Introduction: Effectiveness and tolerability of topiramate at 3 and 6 months was assessed in patients requesting dehabituation programs.
Methods: Observational, prospective, national and multicenter study of 6 months, in patients on treatment with topiramate, who fulfilled criteria for dependence of opiates according to ICD-10 participating in therapeutic programs of dehabituation, without concomitant psychiatric illnesses and any responsible relative. Main measures of effectiveness were retention rates, alcohol consumption and other illicit drugs by urine tests (opiates, cannabis, cocaine) and treatment needs by EuropASI scale. Other parameters were HAM-D, DAS-SV and SF-36.
Results: Patients with consumption by urine tests decreased from 94.1 % (n = 64) at baseline to 39.6 % (n = 19) after 6 months of treatment, as was seen by means of the mean score in EuropASI scale, for all substances except methadone. No consumption was accompanied by a low rate of relapse of 33.3 % at 6 months. Twenty one patients had adverse reactions (28 %). The most frequent adverse reactions were somnolence (n = 9; 12 %), paraesthesia (n = 5; 6.7 %) and depression (n = 4; 5.3 %).
Conclusions: In real clinical practice, topiramate showed a good response with a relevant decrease of percent of patients with abuse or consumption, and a satisfactory tolerability profile for the treatment of patients with dependence on heroine, cocaine, and other opiates, showing better outcomes than those obtained in previous trials.