AlcoholismALCOSTIMNCT04773691
Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder
A study testing Active rTMS, Questionnaires and Breathalyzer in people with Alcoholism and rTMS Stimulation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, rTMS Stimulation
- What is being tested?
- Active rTMS, Questionnaires and Breathalyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- patient with an exhaled alcohol level > 0 milligrams/litre 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 60g or more for men and 40g 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 40g/day for men and 40g 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
benoit TROJAK, 0380293769 ext. +33, benoit.trojak@chu-dijon.fr
About this study
Official title: Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study
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.
Read more
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
- Being tested
- Active rTMS, Placebo rTMS, Questionnaires, Breathalyzer
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
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
Placebo rTMSDevice
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.
QuestionnairesOther
questionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA
BreathalyzerDevice
estimation of blood alcohol level
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Not described Receives: Device: Active rTMS; Other: Questionnaires; Device: Breathalyzer |
| control group | Placebo comparator | Not described Receives: Device: Placebo rTMS; Other: Questionnaires; Device: Breathalyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
total alcohol consumption (g/d)
total alcohol consumption (g/d), measured by average daily consumption
Measured: 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)
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Mar 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773691
- Sponsor's protocol ID
- TROJAK PHRCI 2014
- Acronym
- ALCOSTIM
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35022086
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04773691
- Acronym / sponsor ID
- ALCOSTIM / TROJAK PHRCI 2014
- Conditions
- Alcoholism, rTMS Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: Active rTMS, Other: Questionnaires, Device: Breathalyzer |
| control group | Placebo comparator | Device: Placebo rTMS, Other: Questionnaires, Device: Breathalyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSTwo 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 | Device | test group |
| Placebo rTMSTwo 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. | Device | control group |
| Questionnairesquestionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA | Other | control group, test group |
| Breathalyzerestimation of blood alcohol level | Device | control group, test group |
Primary outcome
total alcohol consumption (g/d)
Time frame: through study completion, an average of 1 month
total alcohol consumption (g/d), measured by average daily consumption
number of days of high consumption
Time frame: through study completion, an average of 1 month
reduction in the number of days of high consumption (≥ 60 g/d for men, ≥ 40 g/d for women)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 35022086Petit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS, Questionnaires and Breathalyzer in people with Alcoholism and rTMS Stimulation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total alcohol consumption (g/d) (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.