Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Stony Brook University

Status and phase: Enrolling; Early Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Placebo; Drug: Dexamethasone Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT05305404

R21AA029735

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Guanfacine

Active Comparator group

Description:

single dose of dexamethasone (1.5mg) administered orally

Treatment:

Drug: Dexamethasone Oral

Placebo

Placebo Comparator group

Description:

single dose of placebo administered orally

Treatment:

Drug: Placebo