A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers.
Study Goal
The researchers aimed to evaluate the pharmacokinetic profiles and subjective effects of nicotine from e-cigarettes containing nicotine salts compared to conventional cigarettes.
Results Summary
The study found that nicotine absorption from e-cigarettes was as rapid as conventional cigarettes but did not exceed it. Subjective satisfaction was highest for conventional cigarettes, followed by a 40-mg nicotine salt formulation, and all e-cigarettes modestly reduced the desire to smoke.
Population
15 healthy US adult smokers.
Effective Dosage
40-mg nicotine salt formulation (specific frequency not mentioned).
Duration
Consecutive days (exact duration not specified).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
e-cigarettes containing 'nicotine salts' | increase | smoker's satisfaction | - | - | aim to increase | #1 |
e-cigarettes containing 'nicotine salts' | increase | blood nicotine delivery and other sensory properties | - | - | improving | #2 |
two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid | neutral | pharmacokinetic profiles and subjective effects of nicotine | 15 healthy US adult smokers | - | evaluated | #3 |
all e-cigarettes tested | no change | rate of nicotine absorption into the bloodstream | 15 healthy US adult smokers | - | rate of nicotine absorption was comparable | #4 |
all e-cigarettes tested | no change | rate of nicotine absorption | 15 healthy US adult smokers | - | was as rapid as | #5 |
all e-cigarettes tested | no change | nicotine delivery | 15 healthy US adult smokers | - | nicotine delivery did not exceed | #6 |
nicotine salt emissions | neutral | pharmacokinetic profiles | 15 healthy US adult smokers | - | pharmacokinetic profiles were dependent upon | #7 |
conventional cigarette | increase | subjective scores | 15 healthy US adult smokers | - | subjective scores were numerically highest after | #8 |
myblu 40-mg nicotine salt formulation | increase | subjective scores | 15 healthy US adult smokers | - | subjective scores were numerically highest after | #9 |
all the tested e-cigarettes | decrease | relieving the desire to smoke | 15 healthy US adult smokers | 'a little' to 'modestly' | rise in nicotine blood levels was quantified as 'a little' to 'modestly' satisfying | #10 |
all products | neutral | tolerability | 15 healthy US adult smokers | - | were well tolerated | #11 |
use of nicotine salts in e-cigarettes | decrease | nicotine delivery | - | - | delivering less nicotine than a conventional cigarette | #12 |
use of nicotine salts in e-cigarettes | increase | pulmonary delivery of nicotine | - | - | enables cigarette-like pulmonary delivery of nicotine | #13 |
use of nicotine salts in e-cigarettes | decrease | desire to smoke | - | - | reduces | #14 |
E-cigarettes containing 'nicotine salts' aim to increase smoker's satisfaction by improving blood nicotine delivery and other sensory properties. Here, we evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. A randomised, open-label, cross-over clinical study was conducted in 15 healthy US adult smokers. Five different e-cigarette products were evaluated consecutively on different days after use of own brand conventional cigarette. Plasma nicotine pharmacokinetics, subjective effects, and tolerability were assessed following controlled use of the products. The rate of nicotine absorption into the bloodstream was comparable from all e-cigarettes tested and was as rapid as that for conventional cigarette. However, in all cases, nicotine delivery did not exceed that of the conventional cigarette. The pharmacokinetic profiles of nicotine salt emissions were also dependent upon the properties of the e-cigarette device. Subjective scores were numerically highest after smoking a conventional cigarette followed by the myblu 40-mg nicotine salt formulation. The rise in nicotine blood levels following use of all the tested e-cigarettes was quantified as 'a little' to 'modestly' satisfying at relieving the desire to smoke. All products were well tolerated with no notable adverse events reported. These results demonstrate that, while delivering less nicotine than a conventional cigarette, the use of nicotine salts in e-cigarettes enables cigarette-like pulmonary delivery of nicotine that reduces desire to smoke.