At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes
In Brief
A clinical study evaluating Nicotine vaping visit 1 (free-base nicotine), Nicotine vaping visit 1 (protonated nicotine), and 2 other interventions for Nicotine Vaping. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The investigators will examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery. Participants will puff on electronic nicotine delivery system (ENDS) devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. The outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability.
Study Details
Timeline
Interventions
Participants will receive the free-base form of four nicotine fluxes: 9, 18, 27, 35 μg/sec at one of their two visits. Participants will use the ENDS device with free-base nicotine and four fluxes in random order.
Participants will receive the protonated form of four nicotine fluxes: 9, 18, 27, 35 μg/sec at the other study visit. Participants will use the ENDS device with protonated nicotine and four fluxes in random order.
Participants who received protonated nicotine during visit 1 will now receive free-base nicotine fluxes for visit 2: 9, 18, 27, 35 μg/sec.
Participants who received free-base nicotine during visit 1 will now receive protonated nicotine fluxes for visit 2: 9, 18, 27, 35 μg/sec.