💬In plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration
* no self-reported nicotine/tobacco uses in the past 30 days
* urine cotinine less than 100 ng/ml at screening.
Exclusion criteria (all participants):
* psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
* current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety
* currently have severe dependence for cannabis
* history of or current significant medical condition that, in the opinion of medical staff, will impact safety
* current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety
* women who are pregnant, planning to become pregnant, or are breast-feeding
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