NCT05305404

Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dexamethasone Oral	1.5mg oral dexamethasone to be administered once at 11:00PM
DRUG	Placebo	oral placebo to be administered once at 11:00PM

Timeline

• Start date: 2022-03-11
• Primary completion: 2024-06-23
• Completion: 2024-06-30
• First posted: 2022-03-31
• Last updated: 2022-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study