Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-28 @ 5:41 AM
Study NCT ID:
NCT05305404
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
Sponsor:
Stony Brook University
Organization:
Study Overview
Official Title:
Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: