Clinical trial NCT05305404: Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
Official title: Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Keywords: Stress
Dexamethasone
Immune system
Cortisol
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Alcohol craving as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: HPA axis response to stress exposure as assessed by cortisol
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: HPA axis response to stress exposure as assessed by cortisol
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: HPA axis response to stress exposure as assessed by ACTH
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: HPA axis response to stress exposure as assessed by ACTH
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Immune system response to stress exposure as assessed by peripheral cytokines
timeFrame: Change from baseline to +30 minutes following stress exposure
Secondary outcomes:
measure: Anxiety as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Anxiety as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Anxiety as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +30 minutes following stress exposure
measure: Negative Mood as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +5 minutes following stress exposure
measure: Negative Mood as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +15 minutes following stress exposure
measure: Negative Mood as assessed using subjective report following stress exposure
timeFrame: Change from baseline to +30 minutes following stress exposure
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: The Health Sciences Center
state: New York
Study officials:
affiliation: Stony Brook Renaissance School of Medicine
name: Helen C Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: