Study on Effects of Different Nicotine Types and Levels in E-Cigarettes for Adults Aged 21 to 65

What this Trial Is About

Researchers are studying how different characteristics of nicotine in e-cigarettes ECs affect addiction potential and health risks. The trial aims to understand how nicotine strength, form, and structure influence the way people use ECs, how the body processes nicotine, and any possible harmful effects. This information may help identify optimal nicotine levels for users and support development of product standards to promote public health. The study has two phases. In Phase 1, participants are randomized to vape one of eight e-liquids that differ by nicotine concentration 20 or 50 mgg, form, and isomer type. Each session includes a 10-puff vaping period over 5 minutes followed by a 60-minute free puffing session, with 8 lab visits total. Participants practice at home with devices matching the study e-liquids. In Phase 2, participants vape 20 different e-liquids varying in nicotine concentration, free-base nicotine percentage, and isomer type during two visits with multiple 2-puff sessions and washout periods between. Participants attend lab visits for vaping sessions, carbon monoxide testing, and blood and urine sample collection. The study measures nicotine blood levels, metabolism, toxicity, puffing behavior, and subjective responses using questionnaires. The trial monitors effects over up to 2 years. Total participation duration varies by phase. The study includes healthy adult EC users and smokers interested in trying ECs, assessing multiple factors to understand nicotines impact on use and health.

Manipulating E-Cigarette Nicotine to Promote Public Health