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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

Dai Yuki

Dai Yuki

  • JT InternationalGeneva, Switzerland
  • Japan Tobacco IncTokyo, Japan
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Yuki, Dai
, 
Lesley Giles

Lesley Giles

JT InternationalGeneva, Switzerland
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Giles, Lesley
, 
Sylvain Larroque

Sylvain Larroque

JT InternationalGeneva, Switzerland
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Larroque, Sylvain
, 
Sam Harbo

Sam Harbo

JT InternationalGeneva, Switzerland
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Harbo, Sam
, 
Anthony Hemsley

Anthony Hemsley

JT InternationalGeneva, Switzerland
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Hemsley, Anthony
 y 
Javier Martinez

Javier Martinez

JT InternationalGeneva, Switzerland
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Martinez, Javier
  
21 ago 2024
Assessment of the Nicotine Pharmacokinetics When Using Two Types of E-Cigarettes in Healthy Adults Who Smoke: Results From Two Randomized, Crossover Studies's Cover Image
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Publicado en línea: 21 ago 2024
Páginas: 173 - 188
Recibido: 28 ene 2024
Aceptado: 24 abr 2024
DOI: https://doi.org/10.2478/cttr-2024-0007
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© 2024 Dai Yuki et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

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_

Parameter Product A Product B Product C Product D Product E Product F Product G
eDNC2.0a Tobacco flavor eDNC2.0a Menthol flavor eDNC2.0a Cherry flavor eDNC2.0a Berry mint flavor Usual brand of combustible cigarettes Nicotine inhaler Reference 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_

Parameter Product A Product B Product C Product D Product E Product F
eDNC1.0a Tobacco flavor eDNC1.0a Cherry flavor eDNC1.0a Menthol flavor Usual brand of combustible cigarettes Nicotine gum Reference 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 A Product B Product C Product D Product E Product F Product G
eDNC2.0a Tobacco flavor eDNC2.0a Menthol flavor eDNC2.0a Cherry flavor eDNC2.0a Berry mint flavor Usual brand of combustible cigarettes Nicotine inhaler Reference 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) a 4.22 (3.35, 5.31) b 4.11 (3.27, 5.18) b 3.52 (2.8, 4.44) b 3.99 (3.16, 5.03) b 12.30 (9.76, 15.49) 1.95 (1.55, 2.46) 5.74 (4.55, 7.22)
Min, Max 0.31, 24.10 0.36, 17.40 0.30, 21.60 0.36, 16.60 4.38, 34.00 0.23, 13.00 0.43, 36.4.0
AUC0–last (ng×hr/mL)
Geometric LS mean (95% CI) a 6.71 (5.14, 8.78) b 6.62 (5.06, 8.66) b 5.28 (4.04, 6.9) b 6.17 (4.71, 8.08) b 19.02 (14.55, 24.87) 3.93 (3, 5.15) 7.69 (5.88, 10.05)
Min, Max 0.35, 23.17 0.53, 23.67 0.15, 17.33 0.58, 23.33 3.52, 50.33 0.02, 31.33 0.31, 33.33
Tmax (min)
Median 10.0 10.0 15.0 10.0 7.3 40.0 7.0
Min, Max 5.0, 41.0 3.0, 61.0 5.0, 60.0 5.0, 40.0 3.0, 40.0 7.0, 90.0 3.0, 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/A N/A 48.2 (29.88)
Min, Max 2.0, 171.0 3.7, 126.9 2.0, 160.2 2.2, 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/A N/A 1.45 (0.896)
Min, Max 0.04, 3.08 0.07, 2.28 0.03, 2.39 0.03, 3.03 0.05, 3.50

Summary of the pharmacokinetic parameters for nicotine, Study 1_

Product A Product B Product C Product D Product E Product F
eDNC1.0a Tobacco flavor eDNC1.0a Cherry flavor eDNC1.0a Menthol flavor Usual brand of combustible cigarettes Nicotine gum Reference e-cigarette
Parameter (n = 52) (n = 52) (n = 52) (n = 52) (n = 52) (n = 52)
Cmax (ng/mL)
Geometric LS mean (95% CI) a 3.71 (3.15, 4.37) b 3.44 (2.92, 4.05) b 4.18 (3.55, 4.92) b 15.32 (13.00, 18.04) 3.26 (2.77, 3.85) 2.90 (2.46, 3.42)
Min, Max 0.72, 17.20 0.65, 11.30 1.41, 13.50 5.52, 42.80 0.87, 10.10 0.66, 11.40
AUC0–last (ng × hr/mL)
Geometric LS mean (95% CI) a 6.24 (5.37, 7.25) b 5.62 (4.84, 6.54) b 7.04 (6.06, 8.18) b 21.09 (18.15, 24.52) 8.21 (7.06, 9.54) 4.64 (3.99, 5.39)
Min, Max 0.92, 20.67 0.99, 14.53 2.22, 21.50 5.25, 45.33 1.98, 15.68 0.80, 12.77
Tmax (min)
Median 15.0 15.0 15.0 7.1 45.2 15.0
Min, Max 5.0, 60.0 7.0, 45.0 5.0, 60.0 3.0, 45.0 30.0, 90.0 5.0, 60.0
Amount of e-liquid used (mg)
Mean (SD) 31.5 (16.31) 29.6 (13.25) 35.0 (19.44) N/A N/A 28.2 (16.77)
Min, Max 8.0, 73.7 7.1, 64.4 10.2, 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/A N/A 0.68 (0.402)
Min, Max 0.19, 1.77 0.17, 1.55 0.24, 2.50 0.14, 1.77

Demographic characteristics by study group, Study 1_

AFBECD BACFDE CBDAEF DCEBFA EDFCAB FEADBC TOTAL
(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_

ABGCFDE AGBFCED BACGDFE BCADGEF CBDAEGF CDBEAFG DCEBFAG DECFBGA EDFCGBA EFDGCAB FEGDACB FGEADBC GAFBECD GFAEBDC TOTAL
(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_

Study Product Short code Article Brand Category Device type Flavor Nicotine content of e-liquid (%) Regimen
Study 1 A eDNC1.0a Test Logic Power E-cigarette Cig-a-like Tobacco 2.4%(w/w) ad libitum, 5 min use
B eDNC1.0a Test Logic Power E-cigarette Cig-a-like Cherry 2.4% (w/w) ad libitum, 5 min use
C eDNC1.0a Test Logic Power E-cigarette Cig-a-like Menthol 2.4% (w/w) ad libitum, 5 min use
D CC Comparator N/A Cigarette N/A N/A N/A ad libitum, one cigarette (up to 5 min)
E Nicotine gum Benchmark Nicorette® Gum, White Ice Mint, 2 mg Nicotine gum N/A N/A N/A ad libitum, 30 min use
F Reference e-cigarette Benchmark blu PLUS+ E-cigarette Cig-a-like Tobacco 2.4% (w/w) ad libitum, 5 min use
Study 2 A eDNC2.0a Test Logic Pro E-cigarette Closed tank Tobacco 1.80%(w/w) ad libitum, 5 min use
B eDNC2.0a Test Logic Pro E-cigarette Closed tank Menthol 1.80% (w/w) ad libitum, 5 min use
C eDNC2.0a Test Logic Pro E-cigarette Closed tank Cherry 1.49% (w/w) ad libitum, 5 min use
D eDNC2.0a Test Logic Pro E-cigarette Closed tank Berry Mint 1.49% (w/w) ad libitum, 5 min use
E CC Comparator N/A Cigarette N/A N/A N/A ad libitum, one cigarette (up to 5 min)
F Nicotine inhaler Benchmark Nicotrol®Inhaler, 10 mg per cartridge Nicotine inhaler N/A N/A N/A ad libitum, 20 min use
G Reference e-cigarette Benchmark Vuse Vibe E-cigarette Closed tank Tobacco 3.0% (w/w) ad libitum, 5 min use
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