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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT03326128
Eligibility Criteria:
Inclusion Criteria:
* Smokes cigarettes daily for at least 1 year
* Breath CO of 5 ppm or higher at Baseline visit
* Age 21 - 65
Exclusion Criteria:
* Possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)
* Unstable cardiovascular disorder or uncontrolled hypertension
* Severe renal/hepatic impairment based on serology evaluation
* History of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury
* Current use of other cessation medication or counseling
* History of bupropion use
* Current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, CYP2B6 inhibitors, CYP2B6 inducers, drug metabolized by CYP2D6
* Sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
* Current (past 30 days) use of illicit or medical use of prescription stimulants
* Currently or plan to be pregnant or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03326128
Study Brief:
Protocol Section:
NCT03326128