Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 10:35 PM
Study NCT ID:
NCT04226404
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility and, based on meeting eligibility requirements, will be enrolled into the study on the same day of the Screening Visit.
Once enrolled, the subjects will be assigned to one of the seven flavor variants of ENDS product. Subjects will be allowed to sample flavors and determine which flavor that they would like to use for the length of the study. Subjects will then participate in a three-week ambulatory study in which they will use their assigned IP in place of their UB ENDS. Subjects will be directed to not use their UB ENDS products during the study.
At the initial visit, subjects will be provided an orientation to the product, including the IP power unit, cartridges, the Product Use and Behavior (PUB) instrument, PUB application, and a provided electronic device. Based upon their UB ENDS usage, they will be given a sufficient amount (for three weeks of ad libitum use equaling 375% of their self-reported UB weekly use) of ENDS cartridges. The study will involve a one-week acclimation period followed by a two-week product use evaluation period. At the end of the first week of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. The PUB instrument will collect topography data, and product use data will be uploaded frequently using a web-based PUB application installed on the electronic device provided by the Sponsor. Throughout the study, subjects will receive weekly phone calls to remind them of guidelines for using their assigned IP. Subjects will be instructed to use the IP in place of their UB ENDS, but they will be allowed to use non-ENDS tobacco/nicotine-containing products according to their normal use pattern. All used cartridges may be disposed of by the subject.
At the conclusion of the three-week ambulatory period, subjects will return to the clinic; return the IP power unit, charger, all unused cartridges, the PUB instrument (and all cables/charger), and the provided electronic device. Each subject will complete all End of Study procedures, including completing the Product Evaluation Scale (PES) questionnaire, and they will then be discharged from the study.
Once enrolled, the subjects will be assigned to one of the seven flavor variants of ENDS product. Subjects will be allowed to sample flavors and determine which flavor that they would like to use for the length of the study. Subjects will then participate in a three-week ambulatory study in which they will use their assigned IP in place of their UB ENDS. Subjects will be directed to not use their UB ENDS products during the study.
At the initial visit, subjects will be provided an orientation to the product, including the IP power unit, cartridges, the Product Use and Behavior (PUB) instrument, PUB application, and a provided electronic device. Based upon their UB ENDS usage, they will be given a sufficient amount (for three weeks of ad libitum use equaling 375% of their self-reported UB weekly use) of ENDS cartridges. The study will involve a one-week acclimation period followed by a two-week product use evaluation period. At the end of the first week of the study, subjects will receive a phone call from the clinic to assess IP compliance and to ensure that they are not using their UB ENDS. The PUB instrument will collect topography data, and product use data will be uploaded frequently using a web-based PUB application installed on the electronic device provided by the Sponsor. Throughout the study, subjects will receive weekly phone calls to remind them of guidelines for using their assigned IP. Subjects will be instructed to use the IP in place of their UB ENDS, but they will be allowed to use non-ENDS tobacco/nicotine-containing products according to their normal use pattern. All used cartridges may be disposed of by the subject.
At the conclusion of the three-week ambulatory period, subjects will return to the clinic; return the IP power unit, charger, all unused cartridges, the PUB instrument (and all cables/charger), and the provided electronic device. Each subject will complete all End of Study procedures, including completing the Product Evaluation Scale (PES) questionnaire, and they will then be discharged from the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: