Heated tobacco devices tested as a tool to help smokers kick the habit

NCT ID NCT07710820

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether giving adult smokers access to a heated tobacco product (HTP) helps them stop smoking cigarettes. About 1,060 healthy smokers aged 21–65 will use either HTP Device 1 or Device 2 with different stick flavors (tobacco or menthol) for 3 months. The main goal is to see how many people completely stop smoking cigarettes during the final week of the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
heated tobacco product (HTP) with tobacco or menthol sticks
What this could lead to
If successful, this could offer a less harmful alternative for smokers who struggle to quit, potentially reducing smoking-related diseases.
What could go wrong
This is a short-term study (3 months) with no blinding, so results may not reflect long-term quitting or real-world use. Heated tobacco still contains nicotine and is not risk-free.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,060 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Tobacco Smoking Tobacco Use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Opinions Brandon

    RECRUITING

    Brandon, Florida, 33511, United States

  • Opinions Chicago

    RECRUITING

    Aurora, Illinois, 60504, United States

  • Opinions Chicago

    RECRUITING

    Gurnee, Illinois, 60031, United States

  • Opinions Coral Springs

    RECRUITING

    Coral Springs, Florida, 33071, United States

  • Opinions Dallas

    RECRUITING

    Hurst, Texas, 76053, United States

  • Opinions Fort Worth

    RECRUITING

    Fort Worth, Texas, 76132, United States

  • Opinions Houston

    RECRUITING

    Houston, Texas, 77070, United States

  • Opinions Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89107, United States

  • Opinions Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89119, United States

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