About this trial
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.
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, verified with government-issued identification.
All female (assigned at birth) 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
Currently smoke at least five combustible cigarettes 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 time of 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
31237616
Other interventionTobacco Flavor #1
31237617
Other interventionTobacco Flavor #2
31237571
Other interventionMenthol #1
31237581
Other interventionMenthol #2
Treatment groups
Trial outcomes
Primary outcomes
Number 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.
Secondary outcomes
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.
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.
The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm
The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm
Sponsors and contacts
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