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Clinical Trials in the USA / NCT07598136
Recruiting Not applicable

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

NCT07598136 · tracked via the Priya Life Science USA tracker
Sponsor
RAI Services Company
Phase
Not applicable
Started
2026-05-14
Last updated
2026-06-03

Condition(s) studied

SmokingTobacco

Investigational drug(s) / intervention(s)

P2613422P2611222P2615522P2615122P2615422

P2613422: Tobacco Flavor

P2611222: Menthol Flavor

P2615522: Non-tobacco, Non-menthol/Mint Flavor

P2615122: Non-tobacco, Non-menthol/Mint Flavor

P2615422: Mint Flavor

Study summary

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Eligibility

Sex
ALL
Min age
21 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Sago Orlando Maitland Florida Recruiting
Sago Atlanta Atlanta Georgia Recruiting
Sago St. Louis St Louis Missouri Recruiting
L&E Raleigh Raleigh North Carolina Recruiting
Sago Philadelphia Philadelphia Pennsylvania Recruiting
Sago Dallas Dallas Texas Recruiting
Sago Houston Houston Texas Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07598136 on ClinicalTrials.gov ↗ ← All trials in the USA