  
  
  METHODS
  After detoxification, 52 patients were randomized into 2 groups as follows: 26 patients received 100 mg of TOP (oral, twice daily), titrated over 2 weeks, and 26 patients received placebo (PLA). Both groups underwent rehabilitation twice a week.
  
  
  RESULTS
  After 6 weeks of treatment, compared with the PLA group, patients receiving TOP showed the following: (1) fewer drinking days (P < 0.05); (2) less daily alcohol consumption (P < 0.05); (3) more days of treatment (P < 0.05); (4) reduced levels of craving (Obsessive-Compulsive Drinking Scale) and withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised); and (5) improvement of anxiety, depression, and obsessive-compulsive symptom severity (Symptom Check List 90 Revised).
  
  
  CONCLUSIONS
  Despite the small sample size and the short follow-up period, the present PLA-controlled study demonstrated the potential usefulness of TOP, even when administered at a dosage of 100 mg/d, for the treatment of detoxified alcohol-dependent subjects, confirming results from previous studies testing higher doses of TOP.
authors.affiliation: From the *Department of Neuroscience and Imaging, University "G. d'Annunzio," Chieti; †Institute of Psychiatry and Psychology, Catholic University of Sacred Heart, Rome; ‡Casa di Cura, Villa Silvia, Senigallia; and §Department of Developmental Psychology and Education, University of Cassino, Cassino, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinotti
authors.forename: Marco
authors.initials: M
authors.lastname: Di Nicola
authors.forename: Ofelia
authors.initials: O
authors.lastname: De Vita
authors.forename: Daniele Stavros
authors.initials: DS
authors.lastname: Hatzigiakoumis
authors.forename: Riccardo
authors.initials: R
authors.lastname: Guglielmo
authors.forename: Barbara
authors.initials: B
authors.lastname: Santucci
authors.forename: Fererica
authors.initials: F
authors.lastname: Aliotta
authors.forename: Roberto
authors.initials: R
authors.lastname: Romanelli
authors.forename: Valeria
authors.initials: V
authors.lastname: Verrastro
authors.forename: Filippo
authors.initials: F
authors.lastname: Petruccelli
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Giannantonio
authors.forename: Luigi
authors.initials: L
authors.lastname: Janiri
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000175:diagnosis* / Q000188:drug therapy*; D000927:Anticonvulsants / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose