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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
1.5mg oral dexamethasone to be administered once at 11:00PM
oral placebo to be administered once at 11:00PM
The Health Sciences Center
Stony Brook, New York, United States
RECRUITINGAlcohol 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
Time frame: Change from baseline to +5 minutes following stress exposure
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
Time frame: Change from baseline to +15 minutes following stress exposure
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
Time frame: Change from baseline to +30 minutes following stress exposure
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)
Time frame: Change from baseline to +5 minutes following stress exposure
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)
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Time frame: Change from baseline to +15 minutes following stress exposure
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)
Time frame: Change from baseline to +30 minutes following stress exposure
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Time frame: Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
4mls of plasma ACTH will be collected following exposure to stress
Time frame: Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Time frame: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
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
Time frame: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Time frame: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
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
Time frame: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
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
Time frame: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress
Time frame: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress
Time frame: Change from baseline to +30 minutes following stress exposure
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)
Time frame: Change from baseline to +5 minutes following stress exposure
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)
Time frame: Change from baseline to +15 minutes following stress exposure
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)
Time frame: Change from baseline to +30 minutes following stress exposure
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
Time frame: Change from baseline to +5 minutes following stress exposure
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
Time frame: Change from baseline to +15 minutes following stress exposure
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
Time frame: Change from baseline to +30 minutes following stress exposure