Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Desametasone per indirizzare lo stress e i meccanismi del sistema immunitario alla base del desiderio di alcol

28 settembre 2026 aggiornato da: Helen Fox, Stony Brook University

Desametasone per colpire lo stress e i cambiamenti del sistema immunitario durante l'astinenza precoce in individui con disturbo da uso di alcol (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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

27

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • Stony Brook, New York, Stati Uniti, 11794
        • The Health Sciences Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Guanfacine

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

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

Altri nomi:
  • Decadron, Desametasone Intensol, Dexasone, Solurex e Baycadron.
Comparatore placebo: Placebo

single dose of placebo administered orally
Droga: Placebo

oral placebo to be administered once at 11:00PM

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Alcohol craving as assessed using subjective report following stress exposure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety as assessed using subjective report following stress exposure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Stony Brook University

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 marzo 2022

Completamento primario (Effettivo)

23 giugno 2024

Completamento dello studio (Effettivo)

30 giugno 2024

Date di iscrizione allo studio

Primo inviato

22 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

22 marzo 2022

Primo Inserito (Effettivo)

31 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R21AA029735 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi