Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Status unconfirmed · Early Phase 1 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT05305404

Run by

Stony Brook University

People needed

70

Starts

2022-03-11

Expected to finish

2024-06-30

Last updated by the study team

2022-07-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The Health Sciences Center — Stony Brook, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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