Evaluation of Heated Tobacco Devices and Stick Flavors for Smoking Reduction and Abstinence Among Adult Cigarette Smokers Aged 21 to 65

What this Trial Is About

Researchers are evaluating the effect of providing access to two types of heated tobacco products HTP on smoking reduction and abstinence among healthy adult smokers aged 21 to 65 years in the United States. This multi-site, open-label study aims to assess how using HTP devices with different flavored stick variants influences smokers ability to stop or reduce combustible cigarette use over a 3-month period. The primary goal is to measure the rate of complete cigarette abstinence in the final seven days of the study. Participants are randomly assigned to one of two study groups one using a one-piece HTP device and the other using a two-piece HTP device. Each device group includes access to four stick variantstwo menthol and two tobacco flavorsunder the brand name virto. The study includes a 90-day actual use period where participants try all four stick variants during a 1-week product trial and then continue use as they choose. The interventions are designed to explore the impact of these devices and flavors on cigarette smoking habits. Throughout the study, participants complete questionnaires via a smartphone app and undergo assessments related to cigarette use and product preferences. Researchers track cigarette reduction, switching to HTP use, time to abstinence, and adverse events over the 3-month period. The primary outcome is self-reported abstinence from combustible cigarettes in the last 7 days of the study. Secondary measures include reduction in cigarette use by at least 50%, complete switching to HTP, and safety monitoring. The total study duration spans up to 3 months with ongoing data collection and follow-up.

A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers