Study of Heated Tobacco Products for Smoking Abstinence
This study is looking at whether using a heated tobacco product (HTP) can help current cigarette smokers quit. Researchers want to see if giving people access to either HTP Device 1 or HTP Device 2, along with one of four tobacco flavors (Tobacco Flavor #1, Tobacco Flavor #2, Menthol #1, or Menthol #2), helps them stop smoking regular cigarettes. The main goal is to see how many participants report not smoking any regular cigarettes during the last 7 days of the 3-month study. You can join if you are a generally healthy adult between 21 and 65 years old and currently smoke cigarettes. The current status of this study is unclear.
- Study design
- This is an open-label study, meaning you and the researchers will know which heated tobacco product you are using. It involves about 1060 participants and has two groups.
- What's involved
- You would use a heated tobacco product for a 3-month (90-day) period and complete questionnaires. The study will measure your cigarette use at the end of this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurement for the study is taken during the final 7 days of the 3-month study period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07710820
A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers
Recruiting
NAAges 21–65InterventionalRAI Services Company
~1,060 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:31237616312376173123757131237581
At a glance
Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm.
Measured over 7 days
Conditions
Where it's being run
9 sites across 4 statesTexas3
Florida2
Illinois2
Nevada2
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm.7 days