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Dexamethason zur Bekämpfung von Stress und Mechanismen des Immunsystems, die dem Verlangen nach Alkohol zugrunde liegen

28. September 2026 aktualisiert von: Helen Fox, Stony Brook University

Dexamethason zur Bekämpfung von Stress und Veränderungen des Immunsystems während der frühen Abstinenz bei Personen mit Alkoholkonsumstörung (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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

27

Phase

  • Frühphase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • Stony Brook, New York, Vereinigte Staaten, 11794
        • The Health Sciences Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Guanfacine

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

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

Andere Namen:
  • Decadron, Dexamethason Intensol, Dexasone, Solurex und Baycadron.
Placebo-Komparator: Placebo

single dose of placebo administered orally
Arzneimittel: Placebo

oral placebo to be administered once at 11:00PM

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Alcohol craving as assessed using subjective report following stress exposure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety as assessed using subjective report following stress exposure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stony Brook University

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. März 2022

Primärer Abschluss (Tatsächlich)

23. Juni 2024

Studienabschluss (Tatsächlich)

30. Juni 2024

Studienanmeldedaten

Zuerst eingereicht

22. März 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. März 2022

Zuerst gepostet (Tatsächlich)

31. März 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R21AA029735 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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