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Clinical Trials in the USA / NCT07710820
Recruiting Not applicable

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

NCT07710820 · tracked via the Priya Life Science USA tracker
Sponsor
RAI Services Company
Phase
Not applicable
Started
2026-07
Last updated
2026-07-17

Condition(s) studied

SmokingTobacco

Investigational drug(s) / intervention(s)

31237616312376173123757131237581

31237616: Tobacco Flavor #1

31237617: Tobacco Flavor #2

31237571: Menthol #1

31237581: Menthol #2

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Opinions Brandon Brandon Florida Recruiting
Opinions Coral Springs Coral Springs Florida Recruiting
Opinions Chicago Aurora Illinois Recruiting
Opinions Chicago Gurnee Illinois Recruiting
Opinions Las Vegas Las Vegas Nevada Recruiting
Opinions Las Vegas Las Vegas Nevada Recruiting
Opinions Fort Worth Fort Worth Texas Recruiting
Opinions Houston Houston Texas Recruiting
Opinions Dallas Hurst Texas Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07710820 on ClinicalTrials.gov ↗ ← All trials in the USA