NCT07710820 A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers
| NCT ID | NCT07710820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RAI Services Company |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,060 participants |
| Start Date | 2026-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,060 participants in total. It began in 2026-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07710820 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07710820 currently recruiting?
Yes, NCT07710820 is actively recruiting participants. Contact the research team at smithe13@rjrt.com for enrollment information.
Where is the NCT07710820 trial being conducted?
This trial is being conducted at Brandon, United States, Coral Springs, United States, Aurora, United States, Gurnee, United States and 5 additional locations.
Who is sponsoring the NCT07710820 clinical trial?
NCT07710820 is sponsored by RAI Services Company. The trial plans to enroll 1,060 participants.