Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study is double blind, where participants and investigators are blind to the medication assignment

Study Groups

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Guanfacine

single dose of dexamethasone (1.5mg) administered orally

Group Type ACTIVE_COMPARATOR

Dexamethasone Oral

Intervention Type DRUG

1.5mg oral dexamethasone to be administered once at 11:00PM

Placebo

single dose of placebo administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral placebo to be administered once at 11:00PM

Interventions

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Dexamethasone Oral

1.5mg oral dexamethasone to be administered once at 11:00PM

Intervention Type DRUG

Placebo

oral placebo to be administered once at 11:00PM

Intervention Type DRUG

Other Intervention Names

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Decadron, Dexamethasone Intensol, Dexasone, Solurex, and Baycadron.

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No