Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder

NCT04773691 | Recruiting

• 1 other identifier: TROJAK PHRCI 2014
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The fight against alcoholism is a public health priority. Around 15 million Europeans and 10 million North Americans are alcohol dependent. Worldwide, 1 death out of 25 is thought to be attributed to alcohol. In France, the latest published data on alcohol-related mortality indicates that there were 49,000 alcohol-related deaths in 2009. Alcohol is thought to be the leading cause of hospitalisation for French people, and its social cost is estimated at 37.4 billion euros. However, few patients with an alcohol use disorder are treated: less than 8% in Europe and less than 10.5% in the USA receive appropriate treatment for their alcohol problem. This low rate of treatment is mainly due to the fact that these patients are not ready to stop drinking. They are therefore not attracted by the goal of abstinence that is required by most current therapies and drug treatments. The arrival of new treatments aimed at reducing consumption (rather than abstinence) should make treatment more attractive. To date, nalmefen is the only treatment marketed for this indication. Baclofen should be marketed in 2020, but with restrictive prescription criteria. In this new strategy to reduce consumption, brain stimulation could play a predominant role as an alternative or complementary therapy. Indeed, functional brain imaging techniques have made it possible to visualise the cortical regions involved in craving, in particular the dorsolateral prefrontal cortex (DLPFC). Craving, i.e. the irrepressible desire to consume, is often at the origin of consumption and relapse. Stimulation of the dorsolateral prefrontal cortex with non-invasive cerebral stimulation techniques, such as repeated transcranial magnetic stimulation (rTMS), has provided encouraging results for the reduction of cravings in all addictive behaviours (alcohol, tobacco, cocaine, food). Furthermore, stimulation of the DLPFC seems to modulate decision-making processes: it may thus reduce impulsivity and strengthen inhibitory control, leading to a reduction in substance use. The hypothesis to be tested is that repeated transcranial magnetic stimulation allows a reduction in alcohol consumption in patients with an alcohol use disorder.

Conditions

Alcoholism; rTMS Stimulation

Outcome Measures

Primary Outcomes (2)

• total alcohol consumption (g/d)

  total alcohol consumption (g/d), measured by average daily consumption

  through study completion, an average of 1 month

• number of days of high consumption

  reduction in the number of days of high consumption (≥ 60 g/d for men, ≥ 40 g/d for women)

  through study completion, an average of 1 month

Study Arms (2)

test group

EXPERIMENTAL

Device: Active rTMS; Other: Questionnaires; Device: Breathalyzer

control group

PLACEBO COMPARATOR

Device: Placebo rTMS; Other: Questionnaires; Device: Breathalyzer

Interventions

Active rTMS DEVICE

Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days. A total of 10 sessions. Stimulation parameters: 10 Hz, 1000 pulses per session, 110% of SM, cortical target: right DLPFC

test group

Placebo rTMS DEVICE

Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days. A total of 10 sessions. Stimulation parameters: delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation.

control group

Questionnaires OTHER

questionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA

control group; test group

Breathalyzer DEVICE

estimation of blood alcohol level

control group; test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a person who has given his or her free, written and informed consent
• adult patient
• patient with mild to severe alcohol use disorder according to DSM-5 criteria
• voluntary patient to reduce alcohol consumption
• patient who has already made at least one attempt at alcohol withdrawal (failure or relapse), or at reducing consumption

You may not qualify if:

• 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 with an exhaled alcohol level \> 0 milligrams/litre inclusive
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

• Petit B, Soudry-Faure A, Jeanjean L, Foucher J, Lalanne L, Carpentier M, Jonval L, Allard C, Ravier M, Mohamed AB, Meille V, Trojak B. Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial. Trials. 2022 Jan 12;23(1):33. doi: 10.1186/s13063-021-05940-z.

  PMID: 35022086 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Surveys and Questionnaires; Breath Tests

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)