Clinical Trial: A Clinical Trial on the Efficacy of tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients (REDSTIM)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Double-blind Clinical Trial on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients With Alcohol Use Disorder

Brief Summary: 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.

Detailed Summary:

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).

Sponsor: Centre Hospitalier Universitaire Dijon

Current Primary Outcome:

• Change from baseline to week 24 in Total Alcohol Consumption (TAC) [ Time Frame: 24 weeks following the treatment ]

  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)

• Change from baseline to week 24 in Number of Heavy Drinking Days (HDD). [ Time Frame: 24 weeks following the treatment ]
  HDD was defined as more than 60 grams of pure alcohol in men and 40 grams in women

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  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)
• 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 [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  measured by the Alcohol Dependence Scale (ADS)
• Change in craving/urge to drink assessment [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
• 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 [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  SF 12
• Change in validated biochemical alcohol consumption markers [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
• Change in scores for anxiety and depression scales [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Hamilton Depression Rating Scale (HDRS-21)
• For smokers: change in number of cigarettes smoked/day and craving for tobacco [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ),
• Change in cognitive assessment [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Montreal Cognitive Assessment (MOCA)

Original Secondary Outcome:

• Proportion of subjects with a significant categorical shift in World health organization (WHO) risk levels of drinking [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  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)
• 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 [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  measured by the Alcohol Dependence Scale (ADS)
• Change in craving/urge to drink assessment [ Time Frame: Change from baseline during the entire treatment period, and then for each 4-week period after the treatment up to week 24 ]
  using Visual Analogue Scale (VAS) the Obsessive Compulsive Drinking Scale (OCDS)
• 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 [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  SF 36
• Change in validated biochemical alcohol consumption markers [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Gamma Glutamyl transferase (GGT), Mean Corpuscular Volume (MCV), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT) and Carbohydrate Deficient Transferrin (CDT%)
• Change in scores for anxiety and depression scales [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Hamilton Anxiety (HAM-A), Hamilton Depression Rating Scale (HDRS-21)
• For smokers: change in number of cigarettes smoked/day and craving for tobacco [ Time Frame: Change from baseline at week 4, week 12, and week 24 after the treatment ]
  Visual Analogue Scale (VAS), Tobacco Craving Questionnaire (TCQ), Questionnaire of Smoking Urge (QSU)

Information By: Centre Hospitalier Universitaire Dijon

Dates:
Date Received: July 15, 2015
Date Started: September 2015
Date Completion:
Last Updated: July 29, 2016
Last Verified: June 2015