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Study on ENDS Flavor Availability and Smoking Abstinence

This study is looking at how different flavors in electronic nicotine delivery systems (ENDS) affect whether people who smoke combustible cigarettes can quit. Researchers will provide you with an ENDS device and different flavored e-liquids, such as Tobacco Flavor, Menthol Flavor, Mint Flavor, or Non-tobacco/Non-menthol/Non-mint Flavor. The main goal is to see if you can stop smoking combustible cigarettes for the last 7 days of the 13-week study period. You may be able to join if you are between 21 and 65 years old, generally healthy, and able to read English. The current status of this study is unclear, so it's not known if they are actively recruiting.

Study design
This is a multi-site, open-label, randomized controlled trial planning to enroll 1280 participants.
What's involved
You will attend mandatory site visits on Days 0, 30, 60, and 90, with optional visits on Days 7, 14, and 21 in the first month. The study period lasts 13 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your abstinence from smoking will be measured at the end of the 13-week 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.

NCT07598136

A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers

Recruiting
NAAges 21–65Interventional
RAI Services Company
~1,280 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:P2613422P2611222P2615522P2615122P2615422

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
Measured over 13 Weeks

Conditions

Smoking
Tobacco

Explore related trials

Smoking

Where it's being run

7 sites across 6 states
Texas2
Florida1
Georgia1
Missouri1
North Carolina1
Pennsylvania1

Study leadership

  • Melissa Tapia, Ph.D. · STUDY_DIRECTOR · RAIS Company

Who to contact

Montgomery E. Hedgecock
[email protected]
336-741-3761
Email the study team

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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.

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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.
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

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.

What this trial measures

  • Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period13 Weeks

    The estimate of the risk ratio for self-reporting past 7-day abstinence from CC smoking during the final 7 days of the 13-week study period in (i) Study Arm 1 (tobacco and two NTNM flavors) versus Study Arm 3 (tobacco flavor only); and (ii) Study Arm 2 (tobacco, menthol, and mint flavors) versus Study Arm 3.