Trial Parameters
Brief Summary
The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions. The investigators are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).
Eligibility Criteria
Inclusion criteria (all participants): * greater than or equal to 21 years old * good general health based on screening procedures * vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg) * negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session * no self-reported prior use of oral nicotine pouches * Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy) Additional inclusion criteria (smokers): * self-report currently smoking cigarettes daily * exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening * meet criteria for tobacco use disorder * no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days Additional inclusion criteria (non-nicotine users): * self-repo