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 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT04078035
Eligibility Criteria:
Inclusion Criteria:
* Generally healthy
* Non-smokers/illicit drug users
* Blood pressure below 140/90
* Weight \> 110 lbs
* BMI \< 30
* Fluent in English
* Women -- regular menstrual cycles over the past 12 months (defined as 21- 35 days in length)
* Able and willing to give informed consent
* Willing to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days before testing.
* Willing to attend two laboratory stress testing sessions, give blood though an intravenous catheter, undergo medical evaluation and complete psychosocial questionnaires.
Exclusion Criteria:
* Reported history of chronic systemic immune, metabolic or mitochondrial diseases, or chronic diseases that influence the central nervous, autonomic nervous or neuroendocrine systems, e.g., autoimmune disease, chronic infections, cardiovascular disease, diabetes, chronic kidney or liver disease, cancer treatment.
* Reported psychiatric history of schizophrenia or other psychotic illness, or mood disorder.
* Resting blood pressure \> 140/90 mmHg at baseline testing.
* Weight \< 110 lbs
* BMI equal to or greater than 30
* Report currently taking glucocorticoid, anti-inflammatory, anti-retroviral, immunosuppressant, insulin, antiarrhythmic, antihypertensive, oral hypoglycemic, antidepressant, benzodiazepine or prescription weight loss medications or other medications known to influence the immune, autonomic or neuroendocrine systems.
* For women - Post-menopausal or irregular menstrual cycles over the past 12 months. Report current pregnancy or lactation.
* Current smokers (defined as having smoked a cigarette in the previous 3 months).
* Current illicit drug use (defined as reported use of illicit drugs such as marijuana, cocaine or heroin in the previous 3 months).
* Not fluent in English (have used English in everyday speaking and reading for at least 10 years)
* Unable or unwilling to give informed consent
* Unwilling to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days prior to testing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT04078035
Study Brief:
Protocol Section:
NCT04078035