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Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers

A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05317195
Enrollment
31
Registered
2022-04-07
Start date
2022-03-15
Completion date
2022-08-18
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine, Smoking

Keywords

Nicotine-containing products, Nicotine delivery

Brief summary

This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).

Detailed description

Study Title: Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers Who carried out the research? This research was sponsored and funded by Philip Morris Products S.A. What public involvement there was in the study? The study recruited 31 healthy adults who were currently smoking. Where and when the study took place The study was conducted at a clinical trial facility managed by a contract research organization in Belfast, Northern Ireland, from March 15th to August 18th 2022. Why was the research needed? The research was needed to understand the pharmacokinetic profiles of four variants of a nicotine pouch. What were the main questions studied? The study measured the nicotine absorption of the four variants of nicotine pouch (NP-1; NP-2; NP-3; NP-4) together with two nicotine pouches marketed by other companies (Zyn-NP and Velo-NP). Participants were also asked to evaluate their experience of using the nicotine pouches. Who participated in the study? The study recruited 31 healthy, male or female, adults aged between 21 and 65 years who were currently smoking. The subjects did not plan to quit using tobacco and/or nicotine products within the next 3 months and had smoked continuously for at least the last 3 years prior to joining the study.. Each subject was given full and adequate oral and written information about the nature, purpose, possible risks and benefits of the study. Once each subject had received all the necessary information, and if he/she agreed to participate, this was documented in an Informed Consent Form with the date, time and signature of both the subject and the Investigator. Subjects were informed that they were free to withdraw from the study at any time. What treatments or interventions did the participants take/receive? The participants were requested to use a tobacco-free nicotine pouch for a period of 30 minutes. Blood samples were taken before, during, and after the product use period. Participants were also asked to evaluate their experience of using the nicotine pouches, using the Product Evaluation Scale (PES). The PES is composed of seven items which address the degree to which subjects experience seven different effects (Product Satisfaction, Psychological Rewards, Aversion, Craving Relief, Easy to Use, Comfortable Using, Concerned about Dependence) as a result of using the investigational products, rated on a 7 point scale from 1 = not at all to 7 = extremely. What happened during the study? The study was conducted with six periods and six sequences in a cross-over design. On Day -1, subjects were randomized to one of the six study sequences. After enrollment, subjects performed a product test with Nicotine Pouch 1.0 (NP-1) for 30 minutes (± 1 minute). One NP-1 nicotine pouch was placed between the upper lip and the gum for 30 minutes and subjects were instructed not to manipulate the pouch with the tongue or lips. After the product test, subjects were required to abstain from any nicotine/tobacco-containing product use until the first product use on Day 1. On Day 1 to Day 3, after at least 8 hours of abstinence from any nicotine/tobacco-containing products (nicotine wash-out), subjects used one variant of NP 1.0, Velo-NP, or Zyn-NP according to the randomized product use sequence for 30 minutes (± 1 minute). The used NP were collected for long-term storage to determine the residual nicotine after product use to estimate the amount of nicotine delivered during the 30-minute use period. Subjects completed questionnaires about product evaluation, craving, and liking assessments. In the morning on Day 1, 12 blood samples were collected for determination of nicotine concentration. Additional blood samples were taken for determination of the nicotine concentration on Day 2 and Day 3. After Discharge at Day 3, the subjects entered a 3-day Safety Follow-Up period during which adverse reactions associated with product use reported by the subjects were collected and the follow-up of any ongoing adverse reactions was conducted by the study investigational site.

Interventions

OTHERNP-1

NP-1; 8.4 mg nicotine; pH 8.0; moisture 30

OTHERNP-2

NP-2; 8.4 mg nicotine; pH 9.0; moisture 30

OTHERNP-3

NP-3; 3.6 mg nicotine; pH 8.0; moisture 15

OTHERNP-4

NP-4; 3.6 mg nicotine; pH 8.0; moisture 30

OTHERVelo-NP

Velo-NP; 10 mg nicotine;

OTHERZyn-NP

Zyn-NP; 3 mg nicotine;

Sponsors

Philip Morris Products S.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Main Inclusion Criteria: * Subject has smoked continuously for at least the last 3 years prior to the Screening visit. * Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL). * Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months. * Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period. Main

Exclusion criteria

* As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical. * Subject is legally incompetent, or physically or mentally incapable of giving consent. * Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject. * Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit. * Subject has a BMI \< 18.5 kg/m2 or \> 32.0 kg/m2 (Europe) or \> 35.0 kg/m2 (USA). * For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
Background-corrected Maximum Plasma Concentration [Cmax]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.
Background-corrected Time to the Maximum Concentration [Tmax]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.
Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)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.

Secondary

MeasureTime frameDescription
Score of Product Satisfaction by the VAS-satisfaction AssessmentMeasured 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.
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentMeasured 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.
Score of Product Intention to Use Again by the VAS-intention to Use Again AssessmentMeasured 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.
Score of in the Moment Product Liking by the VAS-liking AssessmentMeasured 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.
Score of Overall Product Liking by the VAS-liking AssessmentMeasured 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.

Countries

United Kingdom

Participant flow

Recruitment details

31 subjects were enrolled in the study, which was conducted at a clinical trial facility managed by a contract research organization.

Pre-assignment details

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.

Participants by arm

ArmCount
Safety Population
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).
31
Total31

Withdrawals & dropouts

PeriodReasonFG000
AdmissionWithdrawal by Subject2
RandomizationDiscontinued6
RandomizationWithdrawal by Subject1

Baseline characteristics

CharacteristicSafety Population
Age, Continuous40.6 years
STANDARD_DEVIATION 9.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Fagerström score5.2 units on a scale
STANDARD_DEVIATION 1.59
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
31 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 220 / 220 / 220 / 220 / 230 / 24
other
Total, other adverse events
0 / 310 / 220 / 220 / 220 / 220 / 230 / 24
serious
Total, serious adverse events
0 / 310 / 220 / 220 / 220 / 220 / 230 / 24

Outcome results

Primary

Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)

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.

Time frame: 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).

ArmMeasureValue (MEAN)
NP-1Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)128.2 min*ng/mL
NP-2Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)217.3 min*ng/mL
NP-3Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)41.35 min*ng/mL
NP-4Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)49.30 min*ng/mL
Velo-NPArea Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)201.3 min*ng/mL
Zyn-NPArea Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)136.0 min*ng/mL
Primary

Background-corrected Maximum Plasma Concentration [Cmax]

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.

Time frame: 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).

ArmMeasureValue (MEAN)
NP-1Background-corrected Maximum Plasma Concentration [Cmax]8.109 ng/mL
NP-2Background-corrected Maximum Plasma Concentration [Cmax]11.48 ng/mL
NP-3Background-corrected Maximum Plasma Concentration [Cmax]2.629 ng/mL
NP-4Background-corrected Maximum Plasma Concentration [Cmax]3.464 ng/mL
Velo-NPBackground-corrected Maximum Plasma Concentration [Cmax]11.32 ng/mL
Zyn-NPBackground-corrected Maximum Plasma Concentration [Cmax]9.257 ng/mL
Primary

Background-corrected Time to the Maximum Concentration [Tmax]

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.

Time frame: 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).

ArmMeasureValue (MEDIAN)
NP-1Background-corrected Time to the Maximum Concentration [Tmax]35.70 minutes
NP-2Background-corrected Time to the Maximum Concentration [Tmax]34.80 minutes
NP-3Background-corrected Time to the Maximum Concentration [Tmax]34.89 minutes
NP-4Background-corrected Time to the Maximum Concentration [Tmax]34.98 minutes
Velo-NPBackground-corrected Time to the Maximum Concentration [Tmax]33.99 minutes
Zyn-NPBackground-corrected Time to the Maximum Concentration [Tmax]34.95 minutes
Secondary

Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment

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.

Time frame: Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

ArmMeasureGroupValue (MEAN)
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use29.0 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use61.0 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use27.2 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use58.3 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use36.4 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use45.8 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use27.3 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use29.2 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use26.8 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use29.1 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use38.5 score on a scale
NP-1Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use28.8 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use28.6 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use28.3 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use29.5 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use38.1 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use31.7 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use29.9 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use62.6 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use27.1 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use52.8 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use33.8 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use60.1 score on a scale
NP-2Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use32.0 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use53.9 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use43.0 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use34.6 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use39.5 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use64.2 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use44.9 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use37.2 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use36.9 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use38.0 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use50.3 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use64.3 score on a scale
NP-3Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use46.1 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use33.7 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use67.4 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use42.6 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use38.6 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use36.5 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use36.4 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use35.8 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use35.4 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use33.5 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use35.8 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use51.5 score on a scale
NP-4Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use57.8 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use26.9 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use34.3 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use68.6 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use57.0 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use42.1 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use31.7 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use38.7 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use22.8 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use24.3 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use24.2 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use23.4 score on a scale
Velo-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use24.1 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment35 min Post-Product Use19.5 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment20 min Post-Product Use22.7 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment40 min Post-Product Use21.1 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment15 min Post-Product Use26.9 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment6 hr Post-Product Use54.2 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment1 hr Post-Product Use24.7 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment10 min Post-Product Use29.0 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment5 min Post-Product Use39.4 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment3 hr Post-Product Use48.4 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentPre-Product Use68.9 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment30 min Post-Product Use19.5 score on a scale
Zyn-NPScore of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment25 min Post-Product Use20.0 score on a scale
Secondary

Score of in the Moment Product Liking by the VAS-liking Assessment

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.

Time frame: Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

ArmMeasureGroupValue (MEAN)
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use49.7 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use55.2 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use54.6 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use60.0 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use54.8 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use56.7 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use59.2 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use54.7 score on a scale
NP-1Score of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use51.5 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use55.8 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use53.8 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use56.5 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use54.5 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use54.2 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use53.5 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use57.2 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use54.0 score on a scale
NP-2Score of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use56.2 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use51.4 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use51.4 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use52.0 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use52.1 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use52.4 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use52.1 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use51.4 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use50.1 score on a scale
NP-3Score of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use49.8 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use52.1 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use53.4 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use53.6 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use52.7 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use54.5 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use52.7 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use48.2 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use51.7 score on a scale
NP-4Score of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use54.0 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use57.7 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use54.7 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use58.7 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use57.2 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use57.0 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use56.1 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use55.8 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use55.6 score on a scale
Velo-NPScore of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use51.7 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment1 hr Post-Product Use58.2 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment5 min Post-Product Use60.2 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment10 min Post-Product Use60.6 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment20 min Post-Product Use60.3 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment25 min Post-Product Use61.6 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment30 min Post-Product Use59.9 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment35 min Post-Product Use59.4 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment40 min Post-Product Use58.7 score on a scale
Zyn-NPScore of in the Moment Product Liking by the VAS-liking Assessment15 min Post-Product Use58.7 score on a scale
Secondary

Score of Overall Product Liking by the VAS-liking Assessment

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.

Time frame: Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

ArmMeasureValue (MEAN)
NP-1Score of Overall Product Liking by the VAS-liking Assessment56.5 score on a scale
NP-2Score of Overall Product Liking by the VAS-liking Assessment53.2 score on a scale
NP-3Score of Overall Product Liking by the VAS-liking Assessment49.0 score on a scale
NP-4Score of Overall Product Liking by the VAS-liking Assessment49.5 score on a scale
Velo-NPScore of Overall Product Liking by the VAS-liking Assessment49.9 score on a scale
Zyn-NPScore of Overall Product Liking by the VAS-liking Assessment52.3 score on a scale
Secondary

Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment

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.

Time frame: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

ArmMeasureGroupValue (MEAN)
NP-1Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use51.3 score on a scale
NP-1Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use48.8 score on a scale
NP-2Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use52.0 score on a scale
NP-2Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use48.1 score on a scale
NP-3Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use46.7 score on a scale
NP-3Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use51.6 score on a scale
NP-4Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use48.3 score on a scale
NP-4Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use44.5 score on a scale
Velo-NPScore of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use55.3 score on a scale
Velo-NPScore of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use50.9 score on a scale
Zyn-NPScore of Product Intention to Use Again by the VAS-intention to Use Again Assessment30 min Post-Product Use57.9 score on a scale
Zyn-NPScore of Product Intention to Use Again by the VAS-intention to Use Again Assessment3 hr Post-Product Use49.5 score on a scale
Secondary

Score of Product Satisfaction by the VAS-satisfaction Assessment

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.

Time frame: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

ArmMeasureGroupValue (MEAN)
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use54.2 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use54.2 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use60.9 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use58.0 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use52.5 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use60.6 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use59.0 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use32.6 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use61.1 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use46.2 score on a scale
NP-1Score of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use61.2 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use26.7 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use58.2 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use56.8 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use37.3 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use57.4 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use51.5 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use52.6 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use57.9 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use53.2 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use56.0 score on a scale
NP-2Score of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use52.0 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use36.9 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use45.8 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use48.2 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use50.5 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use49.7 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use50.1 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use50.4 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use46.0 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use44.4 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use43.5 score on a scale
NP-3Score of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use33.6 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use49.5 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use49.3 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use51.7 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use37.3 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use50.3 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use33.2 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use50.2 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use52.9 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use50.2 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use50.0 score on a scale
NP-4Score of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use50.8 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use48.4 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use61.6 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use60.4 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use57.5 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use29.2 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use61.4 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use54.5 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use57.9 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use44.4 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use58.2 score on a scale
Velo-NPScore of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use61.0 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment35 min Post-Product Use65.1 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment5 min Post-Product Use55.8 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment6 hr Post-Product Use35.4 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment15 min Post-Product Use62.4 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment25 min Post-Product Use67.5 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment3 hr Post-Product Use38.1 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment20 min Post-Product Use65.2 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment10 min Post-Product Use62.0 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment40 min Post-Product Use60.5 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment30 min Post-Product Use67.3 score on a scale
Zyn-NPScore of Product Satisfaction by the VAS-satisfaction Assessment1 hr Post-Product Use59.5 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026