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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS group | Experimental | Active tDCS |
|
| Placebo tDCS group | Placebo Comparator | Placebo tDCS : Inactive tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 24 weeks following the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de DIJON | Dijon | 21079 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27188795 | Derived | Trojak B, Soudry-Faure A, Abello N, Carpentier M, Jonval L, Allard C, Sabsevari F, Blaise E, Ponavoy E, Bonin B, Meille V, Chauvet-Gelinier JC. Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):250. doi: 10.1186/s13063-016-1363-8. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo tDCS | Device | 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) |
|
| 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) | 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) | 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 | using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS) | 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) | 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) | 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 | 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%) | 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) | 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), | Change from baseline at week 4, week 12, and week 24 after the treatment |
| Change in cognitive assessment | Montreal Cognitive Assessment (MOCA) | Change from baseline at week 4, week 12, and week 24 after the treatment |