INTRODUCTION: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 received100 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.
RCT Entities:
INTRODUCTION: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: Louisa G Sylvia; Alexandra K Gold; Jonathan P Stange; Andrew D Peckham; Thilo Deckersbach; Joseph R Calabrese; Roger D Weiss; Roy H Perlis; Andrew A Nierenberg; Michael J Ostacher Journal: Am J Addict Date: 2016-02-19
Authors: Giovanni Martinotti; Rita Santacroce; Mauro Pettorruso; Chiara Montemitro; Maria Chiara Spano; Marco Lorusso; Massimo di Giannantonio; Arturo G Lerner Journal: Brain Sci Date: 2018-03-16
Authors: Kirsten C Morley; Henry R Kranzler; Natasha Luquin; Andrew Baillie; Marian Shanahan; Ronald Trent; Maree Teesson; Paul S Haber Journal: Trials Date: 2018-08-16 Impact factor: 2.279