NCT02643693

User Acceptability of a Nicotine Lactate Delivery System (P3L)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking

Interventions

Type	Name	Description
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.
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.
OTHER	CC	Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-05-01
• Completion: 2016-12-01
• First posted: 2015-12-31
• Last updated: 2019-08-01
• Results posted: 2019-06-20

Locations

1 site across 1 country: United States