MedTrace Logo

Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

NCT05305404 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-07-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Helen C Fox, PhD · Stony Brook Renaissance School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-06-23
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305404 on ClinicalTrials.gov