How flavors of ENDS might help adults quit smoking their usual cigarettes

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 multi-site, open-label study randomizes healthy adult smokers to one of three arms that vary ENDS flavor access while using a powered ENDS device for 13 weeks. Participants begin with a trial period to sample flavors, then have regular visits over 90 days to monitor choices and abstinence from their usual cigarettes. The primary outcome is end-of-study abstinence from smoking combustible cigarettes, with flavor options including tobacco, menthol, mint, and non-tobacco flavors. The study uses self-reported data and on-site visits to track adherence and safety, while allowing continued use of other tobacco or nicotine products as advised. Eligible participants are adults 21–65 who smoke regularly and are willing to use ENDS and a study smartphone app.

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.
* All female (assigned at birth) and those who identify as "intersex" or "unknown 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.
* Currently smoke at least 5 CC on smoking days in the past 30 days.
* Smoke CC on 15 or more of the past 30 days.
* Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
* Indicate a willingness to use ENDS.
* Own and regularly use 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.

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 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.
* Persons who self-report they are allergic/sensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.
* Participants who self-report poor physical or mental health.
* Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible 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.
* Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
* Employee of a company that manufactures tobacco or ENDS products.
* Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
* Have taken part in a tobacco/nicotine research study in the past 30 days.

Where it's running

• Sago Orlando
  Maitland, Florida, United States Recruiting
• Sago Atlanta
  Atlanta, Georgia, United States Recruiting
• Sago St. Louis
  St Louis, Missouri, United States Recruiting
• L&E Raleigh
  Raleigh, North Carolina, United States Recruiting
• Sago Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Sago Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Montgomery E. Hedgecock
• Email: montgomery_hedgecock@rjrt.com
• Phone: 336-741-3761

Similar studies

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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.