Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Early Phase 1

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Dexamethasone Oral; Drug: Placebo

• Registration Number: NCT05305404
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-28
• Primary Completion: 2024-06-23
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guanfacine	Dexamethasone Oral	single dose of dexamethasone (1.5mg) administered orally
Placebo	Placebo	single dose of placebo administered orally

Primary Outcome Measures

Name	Time	Method
Alcohol craving as assessed using subjective report following stress exposure	Change from baseline to +30 minutes following stress exposure	A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol	Change from baseline to +5 minutes following stress exposure	4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by cortisol	Change from baseline to +30 minutes following stress exposure	4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)	Change from baseline to +5 minutes following stress exposure	4mls of plasma ACTH will be collected following exposure to stress
HPA axis response to stress exposure as assessed by ACTH	Change from baseline to +30 minutes following stress exposure	4mls of plasma ACTH will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines	Change from baseline to +30 minutes following stress exposure	4mls of plasma TNFR1 will be collected following exposure to stress

Secondary Outcome Measures

Name	Time	Method
Anxiety as assessed using subjective report following stress exposure	Change from baseline to +30 minutes following stress exposure	A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Negative Mood as assessed using subjective report following stress exposure	Change from baseline to +30 minutes following stress exposure	The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely

Trial Locations

Locations (1)

The Health Sciences Center; 🇺🇸 Stony Brook, New York, United States