CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
P3L +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02643693
NCT02643693N/ACompleted
CompareCT.gov

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

Philip Morris Products S.A.·interventional·Posted Dec 31, 2015·Updated Aug 1, 2019

In Brief

A clinical study evaluating P3L, VUSE, and 1 other intervention for Smoking. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 31, 2015
Enrollment StartNov 1, 2015
Primary CompletionMay 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.5 years ago

Interventions

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.