Alcoholic Intoxication Clinical Trial
Official title:
Interest of tDCS in Help for Supporting Alcohol Abstinence
The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of abstinence at 3 months.
The study takes place at one site (Henri Laborit Hospital, Poitiers, France) and is comparative, randomized and controlled. There are 2 groups : one group is receiving sessions of active tDCS (active group) whereas the second group is receiving sham (placebo) sessions (control group). Patients are randomized either in the active group or in the control group with a 1:1 ratio. An unblinded investigator is responsible of the stimulation part and could not evaluate the patients. The other investigators are blinded and could evaluate the patients. The study is going to evaluate the effect produces by stimulations in the two groups. In the placebo group, after the intensity has reached its maximal intensity (the same as in the active group), the stimulation is stopped after few seconds (30 seconds in mostly studies). This process allow patients in the placebo group to feel the same sensations as patients in the active group (indeed, tingles and itches are felt only during the first few seconds of stimulation). The poor duration of stimulation do not produces clinical effect. The study begins after a withdrawal period of 7 days +/- 3 days with 10 stimulations of 2 mA during 20 minutes from Monday to Friday during 2 weeks. Following these stimulation sessions, the patient will have 5 follow-up visits on site with an investigator and 2 phone follow-up. Visits: - Pre-inclusion visit - V0 visit (inclusion visit): takes place at the earliest 48 hours after stopping benzodiazepines used in the withdrawal period. - Treatment (weeks 0 and 1): 5 days of treatment per week during 2 weeks 2 arms : sham (placebo, 10 stimulations) vs active (10 stimulations of 2 mA) - Visit 1 (Week 4) : short nurse consultation - Visit 2 (Week 6) : short medical consultation - Visit 3 (Week 10) : short medical consultation - Visit 4 (Week 14) : long medical consultation - Visit 5 (Week 18) : nurse phone follow-up - Visit 6 (Week 22) : nurse phone follow-up - Visit 7 (Week 26) : long medical consultation ;
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