Thiamine to reduce brain injury in adults with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study investigates whether thiamine supplementation can reduce alcohol-related brain injury in outpatients with alcohol use disorder. Participants are adults aged 18 to 65 who consume at least 40 g of alcohol daily and are covered by health insurance. The study uses thiamine administration as the intervention and will monitor for neurological and biomarker changes related to brain injury, with safety checks and eligibility criteria designed to exclude those with recent thiamine use, certain comorbid conditions, or recent severe CNS events. The trial is conducted at Hospital Lariboisière Fernand-Widal in Paris under the Institute national de la Santé et de la Recherche Médicale in France.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient with moderate to severe alcohol use disorder
* Reported daily consumption of at least 40g of alcohol
* Patients aged 18 to 65
* Urine pregnancy test performed prior to inclusion for women of childbearing age
* Contraceptive method (with a Pearl index ≤10) for women of childbearing age who are sexually active
* Covered by a health insurance plan or medical aid program

Non-inclusion Criteria:

* Thiamine intake during the previous month
* Planned hospitalization during the study period
* Surgery with general anesthesia planned during the study period
* History of Wernicke encephalopathy, delirium tremens or severe cognitive impairment
* Epileptic seizure, stroke or severe head injury in the last three months
* Active infection with HIV, hepatitis C virus, or syphilis
* Severe hepatic impairment (prothrombin ratio below 50%)
* Severe renal impairment (glomerular filtration rate \<30 mL/min/1.73 m²)
* Persons subject to legal protection measures or under guardianship
* Pregnant women and breastfeeding women
* Known or suspected allergy to any of the components of the experimental drug Bevitine (thiamine)
* Known or suspected wheat allergy (other than celiac disease)
* Fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency

Where it's running

• Hospital Lariboisière Fernand-Widal
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Virgile Clergue-Duval, MD PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Virgile Clergue-Duval, MD PhD
• Email: virgile.clergue-duval@aphp.fr
• Phone: 0033140054214

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emotional Reactivity in Severe Alcohol Use Disorder and Depression Using Eye-Tracking and Physiological Measures

  This study tests how people with severe alcohol use disorder, major depressive disorder, both conditions, or neither, recognize and react to emotions using eye-tracking and physiological data.

  Recruiting Université Catholique de Louvain · Brussels, Belgium · NCT07925281

• Digital Recovery Support for Black adults with Alcohol Use Disorder in Detroit

  This study tests whether a smartphone-based digital recovery program helps Black or African American adults in Detroit maintain their recovery from alcohol use disorder.

  Recruiting Brandeis University · Detroit, Michigan · NCT07724275

• Path180: a computer-based skills program to help teens reduce alcohol use

  This 8-week trial tests Path180, a computer-based skills training, added to usual care for teens 13–19 with alcohol use disorder to see if it improves daily-life coping skills and outcomes.

  Recruiting Brown University · Providence, Rhode Island · NCT07713251

• Effects of comorbidity on people with severe mental illness

  This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07692984

• Psilocybin in Alcohol Use Disorder with Depression (Relapse Prevention)

  This study tests whether higher-dose psilocybin-assisted psychotherapy helps prevent relapse in adults with severe alcohol use disorder and depressive symptoms after detox.

  Recruiting Phase 3 Centre Hospitalier Universitaire de Nīmes · Bayonne and 7 other locations · NCT07638553

• Liver health check plus brief alcohol support for hospitalized adults

  In hospitalized adults who drink harmfully, doctors will test liver stiffness and offer personalized brief alcohol advice to see if it helps reduce drinking compared with usual care.

  Recruiting Oslo University Hospital · Bergen and 7 other locations · NCT07637539

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.