CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Summary

This study will be a single-center, controlled, open-label, parallel study 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 an ENDS Investigational Product (IP) product with 4.8% 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

CSD1905-11

Flavor variant CSD1905-11 of a 4.8% nicotine ENDS product

OTHER

CSD1905-12

Flavor variant CSD1905-12 of a 4.8% nicotine ENDS product

OTHER

CSD1905-13

Flavor variant CSD1905-13 of a 4.8% nicotine ENDS product

OTHER

CSD1905-14

Flavor variant CSD1905-14 of a 4.8% nicotine ENDS product

OTHER

CSD1905-15

Flavor variant CSD1905-15 of a 4.8% nicotine ENDS product

OTHER

CSD1905-16

Flavor variant CSD1905-16 of a 4.8% nicotine ENDS product

OTHER

CSD1905-17

Flavor variant CSD1905-17 of a 4.8% 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

2020-01-14

Primary Completion

2020-02-27

Completion

2020-02-27

Countries

• United States

Study Locations