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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03281694
Eligibility Criteria:
Inclusion Criteria:
* Aged 21-50 years.
* Male or female willing to use qualified methods of contraception for the study duration and up to 2 months after its end. Qualified methods are: intrauterine device, condoms, oral contraceptives, surgical sterilization of the subject or the partner at least one year in advance, or postmenopausal status of the female defined as at least two years without menstruation.
* No exposure to any nicotine-containing product in the last year.
* Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime.
* Normal or corrected to normal vision (at least 20/80).
* Body weight 110-220 lbs.
Exclusion Criteria:
* Pregnant or breast-feeding.
* DSM Axis I mood, anxiety or psychotic disorder.
* Drug or alcohol abuse or dependence currently or in the last 2 years.
* Cardiovascular or cerebrovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities (see below).
* Uncontrolled hypertension (resting systolic BP \>150 or diastolic \>95 mm Hg).
* Hypotension (resting systolic BP below 90 or diastolic below 60).
* Significant kidney or liver impairment.
* Moderate to severe asthma.
* Type I diabetes.
* Gastrointestinal illness.
* Use of any prescription or over-the-counter medication except birth control or non-steroidal antiinflammatory drugs on an as-needed basis.
* History of or current neurological illnesses, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
* Learning disability, mental retardation, or any other condition that impedes cognition.
* Any surgeries requiring full anesthesia scheduled within 2 weeks of any of the study test sessions.
* Inability to perform the Rapid Visual Information Processing Task.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT03281694
Study Brief:
Protocol Section:
NCT03281694