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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05988632
Eligibility Criteria:
Inclusion Criteria:
* ≥21 years
* meet any DSM-5 criteria score for AUD
* Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g/dl, \~two drinks in one occasion)
* BrAC=0.00g/dL at each visit
* good health as confirmed by medical history, physical examination and lab tests
* willing to adhere to the study procedures
* understand informed consent and questionnaires in English at an 8th grade level
* willing to have glucose monitored by finger stick during the laboratory procedures
Exclusion Criteria:
* • female identifying who are breastfeeding or pregnant (assessed by a urine screen)
* individuals with diabetes
* history of suicide attempts in the last three years
* current diagnosis of other substance use disorder (other than nicotine or cannabis)
* use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen)
* cannabis intoxication (by clinical assessments)
* use of medications that may interact with insulin and alcohol (by Micromedex database)
* hypersensitivity to insulin
* any nasal disease/congestion that may interfere with intranasal drug absorption;
* baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose \>200mg/dL) (by finger stick)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05988632
Study Brief:
Protocol Section:
NCT05988632