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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.

Internal and emergency medicine
September 1, 2019
Grant O'Connell et al. (7 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

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.

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
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
Abstract

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.

Medical Subject Headings (MeSH)
AdultCross-Over StudiesElectronic Nicotine Delivery SystemsFemaleHumansMaleMiddle AgedNicotinePharmacokineticsNicotiana
Study Links
Quality Scores
Safety85
Efficacy70/10
Quality75/10
Citation Metrics
Total Citations78
Citations/Year13.0
Relative Citation Ratio5.72
NIH Percentile94.4%
Research Impact Scores
APT Score0.75
Weight Score2.41
Normalized Score0.77
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