Recruiting
Early Phase 1

Dexamethasone

Sponsor:

Stony Brook University

Code:

NCT05305404

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Dexamethasone Oral

Placebo

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder

Study ID

NCT05305404

Start date

Mar 11, 2022

Status verified date

Jul, 2022

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 23, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Guanfacine

single dose of dexamethasone (1.5mg) administered orally

placebo comparator: Placebo

single dose of placebo administered orally

Interventions

Dexamethasone Oral

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

Placebo

oral placebo to be administered once at 11:00PM

Primary outcome measure

  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Alcohol craving as assessed using subjective report following stress exposure [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • HPA axis response to stress exposure as assessed by cortisol [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • HPA axis response to stress exposure as assessed by cortisol [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH) [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • HPA axis response to stress exposure as assessed by ACTH [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • HPA axis response to stress exposure as assessed by ACTH [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +30 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +5 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +15 minutes following stress exposure ]
  • Immune system response to stress exposure as assessed by peripheral cytokines [ Time Frame: Change from baseline to +30 minutes following stress exposure ]

Central Contacts and Locations

Central contacts

Helen C Fox, PhD

631 638 0057helen.fox@stonybrookmedicine.edu

Erin C Vacey

631 638 1545erin.vacey@stonybrookmedicine.edu

Locations

The Health Sciences Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Helen Fox, PhD

631-638-0057helen.fox@stonybrookmedicine.edu

Erin Vacey

631 638 1545erin.vacey@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Jul 28, 2022

Last verified

Jul, 2022

Keywords

  • Stress
  • Dexamethasone
  • Immune system
  • Cortisol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2022-07-28.