Status:
UNKNOWN
Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
Lead Sponsor:
Stony Brook University
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
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 hypot...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05305404
Start Date
March 11 2022
End Date
June 30 2024
Last Update
July 28 2022
Active Locations (1)
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1
The Health Sciences Center
Stony Brook, New York, United States, 11794