Primary registry and trial identifying number	Clinicaltrials.gov NCT04773691
Date of registration in primary registry	February 26th, 2021
Source(s) of monetary or material support	National Hospital Research Program 2014 of the French Ministry of Health
Primary sponsor	National Hospital Research Program 2014 of the French Ministry of Health
Secondary sponsor	N/A
Contact for public queries	Dr Benjamin Petit, M.D., benjamin.petit@chu-dijon.fr
Contact for scientific queries	Dr Benjamin Petit, M.D., benjamin.petit@chu-dijon.fr
Public title	Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial
Scientific title	Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial
Countries of recruitment	France
Health condition(s) or problem(s) studied	Alcohol use disorder
Intervention(s)	Active rTMS (1,000 pulses per session, 2 sessions per day, 5 days)
	Sham rTMS
Key inclusion and exclusion criteria	Ages eligible for study: ≥ 18 years Genders eligible for study: both Accepts healthy volunteers: no
	Inclusion criteria: meeting the criteria for mild to severe AUD as defined in the Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5); wishing to reduce their alcohol consumption; and having experienced at least one prior attempt to achieve abstinence (unsuccessful or relapse).
	Exclusion criteria: - person who is not affiliated to or not a beneficiary of national health insurance - person subject to a legal protection measure (curatorship, guardianship) - person subject to a legal safeguard measure - pregnant, parturient or breastfeeding women - adult unable to express consent - patient of childbearing age with a positive pregnancy test at inclusion - patient with an exhaled alcohol level > 0 mg/l inclusive - patient with heavy alcohol consumption <  6 days in the 4 weeks prior to inclusion (European Medicine Agency, 2010; one day with alcohol consumption of 60 g or more for men and 40 g for women) - patient with an average alcohol consumption below the WHO average risk level in the 4 weeks prior to inclusion (WHO, 2000, less than or equal to 40 g/day for men and 40 g for women) - patient being abstinent more than 5 days before inclusion - patient with a CIWA (Clinical Institute Withdrawal Evaluation: assessment of the severity of alcohol withdrawal) score greater than or equal to 10 at inclusion - Patient with concomitant treatment with disulfiram, acamprosate, topiramate, baclofen, naltrexone, and nalmefen (< 1 month) - Patient with a history or presence of pre-delirium tremens or delirium tremens - Patient with a substance use disorder (DSM-5 criteria) with psychoactive substances other than tobacco and alcohol. - Patient with acute psychiatric disorders requiring hospitalization and/or immediate adjustment of psychotropic medication - Patient with severe depression, defined by a score of 24 or more on the Hamilton Depression Scale (HAM-D). - Patient who has had a recent change (< 1 month) in the prescription of psychotropic treatment - Patient with severe and/or chronic psychiatric disorders, including schizophrenia, paranoia and bipolar disorders type I and II - Patient with severe heart, kidney, liver or lung failure or other condition that the doctor believes could compromise the patient's participation in the study. - Patient with a contraindication to the practice of rTMS; personal history of seizure, pacemaker, neurosurgical clips, carotid or aortic clips, heart valves, hearing aid, ventricular bypass valve, sutures with wires or staples, foreign bodies in the eye, shrapnel, other prosthesis or cephalic ferromagnetic material. - Patient simultaneously participating in another therapeutic trial - Patient employed by the investigator or trial site - Patient who, according to the investigator, is unable to complete a consumption diary and follow up visits for 6 months - Patient refusing to sign the "safety contract "* specific to the study
Study type	Interventional
	Allocation: randomized intervention model. Parallel assignment. Masking: double blind (patient, investigator)
	Primary purpose: treatment
Date of first enrolment	March 2021
Target sample size	144
Recruitment status	Recruiting
Primary outcome(s)	change in TAC and number of HDD from baseline to week 4
Key secondary outcomes	change from baseline to the end of the rTMS sessions, and then for multiple interim endpoints after the treatment up to week 24: - TAC (g/day) and number of HDD - Proportion of subjects with a significant categorical shift in World Health Organization (WHO) risk levels of drinking: low risk (H≤40 g/d; F≤20 g/d), medium risk (H≤60 g/d; F≤40 g/d), high risk (H≤100 g/d; F≤60 g/d, and very high risk (H> 100 g/d; F> 60 g/d) [22] - Proportion of subjects with a 50%, 70% and 90% reduction in alcohol consumption as well as the proportion of patients who potentially achieve abstinence - Level of alcohol dependence severity (alcohol dependence scale) - Craving/urge to drink assessment (visual analogue scale, obsessive compulsive drinking scale) - Clinical global impression-severity and improvement - Scores for depression scales (HAM-D – 17 items) - Quality of Life (short form health survey – 12 items) - Biochemical alcohol consumption markers (gamma glutamyl transferase, mean corpuscular volume, aspartate aminotransferase, alanine aminotransferase and carbohydrate deficient transferrin) - Cognitive assessment (Montreal cognitive assessment) - Number of cigarettes smoked/day and craving for tobacco (visual analogue scale, tobacco craving questionnaire) for smokers.