Trial Outcomes & Findings for Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers (NCT NCT05317195)
NCT ID: NCT05317195
Last Updated: 2024-09-27
Results Overview
To measure the background-corrected maximum plasma concentration \[Cmax\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).
Results posted on
2024-09-27
Participant Flow
31 subjects were enrolled in the study, which was conducted at a clinical trial facility managed by a contract research organization.
Of the 31 enrolled subjects who performed a product test, 24 were randomized to product use. Seven of the 31 enrolled subjects were not randomized because only 24 subjects were required for the study.
Participant milestones
| Measure |
All Study Participants
All study participants.
|
|---|---|
|
Product Test (Enrolled Subjects)
STARTED
|
31
|
|
Product Test (Enrolled Subjects)
COMPLETED
|
31
|
|
Product Test (Enrolled Subjects)
NOT COMPLETED
|
0
|
|
Randomization
STARTED
|
31
|
|
Randomization
COMPLETED
|
24
|
|
Randomization
NOT COMPLETED
|
7
|
|
Admission
STARTED
|
24
|
|
Admission
COMPLETED
|
22
|
|
Admission
NOT COMPLETED
|
2
|
|
Product Use (Randomized Subjects)
STARTED
|
22
|
|
Product Use (Randomized Subjects)
NP-1
|
22
|
|
Product Use (Randomized Subjects)
NP-2
|
22
|
|
Product Use (Randomized Subjects)
NP-3
|
22
|
|
Product Use (Randomized Subjects)
NP-4
|
22
|
|
Product Use (Randomized Subjects)
Velo-NP
|
22
|
|
Product Use (Randomized Subjects)
Zyn-NP
|
22
|
|
Product Use (Randomized Subjects)
COMPLETED
|
22
|
|
Product Use (Randomized Subjects)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Study Participants
All study participants.
|
|---|---|
|
Randomization
Withdrawal by Subject
|
1
|
|
Randomization
Discontinued
|
6
|
|
Admission
Withdrawal by Subject
|
2
|
Baseline Characteristics
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Baseline characteristics by cohort
| Measure |
Safety Population
n=31 Participants
The safety population was a subset of the screened population and comprised all the subjects who signed ICF consent and had at least one exposure to NP 1.0 (including the product test with NP-1 at Admission).
|
|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Fagerström score
|
5.2 units on a scale
STANDARD_DEVIATION 1.59 • n=5 Participants
|
PRIMARY outcome
Timeframe: T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).To measure the background-corrected maximum plasma concentration \[Cmax\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=21 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Background-corrected Maximum Plasma Concentration [Cmax]
|
8.109 ng/mL
Interval 6.57 to 9.649
|
11.48 ng/mL
Interval 9.544 to 13.42
|
2.629 ng/mL
Interval 1.67 to 3.588
|
3.464 ng/mL
Interval 2.929 to 3.999
|
11.32 ng/mL
Interval 9.88 to 12.75
|
9.257 ng/mL
Interval 8.066 to 10.45
|
PRIMARY outcome
Timeframe: T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).To measure the background-corrected time to the maximum concentration \[Tmax\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=21 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Background-corrected Time to the Maximum Concentration [Tmax]
|
35.70 minutes
Interval 10.1 to 179.0
|
34.80 minutes
Interval 9.96 to 60.4
|
34.89 minutes
Interval 9.72 to 60.7
|
34.98 minutes
Interval 29.8 to 64.3
|
33.99 minutes
Interval 9.72 to 180.0
|
34.95 minutes
Interval 22.9 to 59.7
|
PRIMARY outcome
Timeframe: T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=21 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)
|
128.2 min*ng/mL
Interval 97.73 to 158.6
|
217.3 min*ng/mL
Interval 177.6 to 256.9
|
41.35 min*ng/mL
Interval 28.28 to 54.42
|
49.30 min*ng/mL
Interval 40.87 to 57.73
|
201.3 min*ng/mL
Interval 173.9 to 228.7
|
136.0 min*ng/mL
Interval 112.6 to 159.3
|
SECONDARY outcome
Timeframe: Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)To measure cigarette craving by the visual analog scale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Craving was assessed at selected time points on a scale from "no craving" (0 mm) to "strong craving" (100 mm) by measuring the number of millimeters (0-100 mm) from the "no craving" point to the point at which the drawn line intersected the scale.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=22 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
5 min Post-Product Use
|
38.5 score on a scale
Interval 26.5 to 50.6
|
38.1 score on a scale
Interval 26.5 to 49.7
|
50.3 score on a scale
Interval 38.2 to 62.5
|
42.6 score on a scale
Interval 30.8 to 54.4
|
38.7 score on a scale
Interval 26.8 to 50.7
|
39.4 score on a scale
Interval 25.7 to 53.1
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
15 min Post-Product Use
|
27.3 score on a scale
Interval 16.8 to 37.7
|
29.9 score on a scale
Interval 17.7 to 42.1
|
39.5 score on a scale
Interval 26.4 to 52.6
|
36.5 score on a scale
Interval 23.8 to 49.3
|
31.7 score on a scale
Interval 21.1 to 42.3
|
26.9 score on a scale
Interval 15.8 to 37.9
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
Pre-Product Use
|
61.0 score on a scale
Interval 46.7 to 75.2
|
62.6 score on a scale
Interval 49.6 to 75.6
|
64.3 score on a scale
Interval 51.4 to 77.1
|
67.4 score on a scale
Interval 55.0 to 79.8
|
68.6 score on a scale
Interval 56.8 to 80.4
|
68.9 score on a scale
Interval 54.9 to 82.8
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
10 min Post-Product Use
|
36.4 score on a scale
Interval 23.1 to 49.7
|
33.8 score on a scale
Interval 22.1 to 45.5
|
43.0 score on a scale
Interval 29.9 to 56.1
|
38.6 score on a scale
Interval 26.9 to 50.3
|
34.3 score on a scale
Interval 23.2 to 45.5
|
29.0 score on a scale
Interval 18.1 to 40.0
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
20 min Post-Product Use
|
29.2 score on a scale
Interval 18.5 to 39.9
|
31.7 score on a scale
Interval 19.2 to 44.3
|
38.0 score on a scale
Interval 24.8 to 51.2
|
36.4 score on a scale
Interval 23.8 to 48.9
|
26.9 score on a scale
Interval 16.4 to 37.3
|
22.7 score on a scale
Interval 12.6 to 32.8
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
25 min Post-Product Use
|
29.1 score on a scale
Interval 18.2 to 40.1
|
28.6 score on a scale
Interval 17.3 to 39.8
|
46.1 score on a scale
Interval 32.3 to 59.9
|
35.8 score on a scale
Interval 24.4 to 47.3
|
24.1 score on a scale
Interval 14.6 to 33.5
|
20.0 score on a scale
Interval 11.8 to 28.3
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
30 min Post-Product Use
|
28.8 score on a scale
Interval 17.0 to 40.6
|
28.3 score on a scale
Interval 17.1 to 39.5
|
37.2 score on a scale
Interval 24.3 to 50.0
|
35.4 score on a scale
Interval 23.5 to 47.3
|
24.2 score on a scale
Interval 13.7 to 34.8
|
19.5 score on a scale
Interval 10.4 to 28.7
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
35 min Post-Product Use
|
27.2 score on a scale
Interval 16.2 to 38.1
|
27.1 score on a scale
Interval 16.0 to 38.2
|
36.9 score on a scale
Interval 23.5 to 50.2
|
33.7 score on a scale
Interval 21.0 to 46.4
|
23.4 score on a scale
Interval 13.5 to 33.2
|
19.5 score on a scale
Interval 9.7 to 29.3
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
40 min Post-Product Use
|
29.0 score on a scale
Interval 17.2 to 40.9
|
29.5 score on a scale
Interval 18.3 to 40.7
|
34.6 score on a scale
Interval 22.2 to 46.9
|
33.5 score on a scale
Interval 20.5 to 46.5
|
22.8 score on a scale
Interval 13.0 to 32.6
|
21.1 score on a scale
Interval 11.4 to 30.9
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
1 hr Post-Product Use
|
26.8 score on a scale
Interval 15.8 to 37.7
|
32.0 score on a scale
Interval 20.3 to 43.7
|
44.9 score on a scale
Interval 31.4 to 58.4
|
35.8 score on a scale
Interval 23.6 to 48.0
|
24.3 score on a scale
Interval 14.4 to 34.3
|
24.7 score on a scale
Interval 14.5 to 34.9
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
3 hr Post-Product Use
|
45.8 score on a scale
Interval 31.3 to 60.3
|
52.8 score on a scale
Interval 40.4 to 65.3
|
53.9 score on a scale
Interval 41.5 to 66.2
|
51.5 score on a scale
Interval 38.3 to 64.7
|
42.1 score on a scale
Interval 30.1 to 54.2
|
48.4 score on a scale
Interval 34.7 to 62.0
|
|
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
6 hr Post-Product Use
|
58.3 score on a scale
Interval 44.5 to 72.1
|
60.1 score on a scale
Interval 46.1 to 74.1
|
64.2 score on a scale
Interval 50.4 to 77.9
|
57.8 score on a scale
Interval 45.0 to 70.6
|
57.0 score on a scale
Interval 43.0 to 70.9
|
54.2 score on a scale
Interval 39.9 to 68.5
|
SECONDARY outcome
Timeframe: Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=22 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
5 min Post-Product Use
|
49.7 score on a scale
Interval 39.6 to 59.8
|
55.8 score on a scale
Interval 48.2 to 63.5
|
50.1 score on a scale
Interval 41.0 to 59.2
|
48.2 score on a scale
Interval 39.3 to 57.1
|
51.7 score on a scale
Interval 44.3 to 59.1
|
60.2 score on a scale
Interval 51.9 to 68.5
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
10 min Post-Product Use
|
54.8 score on a scale
Interval 43.7 to 65.8
|
56.2 score on a scale
Interval 45.7 to 66.7
|
52.1 score on a scale
Interval 42.8 to 61.4
|
52.1 score on a scale
Interval 42.8 to 61.5
|
55.8 score on a scale
Interval 47.1 to 64.5
|
60.6 score on a scale
Interval 50.0 to 71.2
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
15 min Post-Product Use
|
59.2 score on a scale
Interval 49.0 to 69.5
|
57.2 score on a scale
Interval 45.5 to 68.9
|
52.4 score on a scale
Interval 41.7 to 63.1
|
52.7 score on a scale
Interval 43.9 to 61.5
|
56.1 score on a scale
Interval 46.7 to 65.5
|
58.7 score on a scale
Interval 47.2 to 70.3
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
20 min Post-Product Use
|
51.5 score on a scale
Interval 39.7 to 63.2
|
53.8 score on a scale
Interval 41.6 to 66.0
|
52.1 score on a scale
Interval 41.4 to 62.8
|
54.5 score on a scale
Interval 45.4 to 63.7
|
58.7 score on a scale
Interval 47.1 to 70.3
|
60.3 score on a scale
Interval 47.7 to 72.9
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
25 min Post-Product Use
|
54.6 score on a scale
Interval 42.5 to 66.8
|
54.0 score on a scale
Interval 42.4 to 65.7
|
51.4 score on a scale
Interval 39.7 to 63.1
|
52.7 score on a scale
Interval 43.3 to 62.2
|
54.7 score on a scale
Interval 41.0 to 68.4
|
61.6 score on a scale
Interval 49.7 to 73.5
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
30 min Post-Product Use
|
60.0 score on a scale
Interval 48.1 to 71.8
|
53.5 score on a scale
Interval 40.5 to 66.5
|
52.0 score on a scale
Interval 41.5 to 62.6
|
51.7 score on a scale
Interval 41.1 to 62.3
|
57.7 score on a scale
Interval 44.8 to 70.7
|
59.9 score on a scale
Interval 47.5 to 72.3
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
35 min Post-Product Use
|
55.2 score on a scale
Interval 42.6 to 67.8
|
56.5 score on a scale
Interval 44.9 to 68.1
|
51.4 score on a scale
Interval 40.4 to 62.3
|
54.0 score on a scale
Interval 43.8 to 64.2
|
57.0 score on a scale
Interval 44.4 to 69.6
|
59.4 score on a scale
Interval 45.6 to 73.2
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
40 min Post-Product Use
|
56.7 score on a scale
Interval 44.0 to 69.4
|
54.2 score on a scale
Interval 42.0 to 66.4
|
51.4 score on a scale
Interval 40.3 to 62.6
|
53.6 score on a scale
Interval 43.0 to 64.3
|
57.2 score on a scale
Interval 45.2 to 69.3
|
58.7 score on a scale
Interval 45.7 to 71.7
|
|
Score of "in the Moment" Product Liking by the VAS-liking Assessment
1 hr Post-Product Use
|
54.7 score on a scale
Interval 41.8 to 67.6
|
54.5 score on a scale
Interval 43.0 to 65.9
|
49.8 score on a scale
Interval 39.1 to 60.4
|
53.4 score on a scale
Interval 43.5 to 63.2
|
55.6 score on a scale
Interval 43.7 to 67.6
|
58.2 score on a scale
Interval 45.9 to 70.5
|
SECONDARY outcome
Timeframe: Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Overall product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=22 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Score of Overall Product Liking by the VAS-liking Assessment
|
56.5 score on a scale
Interval 46.8 to 66.3
|
53.2 score on a scale
Interval 44.6 to 61.8
|
49.0 score on a scale
Interval 40.1 to 57.9
|
49.5 score on a scale
Interval 40.2 to 58.9
|
49.9 score on a scale
Interval 39.3 to 60.5
|
52.3 score on a scale
Interval 40.7 to 64.0
|
SECONDARY outcome
Timeframe: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product satisfaction was was assessed at selected time points on a scale from "not at all" (0 mm) to "extremely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "not at all" point to the point at which the drawn line intersected the scale.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=22 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
1 hr Post-Product Use
|
54.2 score on a scale
Interval 40.5 to 67.8
|
52.6 score on a scale
Interval 40.3 to 65.0
|
43.5 score on a scale
Interval 31.5 to 55.6
|
50.3 score on a scale
Interval 38.9 to 61.8
|
57.9 score on a scale
Interval 46.4 to 69.4
|
59.5 score on a scale
Interval 47.4 to 71.5
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
3 hr Post-Product Use
|
46.2 score on a scale
Interval 34.5 to 58.0
|
37.3 score on a scale
Interval 27.2 to 47.4
|
36.9 score on a scale
Interval 26.3 to 47.5
|
37.3 score on a scale
Interval 27.1 to 47.6
|
44.4 score on a scale
Interval 33.2 to 55.5
|
38.1 score on a scale
Interval 25.0 to 51.3
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
6 hr Post-Product Use
|
32.6 score on a scale
Interval 21.0 to 44.2
|
26.7 score on a scale
Interval 15.4 to 38.0
|
33.6 score on a scale
Interval 23.0 to 44.2
|
33.2 score on a scale
Interval 23.3 to 43.1
|
29.2 score on a scale
Interval 19.7 to 38.7
|
35.4 score on a scale
Interval 23.0 to 47.7
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
5 min Post-Product Use
|
52.5 score on a scale
Interval 42.3 to 62.6
|
51.5 score on a scale
Interval 41.0 to 62.0
|
45.8 score on a scale
Interval 35.8 to 55.8
|
50.2 score on a scale
Interval 41.2 to 59.2
|
48.4 score on a scale
Interval 39.9 to 56.9
|
55.8 score on a scale
Interval 45.2 to 66.3
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
10 min Post-Product Use
|
58.0 score on a scale
Interval 46.6 to 69.3
|
57.4 score on a scale
Interval 46.5 to 68.4
|
48.2 score on a scale
Interval 37.4 to 59.1
|
50.0 score on a scale
Interval 39.9 to 60.2
|
54.5 score on a scale
Interval 45.1 to 63.8
|
62.0 score on a scale
Interval 52.0 to 72.1
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
15 min Post-Product Use
|
60.9 score on a scale
Interval 50.9 to 70.8
|
57.9 score on a scale
Interval 46.3 to 69.5
|
50.5 score on a scale
Interval 40.3 to 60.8
|
49.5 score on a scale
Interval 39.4 to 59.5
|
57.5 score on a scale
Interval 48.4 to 66.7
|
62.4 score on a scale
Interval 50.1 to 74.7
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
20 min Post-Product Use
|
61.1 score on a scale
Interval 50.4 to 71.9
|
52.0 score on a scale
Interval 38.3 to 65.8
|
49.7 score on a scale
Interval 39.0 to 60.4
|
49.3 score on a scale
Interval 38.5 to 60.1
|
61.0 score on a scale
Interval 49.4 to 72.6
|
65.2 score on a scale
Interval 53.3 to 77.1
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
25 min Post-Product Use
|
54.2 score on a scale
Interval 41.3 to 67.1
|
56.8 score on a scale
Interval 46.0 to 67.7
|
50.1 score on a scale
Interval 38.8 to 61.4
|
50.8 score on a scale
Interval 39.8 to 61.7
|
58.2 score on a scale
Interval 45.7 to 70.6
|
67.5 score on a scale
Interval 55.7 to 79.2
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
30 min Post-Product Use
|
60.6 score on a scale
Interval 47.5 to 73.6
|
58.2 score on a scale
Interval 46.8 to 69.7
|
50.4 score on a scale
Interval 39.4 to 61.4
|
50.2 score on a scale
Interval 38.4 to 62.0
|
61.6 score on a scale
Interval 49.2 to 74.0
|
67.3 score on a scale
Interval 54.8 to 79.8
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
35 min Post-Product Use
|
61.2 score on a scale
Interval 49.9 to 72.5
|
56.0 score on a scale
Interval 44.2 to 67.9
|
46.0 score on a scale
Interval 34.6 to 57.5
|
52.9 score on a scale
Interval 41.4 to 64.4
|
60.4 score on a scale
Interval 48.4 to 72.4
|
65.1 score on a scale
Interval 53.4 to 76.9
|
|
Score of Product Satisfaction by the VAS-satisfaction Assessment
40 min Post-Product Use
|
59.0 score on a scale
Interval 45.9 to 72.2
|
53.2 score on a scale
Interval 40.1 to 66.3
|
44.4 score on a scale
Interval 31.8 to 57.0
|
51.7 score on a scale
Interval 39.4 to 63.9
|
61.4 score on a scale
Interval 51.0 to 71.8
|
60.5 score on a scale
Interval 47.8 to 73.1
|
SECONDARY outcome
Timeframe: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Intention to use again was was assessed at selected time points on a scale from "very unlikely" (0 mm) to "very likely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "very unlikely" point to the point at which the drawn line intersected the scale.
Outcome measures
| Measure |
NP-1
n=22 Participants
Nicotine Pouch 1.0 (variant NP-1)
NP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
|
NP-2
n=22 Participants
Nicotine Pouch 1.0 (variant NP-2)
NP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
|
NP-3
n=22 Participants
Nicotine Pouch 1.0 (variant NP-3)
NP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
|
NP-4
n=22 Participants
Nicotine Pouch 1.0 (variant NP-4)
NP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
|
Velo-NP
n=22 Participants
Velo® Ice Cool
Velo-NP: Velo-NP; 10 mg nicotine;
|
Zyn-NP
n=22 Participants
Zyn® Cool Mint Mini Dry
Zyn-NP: Zyn-NP; 3 mg nicotine;
|
|---|---|---|---|---|---|---|
|
Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment
30 min Post-Product Use
|
51.3 score on a scale
Interval 37.7 to 64.9
|
52.0 score on a scale
Interval 38.8 to 65.1
|
46.7 score on a scale
Interval 35.1 to 58.2
|
48.3 score on a scale
Interval 36.2 to 60.3
|
55.3 score on a scale
Interval 42.9 to 67.6
|
57.9 score on a scale
Interval 43.2 to 72.6
|
|
Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment
3 hr Post-Product Use
|
48.8 score on a scale
Interval 35.6 to 61.9
|
48.1 score on a scale
Interval 37.8 to 58.4
|
51.6 score on a scale
Interval 42.5 to 60.6
|
44.5 score on a scale
Interval 33.0 to 55.9
|
50.9 score on a scale
Interval 39.5 to 62.2
|
49.5 score on a scale
Interval 35.3 to 63.7
|
Adverse Events
Safety Population (NP-1 Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (NP-1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (NP-2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (NP-3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (NP-4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (Velo-NP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Population (Zyn-NP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christelle Haziza, Global Head Clinical Research and Execution
Philip Morris Products S.A.
Phone: +41 58 242 11 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER