Clinical Trial

Puffing Patterns of an Electronic Nicotine Delivery System

Study Description

CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).

Location

Locations Selected Location

Methods

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

CSD1902-11

A 2.4% nicotine ENDS product

CSD1902-12

A 2.4% nicotine ENDS product

CSD1902-13

A 2.4% nicotine ENDS product

CSD1902-14

A 2.4% nicotine ENDS product

CSD1902-21

A 5.0% nicotine ENDS product

CSD1902-22

A 5.0% nicotine ENDS product

CSD1902-23

A 5.0% nicotine ENDS product

CSD1902-24

A 5.0% nicotine ENDS product

Additional Information

Official Study Title

CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Clinical Trial ID

NCT04104152

ParticipAid ID

dR6Nqd