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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02754258
Eligibility Criteria:
Inclusion Criteria:
* males and females 16 to 40 years old
* BMI in the obese category (above 29.9kg/m2)
* willing to comply with procedures, and sign informed consent forms
* able to swallow a placebo pill that will be used in the study (same size as study drug)
Exclusion Criteria:
* smoker (the main outcome is energy intake and smoking is known to impact appetite)
* known serious food allergies, including lactose
* history of previous MPH use or allergy to MPH
* history of ADHD or current diagnosis of an axis 1 psychiatric disorder (e.g., depression, panic disorder, schizophrenia) as measured by self-report, the Wender-Utah Rating Scale52-54 and the Beck Depression Inventory
* current use of antidepressants, thyroid medication, or any medication that could affect appetite
* high blood pressure
* pre-existing cardiovascular disorders including uncontrolled hypertension, angina pectoris, arterial occlusive disease, heart failure, cardiomypathies, myocardial infarction, and cardiac arrhythmia
* diabetes
* excessive use of alcohol or alcoholism, or current addictions to opiates, cocaine or stimulants as measured by the Drug Abuse Screening Test;
* not a restrained eater based on cut-score (11 or higher) on Three Factor Eating Questionnaire56
* glaucoma
* personal or family history of seizure disorders
* currently taking MAO inhibitors, pressor agents, coumarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants
* history of thyroid disease
* personal or family history of motor tics or Tourettes's Syndrome
* not pregnant, as determined by commercially available pregnancy test taken by female participants prior to test dose of MPH.
* after the test dose of MPH, systolic blood pressure exceeding baseline reading by 20mmHg, diastolic blood pressure exceeding the baseline reading by 10mmHg, BP \> 160/100, or resting pulse increased by 20 beats/minute from the baseline.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT02754258
Study Brief:
Protocol Section:
NCT02754258