Status
Conditions
Treatments
About
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.
Full description
This will be a single-center, randomized, open-label, parallel study during which up to 140 healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of four (4) marketed EC products in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Able to read, understand, and willing to sign an ICF and complete questionnaires written in English.
Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit.
Subjects must meet one (a or b) of the following tobacco use conditions:
i. Smoking at least (≥) 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and ii. Using a nicotine-containing cig-a-like EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.
Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
Willing to use assigned IP during the study according to protocol.
Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the Screening Visit and Study Day 1.
Positive urine cotinine test at the Screening Visit and Study Day 1.
No intent to quit smoking or vaping from the Screening Visit to Study Day 2.
Females must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
122 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal