Heated tobacco access and cigarette quitting among adult smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-site, open-label study comparing two heated tobacco devices with different consumable variants to see if access leads to complete abstinence from combustible cigarettes after 90 days. Eligible adults who smoke daily and meet certain criteria will use a heated tobacco product for the study duration. Participants will complete questionnaires and be monitored at research sites in Florida and Illinois. The study aims to measure the rate of end-of-study 7-day cigarette abstinence as the primary outcome.

Why it matters

Who can join: the full rules

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.

Where it's running

• Opinions Brandon
  Brandon, Florida, United States Recruiting
• Opinions Coral Springs
  Coral Springs, Florida, United States Recruiting
• Opinions Chicago
  Aurora, Illinois, United States Recruiting
• Opinions Chicago
  Gurnee, Illinois, United States Recruiting
• Opinions Las Vegas
  Las Vegas, Nevada, United States Recruiting
• Opinions Las Vegas
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Study coordinator: Emily Smith
• Email: smithe13@rjrt.com
• Phone: 336-741-2396

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Salivary IL-8 and Serum IL-6 as Biomarkers to Distinguish Oral Premalignant Disorders in Smokers and Never-Smokers

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• Abuse liability and use patterns of IQOS heated tobacco among adult smokers

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• Communal coping in couples where both partners smoke during a quit attempt

  This project tests whether couples who tackle quitting as a team (communal coping) fare better when one partner in a smoking couple tries to quit.

  Recruiting University of Colorado, Denver · Denver, Colorado · NCT07553962

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.