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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine | Active Comparator | single dose of dexamethasone (1.5mg) administered orally |
|
| Placebo | Placebo Comparator | single dose of placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Oral | Drug | 1.5mg oral dexamethasone to be administered once at 11:00PM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen C Fox, PhD | Contact | 631 638 0057 | helen.fox@stonybrookmedicine.edu | |
| Erin C Vacey | Contact | 631 638 1545 | erin.vacey@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Helen C Fox, PhD | Stony Brook Renaissance School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Health Sciences Center | Recruiting | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
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Study is double blind, where participants and investigators are blind to the medication assignment
| Placebo | Drug | oral placebo to be administered once at 11:00PM |
|
| 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | Change from baseline to +30 minutes following stress exposure |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |