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Randomised open-label pilot Study on Thiamine supplementation to REduce braiN injury associated with chronic Alcohol use in outpatients with alcohol use disorder : STRENA
EU CTIS ID: 2025-524148-36-00
What this study is testing
The primary objective is to evaluate the efficacy of a 14-day course of thiamine supplementation in reducing brain damage, as measured by plasma levels of light neurofilaments (NFL), in patients who are chronic alcohol users and have an alcohol use disorder, using an intention-to-treat (ITT) analysis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients being treated for moderate or severe alcohol use disorder
- Reported daily alcohol consumption of at least 40 g
- Patients aged 18 to 65
- A urine pregnancy test performed prior to enrollment for women of childbearing age
- Use of contraception for women of childbearing age who are sexually active
- Enrollment in a social security program or the Aide Médicale d’État program, or eligibility for such a program.
You likely can't join if
- Use of thiamine within the past month
- Pregnant and breastfeeding women
- Known or suspected allergy to any of the ingredients in the investigational drug Bevitine (thiamine)
- Known or suspected wheat allergy (other than celiac disease)
- Fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency
- Planned hospitalization during the study period
See the full eligibility criteria
- Patients being treated for moderate or severe alcohol use disorder
- Reported daily alcohol consumption of at least 40 g
- Patients aged 18 to 65
- A urine pregnancy test performed prior to enrollment for women of childbearing age
- Use of contraception for women of childbearing age who are sexually active
- Enrollment in a social security program or the Aide Médicale d’État program, or eligibility for such a program.
- Use of thiamine within the past month
- Pregnant and breastfeeding women
- Known or suspected allergy to any of the ingredients in the investigational drug Bevitine (thiamine)
- Known or suspected wheat allergy (other than celiac disease)
- Fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency
- Planned hospitalization during the study period
- Scheduled surgical procedure under general anesthesia during the study period
- History of Wernicke’s encephalopathy, delirium tremens, or severe cognitive impairment
- Epileptic seizure, stroke, or severe head trauma within the last three months
- Active infection with HIV, hepatitis C virus (HCV), or syphilis
- Glomerular filtration rate (GFR) <50%
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Individuals subject to legal guardianship, conservatorship, or trusteeship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.