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Assessment of the Nicotine Pharmacokinetics When Using Two Types of E-Cigarettes in Healthy Adults Who Smoke: Results From Two Randomized, Crossover Studies Cover

Assessment of the Nicotine Pharmacokinetics When Using Two Types of E-Cigarettes in Healthy Adults Who Smoke: Results From Two Randomized, Crossover Studies

Contributions to Tobacco & Nicotine Research
Volume 33 (2024): Issue 3 (June 2024)
By: Dai Yuki,  Lesley Giles,  Sylvain Larroque,  Sam Harbo,  Anthony Hemsley and  Javier Martinez  
Open Access
|Aug 2024

Figures & Tables

Figure 1.

Mean plasma nicotine concentration profiles in Study 1. Error bars correspond to standard error.
Mean plasma nicotine concentration profiles in Study 1. Error bars correspond to standard error.

Figure 2.

Mean plasma nicotine concentration profiles in Study 2. Errors bars correspond to standard error.
Mean plasma nicotine concentration profiles in Study 2. Errors bars correspond to standard error.

Figure 3.

Linear regression of (A) AUC0–last vs. nicotine consumption and (B) Cmax vs. nicotine consumption. Dot lines show the represented fixed effects regression between AUC0–last or Cmax and estimated nicotine consumption derived a linear mixed-model that adjusted the intercepts and slopes by study. R2 indicates the coefficient of determination derived from a simple linear regression (crude regression) taking all data of two studies.
Linear regression of (A) AUC0–last vs. nicotine consumption and (B) Cmax vs. nicotine consumption. Dot lines show the represented fixed effects regression between AUC0–last or Cmax and estimated nicotine consumption derived a linear mixed-model that adjusted the intercepts and slopes by study. R2 indicates the coefficient of determination derived from a simple linear regression (crude regression) taking all data of two studies.

Summary of the subjective effects measures, Study 2_

ParameterProduct AProduct BProduct CProduct DProduct EProduct FProduct G
eDNC2.0a Tobacco flavoreDNC2.0a Menthol flavoreDNC2.0a Cherry flavoreDNC2.0a Berry mint flavorUsual brand of combustible cigarettesNicotine inhalerReference e-cigarette
(n = 50)(n = 51)(n = 51)(n = 51)(n = 51)(n = 51)(n = 51)
Product liking VAS a
Emax – Mean (SD)41.5 (27.55)51.6 (28.00)51.1 (27.00)52.7 (28.73)77.7 (26.12)29.7 (28.56)58.2 (26.00)
> 50 to 100 mm – n (%)16 (32.0%)27 (52.9%)26 (51.0%)30 (58.8%)45 (88.2%)16 (31.4%)32 (62.7%)
Intent to use the product again VASb
Emax – Mean (SD)44.8 (28.86)53.1 (31.46)54.2 (25.60)55.3 (27.89)83.9 (20.31)24.3 (26.48)59.6 (25.11)
> 50 to 100 mm – n (%)31 (62.0%)34 (66.7%)39 (76.5%)32 (62.7%)48 (94.1%)16 (31.4%)43 (84.3%)
mPES, subscales c
Satisfaction – Mean (SD)2.9 (1.42)3.6 (1.71)3.4 (1.36)3.9 (1.66)5.2 (1.66)1.9 (1.04)3.8 (1.45)
Psychological Reward – Mean (SD)2.7 (1.49)2.7 (1.63)2.7 (1.63)2.9 (1.69)3.6 (1.84)2.1 (1.24)2.9 (1.54)
Aversion – Mean (SD)1.5 (0.89)1.5 (0.64)1.3 (0.65)1.3 (0.54)1.8 (0.94)1.3 (0.66)1.5 (0.72)
Relief – Mean (SD)3.1 (1.75)3.4 (1.84)3.4 (1.71)3.5 (1.91)4.4 (1.96)2.1 (1.45)3.5 (1.70)

Summary of the subjective effects measures, Study 1_

ParameterProduct AProduct BProduct CProduct DProduct EProduct F
eDNC1.0a Tobacco flavoreDNC1.0a Cherry flavoreDNC1.0a Menthol flavorUsual brand of combustible cigarettesNicotine gumReference e-cigarette
(n = 52)(n = 52)(n = 52)(n = 52)(n = 52)(n = 52)
Product liking VAS a
Emax – Mean (SD)54.5 (34.44)53.4 (30.32)56.7 (33.03)83.1 (22.80)52.0 (31.60)57.8 (31.58)
> 50 to 100 mm – n (%)32 (61.5%)32 (61.5%)33 (63.5%)47 (90.4%)30 (57.7%)36 (69.2%)
Intent to use the product again VAS b
Emax – Mean (SD)55.1 (33.70)49.3 (31.22)52.7 (36.15)90.4 (17.37)46.2 (36.19)54.2 (33.20)
> 50 to 100 mm – n (%)36 (69.2%)31 (59.6%)32 (61.5%)51 (98.1%)29 (55.8%)31 (59.6%)
mPES, subscales c
Satisfaction – Mean (SD)3.4 (1.74)3.4 (1.55)3.7 (1.79)5.3 (1.56)3.5 (1.76)3.6 (1.58)
Psychological reward – Mean (SD)2.8 (1.49)2.8 (1.37)2.8 (1.35)3.9 (1.67)2.7 (1.67)2.7 (1.42)
Aversion – Mean (SD)1.4 (0.59)1.3 (0.41)1.4 (0.74)2.1 (1.18)1.4 (0.77)1.2 (0.47)
Relief – Mean (SD)3.7 (2.15)4.0 (2.00)3.9 (1.86)5.5 (2.02)3.0 (1.91)4.0 (1.75)

Summary of the pharmacokinetic parameters for nicotine, Study 2_

Product AProduct BProduct CProduct DProduct EProduct FProduct G
eDNC2.0a Tobacco flavoreDNC2.0a Menthol flavoreDNC2.0a Cherry flavoreDNC2.0a Berry mint flavorUsual brand of combustible cigarettesNicotine inhalerReference e-cigarette
Parameter(n = 51)(n = 51)(n = 51)(n = 50) c(n = 51)(n = 50) c(n = 51 )
Cmax (ng/mL)
Geometric LS mean (95% CI) a4.22 (3.35, 5.31) b4.11 (3.27, 5.18) b3.52 (2.8, 4.44) b3.99 (3.16, 5.03) b12.30 (9.76, 15.49)1.95 (1.55, 2.46)5.74 (4.55, 7.22)
Min, Max0.31, 24.100.36, 17.400.30, 21.600.36, 16.604.38, 34.000.23, 13.000.43, 36.4.0
AUC0–last (ng×hr/mL)
Geometric LS mean (95% CI) a6.71 (5.14, 8.78) b6.62 (5.06, 8.66) b5.28 (4.04, 6.9) b6.17 (4.71, 8.08) b19.02 (14.55, 24.87)3.93 (3, 5.15)7.69 (5.88, 10.05)
Min, Max0.35, 23.170.53, 23.670.15, 17.330.58, 23.333.52, 50.330.02, 31.330.31, 33.33
Tmax (min)
Median10.010.015.010.07.340.07.0
Min, Max5.0, 41.03.0, 61.05.0, 60.05.0, 40.03.0, 40.07.0, 90.03.0, 40.0
Amount of e-liquid used (mg)
Mean (SD)58.2 (33.36)60.7 (34.54)62.4 (35.49)64.8 (39.62)N/AN/A48.2 (29.88)
Min, Max2.0, 171.03.7, 126.92.0, 160.22.2, 203.2 1.7, 116.8
Estimated nicotine consumption (mg)
Mean (SD)1.05 (0.601)1.09 (0.621)0.93 (0.529)0.96 (0.591)N/AN/A1.45 (0.896)
Min, Max0.04, 3.080.07, 2.280.03, 2.390.03, 3.03 0.05, 3.50

Summary of the pharmacokinetic parameters for nicotine, Study 1_

Product AProduct BProduct CProduct DProduct EProduct F
eDNC1.0a Tobacco flavoreDNC1.0a Cherry flavoreDNC1.0a Menthol flavorUsual brand of combustible cigarettesNicotine gumReference e-cigarette
Parameter(n = 52)(n = 52)(n = 52)(n = 52)(n = 52)(n = 52)
Cmax (ng/mL)
Geometric LS mean (95% CI) a3.71 (3.15, 4.37) b3.44 (2.92, 4.05) b4.18 (3.55, 4.92) b15.32 (13.00, 18.04)3.26 (2.77, 3.85)2.90 (2.46, 3.42)
Min, Max0.72, 17.200.65, 11.301.41, 13.505.52, 42.800.87, 10.100.66, 11.40
AUC0–last (ng × hr/mL)
Geometric LS mean (95% CI) a6.24 (5.37, 7.25) b5.62 (4.84, 6.54) b7.04 (6.06, 8.18) b21.09 (18.15, 24.52)8.21 (7.06, 9.54)4.64 (3.99, 5.39)
Min, Max0.92, 20.670.99, 14.532.22, 21.505.25, 45.331.98, 15.680.80, 12.77
Tmax (min)
Median15.015.015.07.145.215.0
Min, Max5.0, 60.07.0, 45.05.0, 60.03.0, 45.030.0, 90.05.0, 60.0
Amount of e-liquid used (mg)
Mean (SD)31.5 (16.31)29.6 (13.25)35.0 (19.44)N/AN/A28.2 (16.77)
Min, Max8.0, 73.77.1, 64.410.2, 104.2 5.9, 73.9
Estimated nicotine consumption (mg)
Mean (SD)0.75 (0.391)0.71 (0.318)0.84 (0.467)N/AN/A0.68 (0.402)
Min, Max0.19, 1.770.17, 1.550.24, 2.50 0.14, 1.77

Demographic characteristics by study group, Study 1_

AFBECDBACFDECBDAEFDCEBFAEDFCABFEADBCTOTAL
(N = 9)(N = 10)(N = 9)(N = 8)(N = 9)(N = 7)(N = 52)
Sex
Male, n (%)5 (55.6%)5 (50.0%)7 (77.8%)4 (50.0%)6 (66.7%)4 (57.1%)31 (59.6%)
Female, n (%)4 (44.4%)5 (50.0%)2 (22.2%)4 (50.0%)3 (33.3%)3 (42.9%)21 (40.4%)
Age, years Mean (SD)40.6 (9.17)37.9 (10.19)40.8 (7.90)44.5 (8.73)38.0 (11.91)39.7 (9.23)40.1 (9.43)
Race
White, n (%)9 (100.0%)8 (80.0%)9 (100.0%)6 (75.0%)7 (77.8%)5 (71.4%)44 (84.6%)
African American, n (%)0 (0.0%)2 (20.0%)0 (0.0%)2 (25.0%)2 (22.2%)2 (28.6%)8 (15.4%)
Other, n (%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)
BMI, kg/m2 Mean (SD)27.0 (4.55)24.9 (2.61)27.3 (4.23)24.9 (2.75)24.8 (3.46)25.3 (2.36)25.7 (3.45)
CPD, Mean (SD)15.9 (4.70)18.8 (5.47)18.6 (6.23)17.6 (3.50)18.8 (8.45)15.3 (4.72)17.6 (5.68)
Regular smoking flavor
Non-menthol, n (%)5 (55.6%)6 (60.0%)7 (77.8%)5 (62.5%)3 (33.3%)3 (42.9%)29 (55.8%)
Menthol, n (%)4 (44.4%)4 (40.0%)2 (22.2%)3 (37.5%)6 (66.7%)4 (57.1%)23 (44.2%)
FTCD, Mean (SD)3.9 (0.93)5.3 (1.42)5.2 (1.39)5.0 (1.77)4.8 (1.72)5.0 (2.00)4.9 (1.55)

Demographic characteristics by study group, Study 2_

ABGCFDEAGBFCEDBACGDFEBCADGEFCBDAEGFCDBEAFGDCEBFAGDECFBGAEDFCGBAEFDGCABFEGDACBFGEADBCGAFBECDGFAEBDCTOTAL
(N= 3)(N= 2)(N= 4)(N= 4)(N= 3)(N= 4)(N= 3)(N= 4)(N= 4)(N= 4)(N= 4)(N= 4)(N= 4)(N= 4)(N= 51)
Sex
Male, n(%)3 (100.0%)2 (100.0%)3 (75.0%)2 (50.0%)2 (66.7%)4 (100.0%)2 (66.7%)2 (50.0%)1 (25.0%)3 (75.0%)1 (25.0%)3 (75.0%)3 (75.0%)2 (50.0%)33 (64.7%)
Female, n (%)0 (0.0%)0 (0.0%)1 (25.0%)2 (50.0%)1 (33.3%)0 (0.0%)1 (33.3%)2 (50.0%)3 (75.0%)1 (25.0%)3 (75.0%)1 (25.0%)1 (25.0%)2 (50.0%)18 (35.3%)
Age, years, Mean (SD)27.3 (5.13)26.5 (0.71)41.0 (13.44)28.0 (2.16)39.3 (10.60)39.0 (11.60)29.7 (8.62)43.3 (9.43)31.8 (10.05)39.0 (4.97)41.8 (14.59)45.8 (15.95)46.8 (11.21)42.3 (10.69)38.0 (11.27)
Race
White,n (%)2 (66.7%)2 (100.0%)2 (50.0%)4 (100.0%)3 (100.0%)4 (100.0%)1 (33.3%)4 (100.0%)3 (75%)4 (100.0%)3 (75.0%)4 (100.0%)4 (100.0%)4 (100.0%)44 (86.3%)
African American, n (%)0 (0.0%)0 (0.0%)2 (50.0%)0 (0.0%)0 (0.0%)0 (0.0%)2 (66.7%)0 (0.0%)1 (25%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)5 (9.8%)
Other, n (%)1 (33.3%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)1 (25.0%)0 (0.0%)0 (0.0%)0 (0.0%)2 (3.9%)
BMI, kg/m2Mean (SD)23.3 (3.59)31.6 (3.01)28.6 (4.52)24.8 (2.27)28.4 (2.13)29.9 (5.75)25.8 (6.08)27.8 (3.45)25.7 (5.51)28.5 (5.06)23.7 (3.52)27.3 (3.10)27.8 (3.76)26.1 (6.05)27.0 (4.33)
CPD, Mean (SD)17.3 (4.62)20.0 (0.00)15.5 (5.26)13.8 (4.79)14.0 (5.29)17.5 (5.00)12.0 (2.65)18.8 (8.54)11.5 (2.38)17.5 (2.89)20.0 (0.00)13.5 (4.43)17.5 (2.89)19.5 (1.00)16.3 (4.64)
Regular smoking flavor
Non-menthol, n (%)3 (100.0%)0 (0.0%)0 (0.0%)2 (50.0%)1 (33.3%)2 (50.0%)0 (0.0%)2 (50.0%)3 (75.0%)4 (100.0%)3 (75.0%)1 (25.0%)2 (50.0%)4 (100.0%)27 (52.9%)
Menthol, n (%)0 (0.0%)2 (100.0%)4 (100.0%)2 (50.0%)2 (66.7%)2 (50.0%)3 (100.0%)2 (50.0%)1 (25.0%)0 (0.0%)1 (25.0%)3 (75.0%)2 (50.0%)0 (0.0%)24 (47.1%)
FTCD, Mean (SD)3.3 (2.31)5.5 (2.12)4.8 (1.26)3.0 (2.71)5.0 (3.61)5.0 (1.63)5.3 (0.58)5.3 (1.50)5.0 (2.16)5.0 (1.42)5.0 (1.42)3.8 (1.72)5.5 (2.38)5.5 (1.29)4.8 (1.85)

Study product characteristics_

StudyProductShort codeArticleBrandCategoryDevice typeFlavorNicotine content of e-liquid (%)Regimen
Study 1AeDNC1.0aTestLogic PowerE-cigaretteCig-a-likeTobacco2.4%(w/w)ad libitum, 5 min use
BeDNC1.0aTestLogic PowerE-cigaretteCig-a-likeCherry2.4% (w/w)ad libitum, 5 min use
CeDNC1.0aTestLogic PowerE-cigaretteCig-a-likeMenthol2.4% (w/w)ad libitum, 5 min use
DCCComparatorN/ACigaretteN/AN/AN/Aad libitum, one cigarette (up to 5 min)
ENicotine gumBenchmarkNicorette® Gum, White Ice Mint, 2 mgNicotine gumN/AN/AN/Aad libitum, 30 min use
FReference e-cigaretteBenchmarkblu PLUS+E-cigaretteCig-a-likeTobacco2.4% (w/w)ad libitum, 5 min use
Study 2AeDNC2.0aTestLogic ProE-cigaretteClosed tankTobacco1.80%(w/w)ad libitum, 5 min use
BeDNC2.0aTestLogic ProE-cigaretteClosed tankMenthol1.80% (w/w)ad libitum, 5 min use
CeDNC2.0aTestLogic ProE-cigaretteClosed tankCherry1.49% (w/w)ad libitum, 5 min use
DeDNC2.0aTestLogic ProE-cigaretteClosed tankBerry Mint1.49% (w/w)ad libitum, 5 min use
ECCComparatorN/ACigaretteN/AN/AN/Aad libitum, one cigarette (up to 5 min)
FNicotine inhalerBenchmarkNicotrol®Inhaler, 10 mg per cartridgeNicotine inhalerN/AN/AN/Aad libitum, 20 min use
GReference e-cigaretteBenchmarkVuse VibeE-cigaretteClosed tankTobacco3.0% (w/w)ad libitum, 5 min use
DOI: https://doi.org/10.2478/cttr-2024-0007 | Journal eISSN: 2719-9509
Journal RSS Feed
Language: English
Page range: 173 - 188
Submitted on: Jan 28, 2024
Accepted on: Apr 24, 2024
Published on: Aug 21, 2024
Published by: Institut für Tabakforschung GmbH
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
Clinical study,
e-cigarette,
nicotine pharmacokinetics
Related subjects:
General interest,
Life sciences,
Life sciences, other,
Physics,
Physics, other

© 2024 Dai Yuki, Lesley Giles, Sylvain Larroque, Sam Harbo, Anthony Hemsley, Javier Martinez, published by Institut für Tabakforschung GmbH
This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License.

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