CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers

Summary

The purpose of this Actual Use Study (AUS) is to investigate how United States (US) adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day on at least 20 of the past 30 days) will use the Cartridge-based ENDS investigational products (Study IP) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environments. Subjects will be able to choose freely among the Study IP available in one of the three study arms to which they are randomly assigned. The three study arms are organized by Study IP flavor categories: tobacco, menthol, and non-tobacco-non-menthol (NTNM). Subjects will self-report their ad libitum use of the Study IP as well as use of Combustible Cigarettes (CC) and any other tobacco- and nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary).

Conditions

• Smoking, Tobacco

Interventions

OTHER

P1213416

Tobacco Flavor

OTHER

P1213422

Tobacco Flavor

OTHER

P1213716

Tobacco Flavor

OTHER

P1213722

Tobacco Flavor

OTHER

P1211216

Menthol Flavor

OTHER

P1211222

Menthol Flavor

OTHER

P1213616

Menthol Flavor

OTHER

P1213622

Menthol Flavor

OTHER

P1213816

NTNM Flavor

OTHER

P1213822

NTNM Flavor

OTHER

P1211916

NTNM Flavor

OTHER

P1211922

NTNM Flavor

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Kristen Jordan, PhD · RAIS

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-15

Primary Completion

2024-01-22

Completion

2024-01-28

Countries

• United States

Study Locations