AuthorisedTherapeutic exploratory (Phase II)Interventional

Randomised open-label pilot Study on Thiamine supplementation to REduce braiN injury associated with chronic Alcohol use in outpatients with alcohol use disorder : STRENA

Long-term heavy drinking can harm the brain and make it difficult for the body to absorb essential nutrients, particularly vitamin B1 (thiamine). Without enough thiamine, brain and nerve cells become stressed and can suffer damage. The STRENA clinical trial is investigating whether giving thiamine supplements to adults receiving outpatient care for alcohol use disorder can protect their brain health. Participants are randomly placed into two groups: one receives daily thiamine supplements for about 14 days, while the other receives their normal care without the extra supplement. Doctors will collect blood samples at the beginning and end of the two weeks. They will measure tiny proteins called neurofilaments that leak into the bloodstream when brain cells are injured. By comparing the two groups, researchers hope to see if this simple vitamin can guard brain cells against further injury.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut National De La Sante Et De La Recherche Medicale

Enrolment target

Start

29 Jun 2026

Alcoholism

What is this study about?

Drinking large amounts of alcohol over a long period can take a serious toll on the body and the brain. One major issue is that alcohol makes it difficult for the digestive system to absorb thiamine, also known as vitamin B1. Thiamine is essential because brain cells need it to produce energy and work properly. When thiamine levels drop too low, brain cells can become damaged, leading to memory problems, confusion, and other health issues.

The STRENA study aims to find out if giving thiamine supplements to outpatients with alcohol use disorder can quickly protect their brain cells. Researchers want to see if boosting thiamine levels reduces the ongoing cell stress and injury linked to heavy drinking. This is an exploratory study designed to give doctors clearer evidence on how effective this common vitamin really is.

To find out if the treatment works, doctors check the blood for microscopic signs of nerve health. When brain and nerve cells are injured, tiny pieces of their internal structure—such as neurofilament light proteins—spill out into the bloodstream. By measuring these proteins on day one and again after two weeks, the team can see whether people taking thiamine have lower levels of nerve damage markers compared to those who did not receive the supplement.

Key takeaways

Tests whether vitamin B1 (thiamine) supplements protect brain cells from alcohol-related injury.
Open to adults aged 18 and older receiving outpatient support for alcohol use.
Lasts approximately two weeks with two clinic visits and routine blood tests.
Compares a group taking daily thiamine against a group receiving standard care.
Taking part is voluntary and does not change your right to usual medical care.

Who may be eligible?

This trial is designed for adults aged 18 and over who have alcohol use disorder and are receiving care as outpatients. Outpatient care means you visit a clinic or medical centre for support but do not need to stay overnight in a hospital.

Both men and women can join. To take part, you need to be able to attend the initial clinic visit and return for a follow-up visit approximately two weeks later, as well as agree to have standard blood tests taken.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Are you currently receiving outpatient care or support for alcohol use?
Can you attend an initial clinic appointment and a follow-up visit two weeks later?
Are you comfortable having routine blood tests taken on two occasions?
Are you willing to take study tablets daily if assigned to the thiamine group?

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts around two weeks (between 14 and 16 days). On your first day, you will visit the clinic for an assessment, and a healthcare professional will take a small blood sample. You will then be randomly assigned by a computer to either take daily thiamine tablets or continue your usual care without the study supplement. Neither you nor your doctor can choose your group. After about 14 days, you will return to the clinic for a second blood sample and a brief review of your general health and drinking habits. Once this second visit is complete, your part in the trial ends.

Potential risks and benefits

Taking thiamine may help protect your brain cells, although direct personal benefits cannot be guaranteed. The study will also help doctors better understand how to protect brain health in people recovering from alcohol dependence. Thiamine is a standard vitamin that is generally safe and well tolerated. The main physical discomfort comes from having blood taken, which can occasionally cause mild bruising, tenderness, or light-headedness. Taking part is completely voluntary, and you are free to leave the study at any time without your standard medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is thiamine?

Thiamine is another name for vitamin B1. It is a natural nutrient found in foods like whole grains, nuts, and meat, and your nerves need it to stay healthy.

Why do you need to test my blood?

When nerve cells in the brain are stressed or injured, tiny proteins leak into the blood. Testing your blood allows doctors to track brain cell health without needing brain scans.

Will I definitely receive the thiamine pills?

No. A computer puts participants into one of two groups at random. One group receives the thiamine supplement, and the other group receives standard care without it.

Do I have to stay overnight in hospital?

No. This trial is for outpatients, meaning you only need to visit the clinic for your assessments and tests, then return home.

Can I leave the trial if I change my mind?

Yes. You can leave the study at any point without giving a reason, and your regular medical care will carry on as normal.