Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05305404
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05305404
Study Brief:
Protocol Section:
NCT05305404