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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT03021616
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female, active duty military service members or DoD beneficiaries, who are eligible to receive care at DGMC.
* Ages 18-40 years old.
* Participants must be willing to refrain from caffeine and energy drink use 48 hours prior to study days 1, 8, and 15
Exclusion Criteria:
* In an effort to recruit subjects in general good health, those with the following medical conditions or disease states will be excluded from enrollment:
* Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, palpitations, T-wave abnormalities, baseline corrected QT (QTc) interval greater than 440 milliseconds(ms). This will be determined on the ECG obtained during initial screening appointment, and reviewed by cardiologist and through the questionnaire responses of the participant.
* Blood pressure at initial screening appointment or at baseline on study Day 1 greater than 140/90
* Hypokalemia or liver abnormalities (AST/ALT abnormality) identified at initial appointment when baseline lab values will be drawn.
* Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
* Hypertension
* Thyroid disease
* Type 1 or 2 diabetes mellitus
* Recurrent headaches
* Depression, currently receiving treatment (due to possible drug interactions)
* Any psychiatric condition or neurological disorder including seizures
* History of alcohol or drug abuse in the previous 5 years
* Ever been diagnosed or told they have or had renal or hepatic dysfunction
* Concurrent use of ANY medication taken in an amount greater than twice a week, to include herbal products or supplements, NOT TO INCLUDE hormonal contraceptives. If less than or equal to 2 days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
* Pregnant or lactating females will be excluded from participation with urine dipstick tests used to confirm pregnancy (pregnancy test performed before each treatment session, days 1, 8 and 15)
* All non-English speaking / writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
* If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.
* Allergy to any substance in the study design.
* Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03021616
Study Brief:
Protocol Section:
NCT03021616