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Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder (STRENA)

3. november 2026 oppdatert av: Institut National de la Santé Et de la Recherche Médicale, France

Randomised Open-label Pilot Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder

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.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Rekruttering

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
60

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studiesteder

  • Frankrike
    • Île-de-France Region
      • Paris, Île-de-France Region, Frankrike, 75010
        • Rekruttering
        • Hospital Lariboisière Fernand-Widal
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Ingen inngripen: Styre
Eksperimentell: Thiamine

Thiamine 500mg twice daily for 14 days
Legemiddel: Thiamine

Thiamine 500mg twice daily for 14 days

Andre navn:
  • Bevitine

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in plasma NFL between the two arms, in ITT analysis
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in plasma NFL between the two arms, in PP analysis
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with reported alcohol use in the morning on plasma NFL change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in plasma GFAP level between the two arms
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in plasma total tau level between the two arms
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)

Andre resultatmål

Andre resultatmål

For kliniske studier, en planlagt måling beskrevet i protokollen som brukes for å bestemme effekten av en intervensjon/behandling på deltakerne. For observasjonsstudier, en måling eller observasjon som brukes til å beskrive mønstre av sykdommer eller egenskaper, eller assosiasjoner til eksponeringer, risikofaktorer eller behandling. Typer utfallsmål inkluderer primært resultatmål og sekundært resultatmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Interaction with self-reported daily alcohol intake on plasma NFL change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma NFL change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma NFL change and alcohol intake change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma NFL level change and self-reported daily alcohol intake change, adjusted for sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma NFL level at baseline
Tidsramme: 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)
Baseline
Adherence to thiamine treatment
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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)
baseline (day 0) and follow-up (on days 14, 15, or 16)
Montreal Cognitive Assessment (MoCA) at baseline
Tidsramme: 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)
Baseline
Change in plasma GFAP between the two arms, in PP analysis
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with reported alcohol use in the morning on plasma GFAP change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported daily alcohol intake on plasma GFAP change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma GFAP change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma GFAP change and alcohol intake change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma GFAP level change and self-reported daily alcohol intake change, adjusted for sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma GFAP level at baseline
Tidsramme: 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)
Baseline
Change in plasma total tau between the two arms, in PP analysis
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with self-reported daily alcohol intake on plasma total tau change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
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
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Interaction with opioid agonist therapy on plasma total tau change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma total tau change and alcohol intake change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma total tau level change and self-reported daily alcohol intake change, adjusted for sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Plasma total tau level at baseline
Tidsramme: 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)
Baseline
Proteome analysis
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

Changes in plasma proteome between the two arms (time x treatment interaction in a repeated measures ANOVAs), ITT adjusted on sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Change in alcohol craving between the two arms
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

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.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma NFL change and alcohol craving change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma NFL level change and self-reported OCDS change, adjusted on sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma GFAP change and alcohol craving change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma GFAP level change and self-reported OCDS change, adjusted on sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)
Association between plasma total tau change and alcohol craving change
Tidsramme: baseline (day 0) and follow-up (on days 14, 15, or 16)

The association test in linear regression between plasma total tau level change and self-reported OCDS change, adjusted on sex and age.
baseline (day 0) and follow-up (on days 14, 15, or 16)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
Institut National de la Santé Et de la Recherche Médicale, France

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Hovedetterforsker: Virgile Clergue-Duval, MD PhD, Assistance Publique - Hôpitaux de Paris
  • Studieleder: Florence Vorspan, MD PhD, Inserm UMR-S 1144 Therapeutic optimization in neuropharmacology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
2. november 2026

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
22. oktober 2027

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
22. oktober 2027

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
15. september 2026

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
22. september 2026

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
28. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
3. november 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • C25-96
  • 2025 (U.S. NIH-stipend/kontrakt)
  • 2025-524148-36-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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