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Deksametason for å målrette mot stress og immunsystemmekanismer som ligger til grunn for alkoholtrang

28. september 2026 oppdatert av: Helen Fox, Stony Brook University

Deksametason for å målrette mot stress og endringer i immunsystemet under tidlig avholdenhet hos personer med alkoholmisbruk (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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

27

Fase

  • Tidlig fase 1

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • New York
      • Stony Brook, New York, Forente stater, 11794
        • The Health Sciences Center

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

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Guanfacine

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

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

Andre navn:
  • Decadron, Dexamethason Intensol, Dexasone, Solurex og Baycadron.
Placebo komparator: Placebo

single dose of placebo administered orally
Legemiddel: Placebo

oral placebo to be administered once at 11:00PM

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alcohol craving as assessed using subjective report following stress exposure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety as assessed using subjective report following stress exposure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

Stony Brook University

Etterforskere

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

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)

11. mars 2022

Primær fullføring (Faktiske)

23. juni 2024

Studiet fullført (Faktiske)

30. juni 2024

Datoer for studieregistrering

Først innsendt

22. mars 2022

Først innsendt som oppfylte QC-kriteriene

22. mars 2022

Først lagt ut (Faktiske)

31. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R21AA029735 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

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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