What is this study trying to find out about smoking?

This study is evaluating how access to two types of heated tobacco products affects smoking reduction and abstinence among adult smokers. It aims to understand whether using these devices with various flavored sticks helps smokers reduce or stop cigarette use over three months. The sponsor of this research is RAI Services Company.

Who may be eligible for this smoking clinical trial?

Adults aged 21 to 65 who smoke at least five cigarettes on smoking days and have smoked 100 or more factory-made cigarettes in their lifetime may be eligible. Participants must own a smartphone and agree to try all study products. Please review eligibility criteria for more details.

Is there any cost to participate in this smoking clinical trial?

Study-related care, including the study devices, flavored sticks, and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 21Years - 65Years

All Genders

Healthy Volunteers

ID07710820

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

Led by RAI Services Company · Updated on 2026-07-17

1060

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Able to read, understand, and sign informed consent and complete questionnaires in English
Generally healthy adults aged 21 to 65 years
Female participants assigned at birth agree to a negative pregnancy test and confirm not pregnant or intending pregnancy
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
Have smoked at least 100 factory-made filtered menthol or non-menthol cigarettes in lifetime
Indicate neutral or positive intention to use at least one stick variant at enrollment
Own a smartphone with internet access to download study app and receive notifications
Agree to participate and follow study requirements
Must try all four stick variants during the 1-week product trial
Must indicate neutral or positive intention to use at least one stick variant after the product trial

You will not qualify if you...

Female participants who are pregnant, breastfeeding, or planning pregnancy within 6 months
Male participants unwilling to use contraception or refrain from sperm donation unless vasectomized or abstinent
Female participants not using adequate pregnancy prevention
Persons with pacemakers or other implanted electronic medical devices
Participants with unstable heart conditions, severe hypertension, or diabetes
Individuals reporting poor or unknown general physical or mental health
Participants who used electronic nicotine delivery systems, nicotine pouches, heated tobacco products, smokeless tobacco, other combustible tobacco, or oral nicotine products on 5 or more days in past 30 days
Participants who used nicotine replacement therapy or smoking cessation drugs in past 30 days
Employees of companies manufacturing tobacco or heated tobacco products
Persons involved in litigation with tobacco or heated tobacco manufacturers
Participation in tobacco/nicotine research study in past 30 days

Research Team

Emily Smith

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