A Phase 2 interventional study of Thiamine in Alcohol Use Disorder, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 2, Interventional, and Treatment
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Among 94 studies in Alcoholism with a site in France — 24 open to participants now, 25 under way, 1 of them phase 3. Alcoholism · France.
Among the 94 studies in Alcoholism with a site in France, this one is the 48th largest by planned enrollment of the 58 interventional ones that give a count, is one of 8 that started in 2026, is one of 5 in phase 2, reaches primary completion later than 13 of the 24 other live ones, and was the 94th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →24 of the 94 studies in Alcoholism with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 18+
Centre Hospitalier Universitaire de Nīmes · Sites in France
Ages 18+
CHU de Reims · Sites in France
Ages 18–65 · Healthy volunteers
Centre Hospitalier Régional d'Orléans · Sites in France
Ages 18+ · Healthy volunteers
CHU de Reims · Sites in France
Ages 24+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 8 · Phase 4 2
First in 2002; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 153 across the 58 interventional studies, 113 across the 36 observational. Of the 59 that completed or were terminated, 1 (2%) have results posted.
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4 of 94 have an industry lead sponsor. The 10 most frequent:
Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Institut National de la Santé Et de la Recherche Médicale, France has 4 studies filed under Alcoholism — fewer than ten, so there is no comparison to draw.
5 of the studies in Alcoholism with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07369245Versailles HospitalTechniques for Activating Consciousness (TAC) for Outpatients With Moderate to Severe Alcohol Addiction | 2027-07-15 |
| NCT04773691Centre Hospitalier Universitaire DijonEffectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder | 2027-08 |
| NCT06706349Centre Hospitalier Universitaire de BesanconEffect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder | 2027-10 |
| NCT06675539Etablissement Public de Santé Barthélemy DurandValidation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS) | 2027-10 |
| NCT07844720Institut National de la Santé Et de la Recherche Médicale, FranceStudy on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder | 2027-10-22 |
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Among the 94 studies in Alcoholism with a site in France, from their registry updates:
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Chronic alcohol use and alcohol use disorder (AUD) affect 10% of the population in France. They are associated with brain damage and cognitive impairment. These complications have a significant impact on patients' agency, autonomy, and ability to participate in their own care. The investigators need to improve our knowledge of medical treatments that can reduce these risks and harms, beyond providing support to quit drinking or reduce consumption. Nutritional and vitamin deficiencies, particularly thiamine deficiency, are involved in the onset of these complications. Thiamine deficiency causes Wernicke encephalopathy, which can lead to Korsakoff syndrome, a very severe episodic memory disorder. Blood tests to measure thiamine levels are not available in routine medical practice. And it is not currently covered by health insurance in France. However, the systematic prescription of thiamine is recommended during alcohol withdrawal by medical associations and health institutions in France and internationally. However, there are no clinical trial data in the international scientific literature demonstrating the medical benefits and required dosage of systematic supplementation outside the withdrawal period when alcohol use continues or when the patient does not seek alcohol abstinence. People who use multiple psychoactive substances, are in precarious situations, and are receiving treatment for substance use disorders at addiction treatment centers are particularly vulnerable to malnutrition and vitamin deficiencies. In this context, the place of systematic thiamine prescription arises with the aim of reducing risks and brain damage in patients who do not wish to or cannot stop their chronic alcohol use. One of the limitations of previous studies has been the lack of a suitable, reproducible, minimally invasive, inexpensive, and sensitive biomarker of therapeutic response. In this study, the investigators will use plasma neurofilament light chain (NFL) levels, an innovative biomarker. In two recent studies, the study team demonstrated the relevance of this biomarker and its effectiveness in measuring brain suffering in patients with AUD and its kinetics during during inpatient alcohol withdrawal.
The hypothesis the invastigators are working on is that, in a population at high risk of vitamin and nutritional deficiency and who are chronic alcohol users, systematic supplementation with thiamine (vitamin B1) would reduce the brain suffering associated with this deficiency and chronic alcohol use. To answer this question, the investigators conduct a randomized, open-label pilot study. The primary objective is to test the efficacy of thiamine supplementation in reducing brain suffering as measured by plasma NFL level in chronic alcohol users with alcohol use disorder. Secondary objectives are to perform analyses of potential moderating factors of the treatment effect (per-protocol analysis based on good adherence, presence of morning alcohol withdrawal symptoms, reported morning alcohol use) and to use plasma glial fibrillary acidic protein (GFAP) and total plasma total tau protein as alternative biomarkers.
the investigators include adult patients under the age of 65 with alcohol use disorder who are currently chronic active alcohol users reporting daily intake of at least 40g of alcohol, who are being treated in outpatient addiction treatment center, and who may have another substance use disorder as a comorbidity.
This pilot study compares a group receiving 500 mg of thiamine supplementation in the morning and evening (1000 mg/day) over a period of 14 days with a control group receiving no supplementation. In order to measure the brain injury induced and its reduction, the investigators will measure plasma NFL level. Two measurements are performed, before supplementation begins (baseline, on day 0) and after two weeks of supplementation (follow-up visit, on days 14, 15, or 16).
The primary judgment criterion is the change in plasma NFL level between baseline and follow-up, comparatively between the treatment group and the control group (time x treatment interaction). A repeated measures analysis of variance (ANOVA) test, adjusted for age and sex, is used.
Inclusion Criteria:
Non-inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thiamine 500mg twice daily for 14 days
Drug: Thiamine
Thiamine 500mg twice daily for 14 days
Also known as: Bevitine
Change in plasma NFL between the two arms, in ITT analysis
Change in plasma neurofilament light chain (NFL) level between baseline (measured on day 0) and after 14 days of thiamine treatment or no intervention (measured on days 14, 15, or 16), comparatively between the two arms (time x treatment interaction in a repeated measures analysis of variance (ANOVA)), in an intention-to-treat analysis (ITT), adjusted for sex (phenotype, assigned at birth) and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in plasma NFL between the two arms, in PP analysis
Change in plasma NFL level between the two arms (time x treatment interaction in a repeated measures ANOVA), in per protocol analysis (PP), using the threshold of reported intake of 80% of thiamine tablets as the criterion for good adherence (45 tablets out of 56), adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with the presence of morning alcohol withdrawal symptoms on plasma NFL change
Interaction between the presence of morning alcohol withdrawal symptoms and the treatment in NFL level change (time x treatment x symptom interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with reported alcohol use in the morning on plasma NFL change
Interaction between reported alcohol use in the morning and the treatment in plasma NFL level change (time x treatment x morning alcohol use interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in plasma GFAP level between the two arms
Change in plasma glial fibrillary acidic protein (GFAP) level between the two arms (time x treatment interaction in a repeated ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in plasma total tau level between the two arms
Change in plasma total tau level between the two arms (time x treatment interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported daily alcohol intake on plasma NFL change
Interaction between the self-reported daily alcohol intake and the treatment in plasma NFL level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported use of cocaine or psychostimulants during the treatment period on plasma NFL change
Interaction between self-reported use of cocaine or psychostimulants during the treatment period and the treatment in plasma NFL level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma NFL change
Interaction between currently undergoing opioid agonist therapy (OAT) and the treatment in plasma NFL level change (time x treatment x OAT interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma NFL change and alcohol intake change
The association test in linear regression between plasma NFL level change and self-reported daily alcohol intake change, adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma NFL level at baseline
Associations in linear regression, adjusted on age and sex, of plasma NFL level with: * age and sex, * morning alcohol withdrawal symptoms, self-reported at baseline, * cocaine or psychostimulant use disorder with active use in the previous month, self-reported at baseline * OAT * precarity score on questionnaire "EPICES", at baseline * homeless status, having slept on the street at least once in the last month, self-reported at baseline * MoCA score, at baseline * subscale score for "impulsivity" on Difficulties in Emotion Regulation Scale (DERS), at baseline * score on Obsessive Compulsive Drinking Scale (OCDS) at baseline Univariate analyses then multivariate analysis (if p-value \<.10 in univariate)
Time frame: Baseline
Adherence to thiamine treatment
Associations in linear regression of good adherence to thiamine treatment (taking at least 45 of 56 tablets) with: * age and sex * self-reported daily alcohol intake at baseline * morning alcohol withdrawal symptoms, self-reported at baseline * alcohol use in the morning, self-reported at baseline * cocaine or psychostimulant use disorder with active use in the previous month, self-reported at baseline * OAT * precarity score on questionnaire "EPICES", at baseline * MoCA score, at baseline * homeless status, having slept on the street at least once in the last month, self-reported at baseline * subscale score for "impulsivity" on Difficulties in Emotion Regulation Scale (DERS), at baseline * score on Obsessive Compulsive Drinking Scale (OCDS) at baseline Univariate analyses then multivariate analysis (if p-value \<.10 in univariate)
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Montreal Cognitive Assessment (MoCA) at baseline
Associations in linear regression of MoCA with: * age and sex * morning alcohol withdrawal symptoms * cocaine or psychostimulant use disorder with active use in the previous month * OAT * precarity score on questionnaire "EPICES" * homeless status, having slept on the street at least once in the last month * subscale score for "impulsivity" on Difficulties in Emotion Regulation Scale (DERS) * score on Obsessive Compulsive Drinking Scale (OCDS) at baseline Univariate analyses then multivariate analysis (if p-value \<.10 in univariate)
Time frame: Baseline
Change in plasma GFAP between the two arms, in PP analysis
Change in plasma GFAP level between the two arms (time x treatment interaction in a repeated measures ANOVA), in PP, using the threshold of reported intake of 80% of thiamine tablets as the criterion for good adherence (45 tablets out of 56), adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with the presence of morning alcohol withdrawal symptoms on plasma GFAP change
Interaction between the presence of morning alcohol withdrawal symptoms and the treatment in GFAP level change (time x treatment x symptom interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with reported alcohol use in the morning on plasma GFAP change
Interaction between reported alcohol use in the morning and the treatment in plasma GFAP level change (time x treatment x morning alcohol use interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported daily alcohol intake on plasma GFAP change
Interaction between the self-reported daily alcohol intake and the treatment in plasma GFAP level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported use of cocaine or psychostimulants during the treatment period on plasma GFAP change
Interaction between self-reported use of cocaine or psychostimulants during the treatment period and the treatment in plasma GFAP level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma GFAP change
Interaction between currently undergoing opioid agonist therapy (OAT) and the treatment in plasma GFAP level change (time x treatment x OAT interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma GFAP change and alcohol intake change
The association test in linear regression between plasma GFAP level change and self-reported daily alcohol intake change, adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma GFAP level at baseline
Associations in linear regression, adjusted on age and sex, of plasma GFAP level with: * age and sex, * morning alcohol withdrawal symptoms, self-reported at baseline, * cocaine or psychostimulant use disorder with active use in the previous month, self-reported at baseline * OAT * precarity score on questionnaire "EPICES", at baseline * homeless status, having slept on the street at least once in the last month, self-reported at baseline * MoCA score, at baseline * subscale score for "impulsivity" on Difficulties in Emotion Regulation Scale (DERS), at baseline * score on Obsessive Compulsive Drinking Scale (OCDS) at baseline Univariate analyses then multivariate analysis (if p-value \<.10 in univariate)
Time frame: Baseline
Change in plasma total tau between the two arms, in PP analysis
Change in plasma total tau level between the two arms (time x treatment interaction in a repeated measures ANOVA), in PP, using the threshold of reported intake of 80% of thiamine tablets as the criterion for good adherence (45 tablets out of 56), adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with the presence of morning alcohol withdrawal symptoms on plasma total tau change
Interaction between the presence of morning alcohol withdrawal symptoms and the treatment in total tau level change (time x treatment x symptom interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with reported alcohol use in the morning on plasma total tau change
Interaction between reported alcohol use in the morning and the treatment in plasma total tau level change (time x treatment x morning alcohol use interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported daily alcohol intake on plasma total tau change
Interaction between the self-reported daily alcohol intake and the treatment in plasma total tau level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported use of cocaine or psychostimulants during the treatment period on plasma total tau change
Interaction between self-reported use of cocaine or psychostimulants during the treatment period and the treatment in plasma total tau level change (time x treatment x alcohol intake interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma total tau change
Interaction between currently undergoing opioid agonist therapy (OAT) and the treatment in plasma total tau level change (time x treatment x OAT interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma total tau change and alcohol intake change
The association test in linear regression between plasma total tau level change and self-reported daily alcohol intake change, adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma total tau level at baseline
Associations in linear regression, adjusted on age and sex, of plasma total tau level with: * age and sex, * morning alcohol withdrawal symptoms, self-reported at baseline, * cocaine or psychostimulant use disorder with active use in the previous month, self-reported at baseline * OAT * precarity score on questionnaire "EPICES", at baseline * homeless status, having slept on the street at least once in the last month, self-reported at baseline * MoCA score, at baseline * subscale score for "impulsivity" on Difficulties in Emotion Regulation Scale (DERS), at baseline * score on Obsessive Compulsive Drinking Scale (OCDS) at baseline Univariate analyses then multivariate analysis (if p-value \<.10 in univariate)
Time frame: Baseline
Proteome analysis
Changes in plasma proteome between the two arms (time x treatment interaction in a repeated measures ANOVAs), ITT adjusted on sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in alcohol craving between the two arms
Change in Obsessive Compulsive Drinking Scale score between the two arms (time x treatment interaction in a repeated measures ANOVA), in ITT adjusted for sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma NFL change and alcohol craving change
The association test in linear regression between plasma NFL level change and self-reported OCDS change, adjusted on sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma GFAP change and alcohol craving change
The association test in linear regression between plasma GFAP level change and self-reported OCDS change, adjusted on sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma total tau change and alcohol craving change
The association test in linear regression between plasma total tau level change and self-reported OCDS change, adjusted on sex and age.
Time frame: baseline (day 0) and follow-up (on days 14, 15, or 16)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2026 (actual). Primary completion is estimated for Oct 2027, 11 months after the start.
Of 122 non-industry phase 2 interventional studies under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 11 months is below that.
Counting every sponsor, half of 134 studies reached it within 33 months; a quarter within 21 and three quarters within 59.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Thiamine
Institut National de la Santé Et de la Recherche Médicale, France →