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User Acceptability of a Nicotine Lactate Delivery System (P3L)

Smoking Clinical Trial

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

Clinical 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 system.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02643693
Study type Interventional
Source Philip Morris Products S.A.
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date December 2016
View Details
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