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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT01480232
Eligibility Criteria:
Inclusion Criteria:
* Self-report of smoking an average of ≥10 cigarettes/day for 6 months and expired carbon monoxide (CO) ≥10 parts per million (ppm) or urine cotinine ≥ 100 ng/mL at screening or self-report of smoking an average of 5-9 cigarettes/day for 6 months and a urine cotinine ≥30ng/ml at screening
* Have a negative urine drug screen at screening
* Fertile, sexually active subjects (males and females) must use an effective method of contraception from the first dose of study drug and for 3 months after the last dose of study drug
* If female and capable of conception, must have a negative urine Human chorionic gonadotrophin (hCG) pregnancy test at screening and Day 1
Exclusion Criteria:
* Have unstable medical illness with hospitalization for treatment likely within 6 months
* Have life-threatening arrhythmia, cerebrovascular or cardiovascular event within 6 months of enrollment
* Have liver function tests elevated \>2.5 times the upper limit of normal range
* Have a tumor or a seizure disorder
* Currently using other tobacco- or nicotine-containing products and unwilling to try to quit
* Have a 6-month history of substance use disorder other than nicotine or caffeine or major depressive disorder
* Have a history of multiple adverse drug reactions
* Non-response (past 3 months) to nicotine replacement therapy (NRT) \>20 mg/day, bupropion \>150 mg/day, or varenicline 2 mg/day for ≥4 weeks
* Use of excluded concomitant medications
* Hospitalization for any reason within 30 days of screening
* Use of any investigational drug or device within 30 days of screening
* Have clinically significant abnormal serum electrolytes
* Have insufficiently controlled diabetes mellitus
* Have renal insufficiency (serum creatinine \>1.8 mg/dL)
* Malignant tumor within the last 5 years, with the exception of squamous and basal cell carcinoma or cervical carcinoma in situ
* Have a clinically significant cardiovascular abnormality on the screening EKG
* Lifetime history of schizophrenia, bipolar disorder, post-traumatic stress disorder, bulimia, organic mental disorder, dementia, pervasive developmental disorder
* Have untreated, clinically significant hypothyroidism or hyperthyroidism
* Have a positive self-report of human immunodeficiency virus infection
* Females who are pregnant or nursing
* Any experimental drug currently or within 30 days before baseline
* Have a serious risk of suicide
* Have a screening electrocardiogram (ECG) with a corrected QT (QTc) interval using Bazett's formula \>450 msec for males and \>470 msec for females or the presence of any clinically significant cardiac abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01480232
Study Brief:
Protocol Section:
NCT01480232