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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05656534
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65.
* Participant is able to give informed consent.
* Generally medically and physically healthy as confirmed by medical history.
* Meet DSM-5 diagnostic criteria for current moderate or severe AUD.
* Engage in heavy alcohol use defined as drinking equal or greater than 14 standard drinks per week if male and equal or greater than 7 standard drinks per week if female.
Exclusion Criteria:
* Clinically significant medical or neurological condition (e.g., liver disease, narcolepsy, complex sleep behaviors, severe hepatic impairment, COPD, severe obstructive sleep apnea).
* Current cognitive dysfunction (traumatic brain injury, mental retardation, organic mental syndrome, pervasive developmental disorder, or dementia).
* Current use of antihistamines, strong or moderate inhibitors of CYP3A liver enzymes, strong CYP3A inducers, or digoxin.
* Current or past DSM-5 diagnosis of mania, schizophrenia, psychosis, suicidality, major depressive disorder, or obsessive compulsive disorder.
* Current substance use disorder other than alcohol or mild cannabis use disorder.
* Treatment seeking for AUD.
* Recent psychotropic medication use in the past 2 months.
* Currently smokes 5 or more cigarettes (or electronic equivalent) per day.
* BMI equal or greater than 35.
* Engage in night-shift work.
* Lack of fluency in English.
* Presence of ferrous-containing metal in the body.
* Inability to tolerate small, enclosed spaces.
* Deafness in one or both ears.
* Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05656534
Study Brief:
Protocol Section:
NCT05656534