SmokingNCT05317195
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 study testing NP-1, NP-2 and NP-3 in people with Smoking and Nicotine, run by Philip Morris Products S.A. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- What is being tested?
- NP-1, NP-2 and NP-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2022to 18 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the 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.
- Being tested
- NP-1, NP-2, NP-3, NP-4, Velo-NP
- Keywords
- Nicotine-containing products, Nicotine delivery
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-1Other
NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
NP-2Other
NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
NP-3Other
NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
NP-4Other
NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
Velo-NPOther
Velo-NP; 10 mg nicotine;
Zyn-NPOther
Zyn-NP; 3 mg nicotine;
| Study group | Role | What they receive |
|---|---|---|
| NP-1 | Experimental | Nicotine Pouch 1.0 (variant NP-1) Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
| NP-2 | Experimental | Nicotine Pouch 1.0 (variant NP-2) Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
| NP-3 | Experimental | Nicotine Pouch 1.0 (variant NP-3) Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
| NP-4 | Experimental | Nicotine Pouch 1.0 (variant NP-4) Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
| Velo-NP | Active comparator | Velo® Ice Cool Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
| Zyn-NP | Active comparator | Zyn® Cool Mint Mini Dry Receives: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Secondary outcomes (5)
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.
Measured: Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
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.
Measured: Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
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.
Measured: Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
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.
Measured: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
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.
Measured: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Mar 2022
- Primary completion7 May 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajkumar Chetty, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317195
- Sponsor's protocol ID
- P5-PK-01-EXP
- Status last verified
- Sep 2024
- First submitted
- 30 Mar 2022
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05317195
- Acronym / sponsor ID
- P5-PK-01-EXP
- Keywords
- Nicotine-containing products, Nicotine delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NP-1 | Experimental | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPNicotine Pouch 1.0 (variant NP-1) |
| NP-2 | Experimental | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPNicotine Pouch 1.0 (variant NP-2) |
| NP-3 | Experimental | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPNicotine Pouch 1.0 (variant NP-3) |
| NP-4 | Experimental | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPNicotine Pouch 1.0 (variant NP-4) |
| Velo-NP | Active comparator | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPVelo® Ice Cool |
| Zyn-NP | Active comparator | Other: NP-1, Other: NP-2, Other: NP-3, Other: NP-4, Other: Velo-NP, Other: Zyn-NPZyn® Cool Mint Mini Dry |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP-1NP-1; 8.4 mg nicotine; pH 8.0; moisture 30 | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
| NP-2NP-2; 8.4 mg nicotine; pH 9.0; moisture 30 | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
| NP-3NP-3; 3.6 mg nicotine; pH 8.0; moisture 15 | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
| NP-4NP-4; 3.6 mg nicotine; pH 8.0; moisture 30 | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
| Velo-NPVelo-NP; 10 mg nicotine; | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
| Zyn-NPZyn-NP; 3 mg nicotine; | Other | NP-1, NP-2, NP-3, NP-4, Velo-NP, Zyn-NP |
Primary outcome
Background-corrected Maximum Plasma Concentration [Cmax]
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).
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]
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).
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)
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).
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.
5 secondary outcomes
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment
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)
Score of "in the Moment" Product Liking by the VAS-liking Assessment
Time frame: Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
Score of Overall Product Liking by the VAS-liking Assessment
Time frame: Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
Score of Product Satisfaction by the VAS-satisfaction Assessment
Time frame: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment
Time frame: Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajkumar Chetty, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NP-1, NP-2 and NP-3 in people with Smoking and Nicotine, run by Philip Morris Products S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Background-corrected Maximum Plasma Concentration [Cmax] (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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.