Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Alcohol Use Disorder Clinical Trial

Official title:

Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305404
• Other study ID #: R21AA029735
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 11, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: Stony Brook University
• Contact: Helen C Fox, PhD
• Phone: 631 638 0057
• Email: helen.fox[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Dexamethasone Oral
1.5mg oral dexamethasone to be administered once at 11:00PM
• Placebo
oral placebo to be administered once at 11:00PM

Locations

Country	Name	City	State
United States	The Health Sciences Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol craving as assessed using subjective report following stress exposure	The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving	Change from baseline to +5 minutes following stress exposure
Primary	Alcohol craving as assessed using subjective report following stress exposure	The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving	Change from baseline to +15 minutes following stress exposure
Primary	Alcohol craving as assessed using subjective report following stress exposure	The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving	Change from baseline to +30 minutes following stress exposure
Primary	Alcohol craving as assessed using subjective report 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)	Change from baseline to +5 minutes following stress exposure
Primary	Alcohol craving as assessed using subjective report 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)	Change from baseline to +15 minutes following stress exposure
Primary	Alcohol craving as assessed using subjective report 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)	Change from baseline to +30 minutes following stress exposure
Primary	Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol	4mls of plasma cortisol will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	HPA axis response to stress exposure as assessed by cortisol	4mls of plasma cortisol will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	HPA axis response to stress exposure as assessed by cortisol	4mls of plasma cortisol will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)	4mls of plasma ACTH will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	HPA axis response to stress exposure as assessed by ACTH	4mls of plasma ACTH will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	HPA axis response to stress exposure as assessed by ACTH	4mls of plasma ACTH will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL-10 will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL-10 will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL1-ra will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL1-ra will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL-6 will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL-6 will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma IL-6 will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma TNFa will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma TNFa will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress	Change from baseline to +5 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma TNFR1 will be collected following exposure to stress	Change from baseline to +15 minutes following stress exposure
Primary	Immune system response to stress exposure as assessed by peripheral cytokines	4mls of plasma TNFR1 will be collected following exposure to stress	Change from baseline to +30 minutes following stress exposure
Secondary	Anxiety as assessed using subjective report 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)	Change from baseline to +5 minutes following stress exposure
Secondary	Anxiety as assessed using subjective report 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)	Change from baseline to +15 minutes following stress exposure
Secondary	Anxiety as assessed using subjective report 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)	Change from baseline to +30 minutes following stress exposure
Secondary	Negative Mood as assessed using subjective report 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	Change from baseline to +5 minutes following stress exposure
Secondary	Negative Mood as assessed using subjective report 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	Change from baseline to +15 minutes following stress exposure
Secondary	Negative Mood as assessed using subjective report 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	Change from baseline to +30 minutes following stress exposure