CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting

Summary

This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to one of two different ENDS, Product A with 1.5% nicotine, and Product B with 3.0% nicotine, over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

OTHER

CSD190601-11

Flavor variant CSD190601-11 of a 1.5% nicotine ENDS product

OTHER

CSD190601-12

Flavor variant CSD190601-12 of a 1.5% nicotine ENDS product

OTHER

CSD190601-13

Flavor variant CSD190601-13 of a 1.5% nicotine ENDS product

OTHER

CSD190601-14

Flavor variant CSD190601-14 of a 1.5% nicotine ENDS product

OTHER

CSD190601-15

Flavor variant CSD190601-15 of a 1.5% nicotine ENDS product

OTHER

CSD190601-16

Flavor variant CSD190601-16 of a 1.5% nicotine ENDS product

OTHER

CSD190601-17

Flavor variant CSD190601-17 of a 1.5% nicotine ENDS product

OTHER

CSD190601-21

Flavor variant CSD190601-21 of a 3.0% nicotine ENDS product

OTHER

CSD190601-22

Flavor variant CSD190601-22 of a 3.0% nicotine ENDS product

OTHER

CSD190601-23

Flavor variant CSD190601-23 of a 3.0% nicotine ENDS product

OTHER

CSD190601-24

Flavor variant CSD190601-24 of a 3.0% nicotine ENDS product

OTHER

CSD190601-25

Flavor variant CSD190601-25 of a 3.0% nicotine ENDS product

OTHER

CSD190601-26

Flavor variant CSD190601-26 of a 3.0% nicotine ENDS product

OTHER

CSD190601-27

Flavor variant CSD190601-27 of a 3.0% nicotine ENDS product

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Gary Dull, PhD · RAIS

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-26

Primary Completion

2020-10-22

Completion

2020-10-22

Countries

• United States

Study Locations