SmokingNCT02643693

User Acceptability of a Nicotine Lactate Delivery System (P3L)

A study testing P3L, VUSE and CC in people with Smoking, run by Philip Morris Products S.A. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette… Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: P3L, VUSE and CC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Dec 2016
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 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Smoking, healthy subject as judged by the Investigator
Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months
Subject does not plan to quit smoking in the next 60 days

Who cannot join

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
Subject has donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit
Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit
Female subject is pregnant or breast feeding
Female subject does not agree to use an acceptable method of effective contraception
Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Rose Research Center, LLC
Raleigh, North Carolina, 27617

Other trials in United States

About this study

Official title: User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators

Read the detailed description

The total duration of the study for an individual subject will be between 3 and 8 weeks, including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the preference evaluation session (subjects will be given the choice of using ad libitum the P3L or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive safety follow-up period.

The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.

Conditions: Smoking
Being tested: P3L, VUSE, CC
Keywords: Conventional cigarette, Nicotine lactate delivery system, e-cigarette, VUSE, Combustible cigarette
Medical subject headings: Smoking, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P3LOther
Ad libitum use for a maximum of three hours.
P3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime.
VUSEOther
Ad libitum use for a maximum of three hours.
VUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime.
CCOther
Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.

Study groups in NCT02643693
Study group	Role	What they receive
P3L Product use	Experimental	Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). Receives: Other: P3L
VUSE Product Use	Experimental	Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). Receives: Other: VUSE
CC Product Use	Experimental	Subject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC). Receives: Other: CC

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).
Measured: Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC).
Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.
Products were compared over all timepoints using a repeated measure model using values after t0.
The model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated.
Measured: QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Dec 2016

First posted31 Dec 2015 (estimated)
Study startNov 2015
Primary completionMay 2016
Study completionDec 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643693
Sponsor's protocol ID: P3L-PK-02-US
Status last verified: Jul 2019
First submitted: 17 Dec 2015
Last updated: 1 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.
PubMed 11260806

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
ClinicalTrials.gov ID: NCT02643693
Acronym / sponsor ID: P3L-PK-02-US
Conditions: Smoking
Keywords: Conventional cigarette, Nicotine lactate delivery system, e-cigarette, VUSE, Combustible cigarette
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: May 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
P3L Product use	Experimental	Other: P3LSubject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
VUSE Product Use	Experimental	Other: VUSESubject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).
CC Product Use	Experimental	Other: CCSubject product use was randomly assigned for each ad libitum use session, following a sequence of product exposure comprised of the three products (P3L, VUSE, and CC).

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Smoking, healthy subject as judged by the Investigator
Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months
Subject does not plan to quit smoking in the next 60 days

Key exclusion criteria (6 listed)

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
Subject has donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit
Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit
Female subject is pregnant or breast feeding
Female subject does not agree to use an acceptable method of effective contraception

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
P3LAd libitum use for a maximum of three hours. P3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime.	Other	P3L Product use
VUSEAd libitum use for a maximum of three hours. VUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime.	Other	VUSE Product Use
CCAd libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.	Other	CC Product Use

Primary outcome

Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
Time frame: Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.
For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).
Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
Time frame: QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.
The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC). Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Products were compared over all timepoints using a repeated measure model using values after t0. The model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated.

Results and safety

Results posted to the registry on 20 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P3L/Vuse/CC Product Exposure	4	2
P3L/CC/Vuse Product Exposure	4	2
Vuse/CC/P3L Product Exposure	4	3
Vuse/P3L/CC Product Exposure	4	4
CC/P3L/Vuse Product Exposure	4	4
CC/Vuse/P3L Product Exposure	4	3

Primary outcome: Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.

Time frame: Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.. Geometric mean (95% Confidence Interval). Unit: (ng/mL)

Measure	P3L Product Exposure n = 16	VUSE Product Exposure n = 16	CC Product Exposure n = 16
Baseline (Average) before session: Nicotine	1.7621 (1.1308 to 2.7459)	2.4113 (1.8529 to 3.1378)	1.9446 (1.5375 to 2.4594)
Change from Baseline after session: Nicotine	5.5571 (3.5802 to 8.6255)	7.3425 (4.7138 to 11.4371)	17.1821 (13.7633 to 21.4500)
Baseline (Average) before session: Cotinine	182.554 (148.073 to 225.065)	187.559 (147.914 to 237.828)	199.547 (161.636 to 246.351)
Change from Baseline after session: Cotinine	15.222 (10.116 to 22.905)	11.163 (5.523 to 22.561)	33.888 (24.004 to 47.842)

Population analysed: All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.

Primary outcome: Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)

Time frame: QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	P3L Product Exposure n = 16	VUSE Product Exposure n = 16	CC Product Exposure n = 16
Total Score - Over all timepoints	3.86 (3.36 to 4.36)	3.08 (2.58 to 3.58)	1.93 (1.43 to 2.42)
Total Score - t0 + 60mins	4.02 (3.51 to 4.52)	3.24 (2.74 to 3.74)	2.09 (1.58 to 2.59)
Total Score - t0 + 120mins	3.84 (3.33 to 4.36)	3.07 (2.56 to 3.58)	1.91 (1.40 to 2.42)
Total Score - t0 + 180mins	3.71 (3.20 to 4.23)	2.94 (2.42 to 3.45)	1.78 (1.27 to 2.29)
Factor 1 - Over all timepoints	4.97 (4.39 to 5.54)	4.11 (3.54 to 4.68)	2.15 (1.58 to 2.73)
Factor 1 - t0 + 60mins	4.87 (4.28 to 5.46)	4.48 (3.89 to 5.06)	2.53 (1.94 to 3.12)
Factor 1 - t0 + 120mins	4.99 (4.33 to 5.64)	4.11 (3.46 to 4.77)	2.08 (1.42 to 2.74)
Factor 1 - t0 + 180mins	5.05 (4.43 to 5.66)	3.74 (3.13 to 4.35)	1.84 (1.23 to 2.46)

Population analysed: All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.

Adverse events

Time frame: Adverse events were collected over the entire study duration of up to 5 months, with individual subject participation of between three and 11 weeks from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P3L Product	0 of 21 (0%)	14 of 21 (66.7%)	0 of 21
VUSE Product	0 of 19 (0%)	13 of 19 (68.4%)	0 of 19
CC Product	0 of 19 (0%)	9 of 19 (47.4%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11260806Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.
Individual participant dataSharing planned: No

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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.

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

Jed E. Rose, PhD principal investigator

Rose Research Center, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing P3L, VUSE and CC in people with Smoking, run by Philip Morris Products S.A. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. 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 1 Aug 2019. 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 States. 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 20 Jun 2019). 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?

Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session. (time frame: Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02643693, which also lists 1 linked publication.

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 1 Aug 2019.