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User Acceptability of a Nicotine Lactate Delivery System (P3L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02643693
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : June 20, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief 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 system.

Condition or disease Intervention/treatment Phase
Smoking Other: P3L Other: VUSE Other: CC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: P3L Product use
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).
Other: P3L

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.


Experimental: VUSE Product Use
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).
Other: VUSE

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.


Experimental: CC Product Use
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).
Other: CC
Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.




Primary Outcome Measures :
  1. 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).

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643693


Locations
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United States, North Carolina
Rose Research Center, LLC
Raleigh, North Carolina, United States, 27617
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Jed E. Rose, PhD Rose Research Center, LLC

Publications:
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02643693    
Other Study ID Numbers: P3L-PK-02-US
First Posted: December 31, 2015    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
Conventional cigarette
Nicotine lactate delivery system
e-cigarette
VUSE
Combustible cigarette
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action