Clinical Trial

Puffing Patterns of an Electronic Nicotine Delivery System

Study Description

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

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).

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

CSD1905-11

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

CSD1905-12

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

CSD1905-13

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

CSD1905-14

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

CSD1905-15

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

CSD1905-16

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

CSD1905-17

Flavor variant CSD1905-17 of a 4.8% nicotine ENDS product

Additional Information

Official Study Title

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

Clinical Trial ID

NCT04226404

ParticipAid ID

aADR1e