CSD201203: A Study to Determine Subject Puffing Patterns of a Non-cylindrical, Closed, Electronic Nicotine Delivery System at Three Nicotine Concentrations in an Ambulatory Setting
NCT05118139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2025-04-10
Summary
This is a multi-center, open-label, parallel, three-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 the ENDS Investigational Product (IP), over a 9-day ambulatory period.
Conditions
- Smoking
- Tobacco Use
- Electronic Cigarette Use
Interventions
- OTHER
-
P1211216
Flavor variant P1211216 of a 1.5% nicotine ENDS product
- OTHER
-
P1213416
Flavor variant P1213416 of a 1.5% nicotine ENDS product
- OTHER
-
P1213716
Flavor variant P1213716 of a 1.5% nicotine ENDS product
- OTHER
-
P1213616
Flavor variant P1213616 of a 1.5% nicotine ENDS product
- OTHER
-
P1213816
Flavor variant P1213816 of a 1.5% nicotine ENDS product
- OTHER
-
P1211916
Flavor variant P1211916 of a 1.5% nicotine ENDS product
- OTHER
-
P1210016
Flavor variant P1210016 of a 1.5% nicotine ENDS product
- OTHER
-
P1211217
Flavor variant P1211217 of a 2.4% nicotine ENDS product
- OTHER
-
P1213417
Flavor variant P1213417 of a 2.4% nicotine ENDS product
- OTHER
-
P1211222
Flavor variant P1211222 of a 5% nicotine ENDS product
- OTHER
-
P1213422
Flavor variant P1213422 of a 5% nicotine ENDS product
- OTHER
-
P1213722
Flavor variant P1213722 of a 5% nicotine ENDS product
- OTHER
-
P1213622
Flavor variant P1213622 of a 5% nicotine ENDS product
- OTHER
-
P1213822
Flavor variant P1213822 of a 5% nicotine ENDS product
- OTHER
-
P1211922
Flavor variant P1211922 of a 5% nicotine ENDS product
- OTHER
-
P1210022
Flavor variant P1210022 of a 5% 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
- 2022-02-11
- Primary Completion
- 2022-07-30
- Completion
- 2022-07-30
Countries
- United States
Study Locations
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