A Multi-Site Two-Arm Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Combustible Cigarette Smokers
RAI Services Company
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.
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
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
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, wi…