Phase 1 Study Comparing Effects of Nicotine and Related Compounds in Adult Electronic Cigarette Users

What this Trial Is About

Researchers are studying the preferences and smoking behaviors of electronic cigarette EC users when using nicotine analogs compared to nicotine. This phase I trial aims to better understand the addictiveness of nicotine analogs, which are compounds chemically similar to nicotine found in some EC products. The study also evaluates the acute effects of these substances on cardiovascular health, including blood pressure and heart rate, as vaping ECs can influence these factors and potentially pose risks. Participants are assigned to one of six sequences involving three study visits. During each visit, participants take one puff of the assigned EC nicotine, 6-methyl nicotine 6-MN, or nicotinamide every 30 seconds for 5 minutes, totaling 10 puffs, if no unacceptable side effects occur. After a 60-minute break, they may use the EC as much as they like for an hour. This process is repeated for each of the three substances across the visits. Urine samples are collected during screening, and blood samples are taken during the study. A subset of current EC users also undergo cardiovascular and endothelial function tests. Participants are followed up at 4 and 12 weeks after completing the study interventions. Throughout the trial, researchers measure nicotine cravings, withdrawal symptoms, economic demand for EC use, puffing behaviors, pharmacokinetics, heart rate, cardiovascular responses, and endothelial function at specific time points during and after puffing sessions. This detailed monitoring helps understand both behavioral and physiological responses to nicotine analogs and nicotine itself.

Comparative Evaluation of Nicotine Analogs