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Dexamethason om stress- en immuunsysteemmechanismen aan te pakken die ten grondslag liggen aan het verlangen naar alcohol

28 september 2026 bijgewerkt door: Helen Fox, Stony Brook University

Dexamethason om stress en veranderingen in het immuunsysteem aan te pakken tijdens vroege onthouding bij personen met een alcoholgebruiksstoornis (AUD)

This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

27

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • Stony Brook, New York, Verenigde Staten, 11794
        • The Health Sciences Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Non-treatment seeking heavy drinking men and women with AUD
  • Age range 18-55,
  • Body Mass Index (BMI) of 18-35
  • Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
  • Able to provide informed written and verbal consent
  • Able to read English and complete study evaluations
  • Good health as verified by screening examination.

Exclusion Criteria:

  • Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
  • Unable to remain abstinent for five days
  • Need for a medically assisted detoxification
  • Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
  • Psychotic or severely psychiatrically disabled
  • Significant underlying medical conditions which would be of potential harm
  • Pregnancy or breast feeding women;
  • Women using monophasic contraceptives
  • Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Guanfacine

single dose of dexamethasone (1.5mg) administered orally
Geneesmiddel: Dexamethasone Oral

1.5mg oral dexamethasone to be administered once at 11:00PM

Andere namen:
  • Decadron, Dexamethason Intensol, Dexasone, Solurex en Baycadron.
Placebo-vergelijker: Placebo

single dose of placebo administered orally
Geneesmiddel: Placebo

oral placebo to be administered once at 11:00PM

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Change from baseline to +30 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +30 minutes following stress exposure
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma cortisol will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma ACTH will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL-10 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL-10 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL1-ra will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL1-ra will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma IL-6 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma TNFa will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma TNFa will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

4mls of plasma TNFR1 will be collected following exposure to stress
Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

4mls of plasma TNFR1 will be collected following exposure to stress
Change from baseline to +30 minutes following stress exposure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anxiety as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +5 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +15 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Change from baseline to +30 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +5 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +5 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +15 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +15 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Tijdsspanne: Change from baseline to +30 minutes following stress exposure

The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Change from baseline to +30 minutes following stress exposure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Stony Brook University

Onderzoekers

  • Hoofdonderzoeker: Helen C Fox, PhD, Indiana University School of Medicine, Dept. of Psychiatry

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 maart 2022

Primaire voltooiing (Werkelijk)

23 juni 2024

Studie voltooiing (Werkelijk)

30 juni 2024

Studieregistratiedata

Eerst ingediend

22 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

22 maart 2022

Eerst geplaatst (Werkelijk)

31 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R21AA029735 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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