Clinical trial NCT02643693: User Acceptability of a Nicotine Lactate Delivery System (P3L)
Official title: User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Conventional cigarette
Nicotine lactate delivery system
e-cigarette
VUSE
Combustible cigarette
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2015-12-31
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.
timeFrame: 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.
measure: Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)
timeFrame: QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Rose Research Center, LLC
state: North Carolina
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Rose Research Center, LLC
name: Jed E. Rose, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.