Alcohol Use Disorder
Conditions
Keywords
Stress, Dexamethasone, Immune system, Cortisol
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.
Interventions
DRUGPlacebo
oral placebo to be administered once at 11:00PM
DRUGDexamethasone Oral
1.5mg oral dexamethasone to be administered once at 11:00PM
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Study is double blind, where participants and investigators are blind to the medication assignment
Intervention model description
This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune system response to stress exposure as assessed by peripheral cytokines | Change from baseline to +5 minutes following stress exposure | 4mls of plasma Interleukin (IL)-10 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 +15 minutes following stress exposure | 4mls of plasma ACTH will be collected following exposure to stress |
| Alcohol craving as assessed using subjective report following stress exposure | Change from baseline to +5 minutes 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 |
| 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 +15 minutes following stress exposure | 4mls of plasma cortisol will be collected following exposure to stress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Mood as assessed using subjective report following stress exposure | Change from baseline to +5 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 |
| Anxiety as assessed using subjective report following stress exposure | Change from baseline to +5 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) |
Countries
United States
Contacts
Primary ContactHelen C Fox, PhD
Backup ContactErin C Vacey
Outcome results
None listed