Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05960305 |
| Other study ID # |
CSD201204 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2023 |
| Est. completion date |
January 28, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
RAI Services Company |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this Actual Use Study (AUS) is to investigate how United States (US) adult
tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5
cigarettes/day on at least 20 of the past 30 days) will use the Cartridge-based ENDS
investigational products (Study IP) over a 6-week Actual Use Period (AUP) in their
real-life/naturalistic environments. Subjects will be able to choose freely among the Study
IP available in one of the three study arms to which they are randomly assigned. The three
study arms are organized by Study IP flavor categories: tobacco, menthol, and
non-tobacco-non-menthol (NTNM). Subjects will self-report their ad libitum use of the Study
IP as well as use of Combustible Cigarettes (CC) and any other tobacco- and
nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary).
Description:
The AUS is a multi-site, open-label, randomized, three-arm, 8-week, prospective observational
study to be conducted at multiple sites geographically dispersed within the U.S.. Adult
tobacco consumers 21 to 60 years of age (inclusive) who smoked on at least 20 of the past 30
days and smoked at least 5 CPD on the days they smoked will be provided the Study IP for ad
libitum use over a 6-week Actual Use Period (AUP) in their real-life/naturalistic
environments. Subject-reported consumption of the Study IP, Combustible cigarettes, and other
TNPs will be assessed (including, but not limited to, ENDS, smokeless tobacco, and other
combustible tobacco products).
The study includes pre-screening, a screening and enrollment visit (SEV), a baseline
assessment period (BAP), an observational actual use period (AUP), and a close out period
(COP). Following the recruitment period, the study duration per enrolled subject will be
approximately eight (8) weeks. Following the administration of a Baseline Assessment
Questionnaire (BAQ) at the SEV, use of Combustible Cigarettes and other TNP will be
self-reported using an eDiary during the 1-week BAP.
At SEV, subjects will be asked to indicate their likelihood to use each Study IP flavor
variant across the three study arms. Subjects who indicate an interest in using at least one
of the two flavors per arm for all three arms will be enrolled into the study and randomized
into one of the three arms prior to completion of BAQ.
The Study IP evaluated in this study will include the Power Unit and 12 cartridge variants
(six flavor variants in two nicotine concentrations, 1.5% and 5%). In each arm, four variants
(two flavor variants in two nicotine concentrations) will be available for choice. Subjects
will be shown the Study IP (power unit, charging cord and all 12 flavor cartridges), user
guide and handout marketing materials (MM) at SEV prior to study arm assignment. MM (poster)
of Study IP in all three arms will be present at SEV and only arm-specific MM will be present
at all subsequent site visits. Subjects will be first dispensed the power unit and preferred
Study IP variants (i.e., specific flavor and nicotine concentrations) available within their
assigned study arm during SV1 and a handout MM will be given to the subjects to take home at
SV1.
Starting at SV1, enrolled subjects will be able to select Study IP for use during the AUP
from the Study IP available in their assigned study arm. Subjects will be instructed not to
use ENDS other than the Study IP provided by the study site for the duration of the AUP in
the ICF. However, if subjects report other ENDS use in the eDiary, this will not lead to
study discontinuation. Subjects can use the Study IP and other TNP including Combustible
Cigarettes ad libitum during the AUP and will self-report product use on a daily basis via an
eDiary over the 6-week AUP. Throughout the AUP, a toll-free Hotline will be available for
subjects to report potential product-related adverse health experiences, pregnancy, and/or
product quality complaints.
Subjects will return to the study site three additional times (SV2, SV3, and SV4) for an
interview to review eDiary compliance, complete additional questionnaires, return unused
Study IP, and receive additional Study IP (SV2 and SV3, as needed). At SV4, subjects will
complete an End of Study Questionnaire (ESQ). The COP will allow for reporting study queries
to the sites, along with possible adverse health experiences to the toll-free Hotline after
SV4.
Subjects will be presented with hard-copy marketing material (MM) at the SEV for all Study IP
variants in all three study arms. Consistent with typical consumer marketing practices,
representative point of sale (POS) MM will be present during subject interactions at the SEV
and SVs (e.g., product poster). At SV1-SV4, enrolled subjects will only be exposed to MM
relating to the Study IP variants for the respective study arm they are randomized into.
