Using high-frequency rTMS to help reduce alcohol consumption in patients with alcohol use disorder
Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study
This study is testing whether a special brain treatment can help adults with alcohol use disorder drink less without needing to stop completely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04773691 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of high-frequency repetitive transcranial magnetic stimulation (rTMS) in reducing alcohol consumption among non-abstinent patients diagnosed with alcohol use disorder. The study aims to recruit adult participants who are willing to reduce their alcohol intake and have previously attempted to quit or cut down. Participants will receive either active rTMS or a placebo treatment, alongside assessments through questionnaires and breathalyzer tests to monitor their alcohol consumption. The goal is to provide a new treatment option that focuses on reducing consumption rather than requiring complete abstinence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with mild to severe alcohol use disorder who are motivated to reduce their alcohol consumption.
Not a fit: Patients who are currently abstinent or have heavy alcohol consumption patterns may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new approach for patients struggling with alcohol use disorder by helping them reduce their consumption without the immediate need for abstinence.
How similar studies have performed: Other studies exploring rTMS for addiction treatment have shown promise, suggesting that this approach may be effective, though this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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
Where this trial is running
Dijon
- Chu Dijon Bourogne — Dijon, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.