The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol consumption within the 24 weeks following the treatment in non-abstinent patients with alcohol use disorders versus placebo.
340 patients are expected and randomized in two groups: 170 patients with active tDCS and 170 patients with placebo tDCS Visit 1 : Patients will received one daily session (13:20:13) during 5 consecutive days: current flows continuously twice for 13min with a rest interval (no stimulation) of 20 min. Visit 1 to 7 : Change from baseline to week 24 in Total Alcohol Consumption (TAC) and Number of Heavy Drinking Days (HDD) will be evaluated in each group. Evaluation on alcohol consumption (daily drinking diary, alcohol craving and severity) and other assessments like mood, quality of life, safety. The co-primary outcome of change from baseline in total alcohol consumption AND reduction in number of heavy drinking days at 6 months after treatment and its association with tDCS will be analyzed under the intention-to-treat principle using a mixed model repeated measures (8 times).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
339
One daily session (13:20:13) : active current flows continuously twice for 13 minutes with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)
One daily session (13:20:13) : inactive current flows continuously twice for 13 with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)
CHU de DIJON
Dijon, France
Change from baseline to week 24 in Total Alcohol Consumption (TAC)
Baseline was defined as alcohol consumption during the 28 days before randomization (visit 1). Baseline will be determined using TLFB (alcohol Timeline Follow-Back), a validated method that retrospectively obtains estimates of daily drinking using a calendar. TAC was defined as mean daily alcohol consumption over 28 days (in g/day)
Time frame: 24 weeks following the treatment
Change from baseline to week 24 in Number of Heavy Drinking Days (HDD).
HDD was defined as more than 60 grams of pure alcohol in men and 40 grams in women
Time frame: 24 weeks following the treatment
Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking
low risk (Men≤40g/d ; Women≤20g/d), medium risk (Men≤60g/d; Women≤40g/d), high risk (Men≤100g/d; Women≤60g/d, very high risk (Men\>100g/d; Women\>60g/d; WHO, 2010)
Time frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Proportion of subjects with a 50%, 70% and 90% reduction in alcohol consumption as well as the proportion of patients achieving maintained abstinence (cumulative abstinence duration)
Time frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in the level of alcohol dependence severity
measured by the Alcohol Dependence Scale (ADS)
Time frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in craving/urge to drink assessment
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using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I)
Time frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Number of patients with Adverse Events (AEs)
Time frame: during the entire treatment period, and then for each 4-week period after the treatment up to week 24
Change in Quality of Life
SF 12
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Change in validated biochemical alcohol consumption markers
Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Change in scores for anxiety and depression scales
Hamilton Depression Rating Scale (HDRS-21)
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment
For smokers: change in number of cigarettes smoked/day and craving for tobacco
Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment
Change in cognitive assessment
Montreal Cognitive Assessment (MOCA)
Time frame: Change from baseline at week 4, week 12, and week 24 after the treatment