About this trial
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.
All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
Currently smoke at least 5 CC on smoking days in the past 30 days.
Disqualifiers
Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
Female participants who self-report not using adequate methods to prevent pregnancy.
Persons with pacemakers or other embedded electronic medical devices fitted.
Trial design
Parallel
Treatments tested in this trial
P2613422
Other interventionTobacco Flavor
P2611222
Other interventionMenthol Flavor
P2615522
Other interventionNon-tobacco, Non-menthol/Mint Flavor
P2615122
Other interventionNon-tobacco, Non-menthol/Mint Flavor
P2615422
Other interventionMint Flavor
Treatment groups
Trial outcomes
Primary outcomes
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
The estimate of the risk ratio for self-reporting past 7-day abstinence from CC smoking during the final 7 days of the 13-week study period in (i) Study Arm 1 (tobacco and two NTNM flavors) versus Study Arm 3 (tobacco flavor only); and (ii) Study Arm 2 (tobacco, menthol, and mint flavors) versus Study Arm 3.
Secondary outcomes
Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3.
The estimate of the proportion of participants who completely switched from CC smoking to Vuse ENDS during the entire final 7 days of the 13-week study period in Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3. Complete switching is defined as being abstinent from smoking CCs during the final 7-days of the study period, as well as being an adopter of Study IP (defined as ≥ 4 days of Study IP use \[verified by puff topography data\] for each week during the final two weeks of the study period).
Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).
Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)
"Preferred Flavor" to be defined in the statistical analysis plan (SAP), and each participant's preferred flavor will be used to assign them to their "preferred flavor group", which will be incorporated in subsequent analyses
Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3.
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