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Corticosteroid

Dexamethasone for Alcohol Use Disorder

Phase < 1
Recruiting
Led By Helen C Fox, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range 18-55
Non-treatment seeking heavy drinking men and women with AUD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to +5 minutes following stress exposure
Awards & highlights

Study Summary

This trial is testing whether dexamethasone, a drug that reduces stress hormones, can help heavy drinkers with alcohol use disorder by decreasing their craving for alcohol during stressful situations.

Who is the study for?
This trial is for non-treatment seeking men and women aged 18-55 with alcohol use disorder (AUD) who are heavy drinkers. Participants must have a BMI of 18-35, test positive for alcohol in their system, be in good health, and able to understand English. Pregnant or breastfeeding individuals, those on certain medications like steroids or sedatives, and people with significant medical conditions cannot join.Check my eligibility
What is being tested?
The study tests if Dexamethasone (1.5mg), compared to a placebo, can reduce alcohol craving during stress by affecting cortisol levels and immune response. It's a double-blind study involving 70 participants split evenly by gender who will not know if they're receiving the real medication or a placebo.See study design
What are the potential side effects?
Dexamethasone may cause side effects such as mood swings, increased blood sugar levels, trouble sleeping, indigestion, possible increased risk of infection due to its impact on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.
Select...
I am a heavy drinker with alcohol use disorder and not seeking treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to +5 minutes following stress exposure
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to +5 minutes following stress exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol craving as assessed using subjective report following stress exposure
HPA axis response to stress exposure as assessed by ACTH
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
+3 more
Secondary outcome measures
Anxiety as assessed using subjective report following stress exposure
Negative Mood as assessed using subjective report following stress exposure

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GuanfacineActive Control1 Intervention
single dose of dexamethasone (1.5mg) administered orally
Group II: PlaceboPlacebo Group1 Intervention
single dose of placebo administered orally

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
215 Previous Clinical Trials
39,857 Total Patients Enrolled
1 Trials studying Alcoholism
60 Patients Enrolled for Alcoholism
Helen C Fox, PhDPrincipal InvestigatorStony Brook Renaissance School of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Alcoholism
60 Patients Enrolled for Alcoholism

Media Library

Dexamethasone Oral (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05305404 — Phase < 1
Alcoholism Research Study Groups: Placebo, Guanfacine
Alcoholism Clinical Trial 2023: Dexamethasone Oral Highlights & Side Effects. Trial Name: NCT05305404 — Phase < 1
Dexamethasone Oral (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305404 — Phase < 1
Alcoholism Patient Testimony for trial: Trial Name: NCT05305404 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the qualifying condition still being recruited for this experiment?

"According to the latest update on clinicaltrials.gov, this study is still looking for participants. The trial was first posted on March 11th, 2022 and was updated on July 25th, 2022."

Answered by AI

How many people are interested in participating in this research?

"That is correct. The clinical trial was originally posted on March 11th, 2022 and is actively recruiting patients. The study requires 70 participants and is only being conducted at a single site."

Answered by AI

Does your research include test subjects that are elderly?

"This specific trial only allows for patients who are 18 to 55 years old. However, there are 33 other studies available for those under 18 and 245 different trials for patients 65 and older."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Have never tried any treatments, but am ready to start.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
Helen Fox, PhD 2022. "Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05305404.
~5 spots leftby Jun 2024
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