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Effect of Hydroxocobalamin Acetate, Thiamine Hydrochloride, and Pyridoxine Hydrochloride Supplementation on Brain Injury in Outpatients with Alcohol Use Disorder

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

People with chronic heavy drinking, referred to as Alcoholism, can develop damage to the brain over time. The study is testing whether adding a vitamin B1 supplement, known as Thiamine, to the usual care can protect the brain and lessen this injury. The vitamin will be taken by mouth as tablets over a short period.

The aim of the trial is to see if a 14‑day course of thiamine can reduce signs of brain injury. Participants will be randomly placed into two groups: one that receives the thiamine tablets and another that does not receive any extra supplement. Blood samples will be collected at the start of the study and again after two weeks to measure substances that indicate brain cell damage, such as light neurofilaments (NFL), a protein that appears in the blood when brain cells are harmed, as well as other markers like GFAP and Tau. Participants will also answer simple questions about their drinking habits and any withdrawal symptoms, and they may complete a brief memory and thinking test called the MoCA. The study follows each person for about two weeks, after which the collected information will be compared between the two groups to determine whether thiamine had a beneficial effect.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit (day 0)

    On the first day of the study you attend a clinic visit. during this visit a blood sample is taken to measure plasma nfl, gfap and total tau. you also complete brief questionnaires about your health and alcohol use.

    After the assessments you receive a supply of oral thiamine tablets. each tablet contains 1000 mg of thiamine. the total amount provided is enough for 14 days of treatment.

  2. Step 2

    Daily thiamine supplementation

    Each day you swallow one thiamine tablet by mouth with water. the tablet is taken once daily, at any convenient time, for a total of 14 consecutive days.

    The tablets are to be taken exactly as instructed; no other vitamins or supplements are required as part of the study.

  3. Step 3

    Adherence monitoring

    You are asked to keep the tablets in a safe place and to take one tablet each day. at the final visit the remaining tablets are counted to assess how many doses were taken.

  4. Step 4

    Follow‑up visit (day 14‑16)

    Between day 14 and day 16 you return to the clinic for a follow‑up visit. another blood sample is drawn to measure the same markers (plasma nfl, gfap, total tau) and the questionnaires are repeated.

    The purpose of this visit is to compare the results with those obtained at the baseline visit.

  5. Step 5

    Completion of study procedures

    After the follow‑up visit all study procedures are finished. the collected data are used for analysis of the effect of the 14‑day thiamine course.

Who can join the trial?

6 criteria

  • Be currently receiving treatment for moderate or severe alcohol use disorder (a condition where drinking is hard to control).
  • Drink at least 40 grams of alcohol each day (about three standard drinks).
  • Be between 18 and 65 years old.
  • For women who could become pregnant, have a urine pregnancy test done before joining the study (a test that checks for pregnancy using a urine sample).
  • Women who could become pregnant and are sexually active must be using contraception (methods to prevent pregnancy, such as birth control pills or condoms).
  • Be enrolled in, or eligible for, a social security or Aide Médicale d’État health program (government health coverage programs).

Who cannot join the trial?

13 criteria

  • You have taken thiamine (a vitamin B1 supplement) in the past month.
  • You are pregnant or breastfeeding.
  • You have a known or suspected allergy to any ingredient in the study drug Bevitine (which contains thiamine).
  • You have a known or suspected wheat allergy (different from celiac disease).
  • You have fructose intolerance, glucose‑galactose malabsorption syndrome, or sucrase‑isomaltase deficiency—all are conditions where your body cannot properly digest certain sugars.
  • You plan to be hospitalized at any time during the study period.
  • You have a scheduled surgical procedure that requires general anesthesia (medicine that makes you unconscious) during the study period.
  • You have a history of Wernicke’s encephalopathy, delirium tremens, or severe cognitive impairment (significant problems with thinking and memory).
  • You have had an epileptic seizure, a stroke, or a serious head trauma within the last three months.
  • You have an active infection with HIV, hepatitis C virus (HCV), or syphilis (blood‑borne infections).
  • Your glomerular filtration rate (GFR), a test of kidney function, is less than 50% of normal.
  • You have severe kidney problems, defined as an estimated eGFR lower than 30 mL/min/1.73 m².
  • You are under legal guardianship, conservatorship, or trusteeship (a court‑appointed person makes decisions for you).
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Investigated drugs

Thiamine is a vitamin B1 supplement taken by mouth. In this study it is given for two weeks to see if it can lower signs of brain injury in people who drink heavily. Thiamine helps the brain produce energy and protects nerve cells. The product also contains small amounts of vitamin B12 and vitamin B6, which work together with thiamine to support nerve health. Participants will take the supplement daily, and researchers will check a blood marker of brain damage to see if it improves.

What is already known about the treatment

Thiamine (Vit B1) - The medication is taken orally as a tablet that contains thiamine hydrochloride along with small amounts of hydroxocobalamin and pyridoxine, and the study uses a daily dose of 1000 mg. Thiamine is a well‑known water‑soluble vitamin that is widely available as a dietary supplement and is recognized in medical literature for treating deficiency. It is primarily used to prevent or treat thiamine deficiency in people with chronic alcohol use, helping to reduce nerve and brain damage. At the molecular level thiamine acts as a co‑factor for enzymes that convert sugars into energy, supporting normal nerve function, and it is classified as a vitamin B1 (water‑soluble vitamin) supplement.

Investigated diseases

Alcohol use disorder - Alcohol use disorder is a chronic condition characterized by the compulsive consumption of alcoholic beverages despite negative consequences. It develops gradually as the brain's reward pathways become altered, leading to increased tolerance and dependence. Over time, the individual may experience cravings, difficulty controlling intake, and withdrawal symptoms when alcohol is not used. The disorder often progresses from occasional heavy drinking to regular, excessive use that interferes with daily responsibilities. Continued use can result in physical changes such as reduced liver function and cognitive effects, while psychological dependence deepens.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524148-36-00Protocol codeC25-96Estimated enrolment60 patientsSponsorInstitut National De La Sante Et De La Recherche Medicale

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