Summary
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.
Detailed Description
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).
Eligibility Criteria
Age Range: 21 years to 65 years
Inclusion Criteria:
* 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.
* Smoke combustible cigarettes on 15 or more of the past 30 days.
* Smoked at least 100 factory-made filtered menthol and/or non-menthol combustible cigarettes in their lifetime prior to the Site Enrollment Visit.
* Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit.
* Own a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.
* Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.
* Must try all four stick variants during the 1-week product trial period.
* Must indicate a neutral/positive intention to use at least one stick variant following the product trial period.
Exclusion Criteria:
* 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.
* Participants who self-report having an unstable heart condition, severe hypertension, or diabetes.
* Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
* Participants who have used electronic nicotine delivery system (ENDS), nicotine pouches, HTP or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, other combustible tobacco/nicotine products, and other oral nicotine products (tablets, gums, and lozenges) on 5 or more days in the past 30 days.
* Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
* Employee of a company that manufactures tobacco or HTPs.
* Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or HTPs.
* Have taken part in a tobacco/nicotine research study in the past 30 days.