The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). The primary study objective is to evaluate the impact of access to HTP Device 1 or HTP Device 2 and a single stick variant on the rate of final 7-day abstinence from smoking cigarettes among U.S. adult smokers at the end of a 3-month study period.
This will be a multi-site, open-label, two-arm study to evaluate the rate of end of study complete combustible cigarette (CC) reduction in healthy adult consumers of CC when given access to a heated tobacco product (HTP) device (glo or glo plus), with one of four variants of HTP consumables (also known as "sticks" or "stick variants", under the brand name "virto") over a 3-month (90-day) actual use period (AUP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,060
Tobacco Flavor #1
Tobacco Flavor #2
Menthol #1
Menthol #2
Opinions Brandon
Brandon, Florida, United States
RECRUITINGOpinions Coral Springs
Coral Springs, Florida, United States
RECRUITINGOpinions Chicago
Aurora, Illinois, United States
RECRUITINGOpinions Chicago
Gurnee, Illinois, United States
RECRUITINGOpinions Las Vegas
Las Vegas, Nevada, United States
RECRUITINGOpinions Las Vegas
Las Vegas, Nevada, United States
RECRUITINGOpinions Fort Worth
Fort Worth, Texas, United States
RECRUITINGOpinions Houston
Houston, Texas, United States
RECRUITINGOpinions Dallas
Hurst, Texas, United States
RECRUITINGNumber and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm.
Time frame: 7 days
The number and proportion of participants who completely switch from combustible cigarette smoking to HTP device 1 or HTP device 2 during the entire final 7 days of the 3 month study period in each study arm and by stick variant within the study arm.
Time frame: 7 days
The number and proportion of participants who reduce their combustible cigarettes by more than or equal to 50% within their average weekly cigarettes per day from baseline to final 7 days of the study period in each study arm and by stick variant.
Time frame: 3 months
The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm
Time frame: 3 months
The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm
Time frame: 3 months
The number and type of adverse experiences/events in relation to use of the Study IP in each study arm and by stick variant within each study arm
Time frame: 3 months
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