Alcoholic Intoxication, Chronic Clinical Trial
— REDSTIMOfficial 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
Verified date | February 2024 |
Source | Centre Hospitalier Universitaire Dijon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 339 |
Est. completion date | December 23, 2021 |
Est. primary completion date | December 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have signed and dated the informed consent form - Male and female patients over 18 years of age - Patients who meet at least two criteria for Alcohol Use Disorder as defined in the Diagnostic and statistical Manual of mental disorder (DSM-5) - Patients who are motivated to reduce their alcohol consumption - At least one attempt to achieve abstinence (unsuccessful or relapse) or to reduce alcohol consumption Exclusion Criteria: - Breath-alcohol concentration > 0 milligrams per litre of exhaled air at randomization (visit 1) - < 6 heavy drinking days in the 4 weeks before randomization (European Medicines Agency, 2010; a day with alcohol consumption = 60 g for men and =40 g for women) - An average alcohol consumption below medium risk level according to World health Organization (WHO) in the 4 weeks before screening (WHO, 2000; =40g/day for men; =20g/day for women), - More than 3-days abstinence prior to screening and randomization (screening visit and visit 1) - A Revised Clinical Institute Withdrawal Assessment for Alcohol score = 10 (indicating the need for medication supported detoxification) at randomization (visit 1) - Concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefene (<1 month) - History of pre-delirium tremens and delirium tremens - DSM-5 substance use disorder other than alcohol or nicotine use disorder - Acute psychiatric disorders that have required hospitalisation and/or immediate adjustment of psychotropic medications - Major depression, as defined by Hamilton Depression (HDRS) scale greater than or equal to 24 - Recent change in psychotropic medication (< 1 month) - Severe chronic psychiatric disorders including schizophrenia, paranoia and bipolar disorder type I and II - Advanced liver, kidney, cardiac, or pulmonary disease or other acute serious or unstable medical condition that would compromise patient's participation in the study according to physician's judgment - Contra-indications to tDCS: metal in the head, implanted brain medical devices - Women who are pregnant or lactating - Women of childbearing potential with a positive urine ß-human chorionic gonadotrophin pregnancy test at randomization (visit 1) - Concurrent participation in other trial - Employees of the investigator or trial site - Patients protected by law - Persons who are not covered by national health insurance - Patients, in the opinion of the investigation, not able to complete the TLFB and to complete their daily alcohol consumption in a diary (derived from the TLFB) during the 3 months of the study. - Patients who refused to sign "safety" agreement |
Country | Name | City | State |
---|---|---|---|
France | CHU de DIJON | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Change in Quality of Life | SF 12 | Change from baseline at week 4, week 12, and week 24 after the treatment | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in cognitive assessment | Montreal Cognitive Assessment (MOCA) | Change from baseline at week 4, week 12, and week 24 after the treatment |
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