Access to multiple tobacco flavors to help adult cigarette smokers quit using e-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 is a multi-site, open-label, single-arm trial that looks at end-of-study smoking abstinence in healthy adult cigarette smokers who are provided an electronic nicotine delivery system with multiple flavor options over 13 weeks. Results will be compared to a prior randomized trial that used a single flavor. Participants will use a study app to report surveys and may receive a study-provided phone for study activities. The study is sponsored by RAI Services Company and conducted at three U.S. sites.

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 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 or be willing to use a study-provided phone for surveys and other required study activities.
* 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 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.
* 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, or other combustible products and other oral nicotine products (tablets, gums, lozenges) on 11 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

• MARS Research
  Fort Lauderdale, Florida, United States Recruiting
• Sago Atlanta
  Atlanta, Georgia, United States Recruiting
• Sago Chicago
  Chicago, Illinois, United States Recruiting
• Sago New Jersey
  Iselin, New Jersey, United States Recruiting
• Sago Dallas
  Dallas, Texas, United States Recruiting

Study contacts

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

Similar studies

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

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

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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.