The Acute Effects of Oral Nicotine Pouches Among Infrequent and Frequent Nicotine/Tobacco Users
Johns Hopkins University
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).
Description
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 2 outpatient experimental sessions (separated by at least 48 hours). The study will use a mixed between/within-subjects crossover design. The between-subjects component is because there are two groups of participants (60 cigarette smokers, 60 infrequent nicotine users) and the within-subjects component is because participants complete all experimental sessions (thus, serving as the participant's own control). Smokers…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
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 inclu…
Interventions
- DrugNicotine Pouches
Nicotine pouches
Location
- Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)Baltimore, Maryland