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User Acceptability of a Nicotine Lactate Delivery System (P3L)

NCT02643693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-08-01

Study results available
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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.

Conditions

  • Smoking

Interventions

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.

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products S.A.

  • Jed E. Rose, PhD · Rose Research Center, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-05-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643693 on ClinicalTrials.gov