NCT07598136 A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
| NCT ID | NCT07598136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RAI Services Company |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,280 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2026-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,280 participants in total. It began in 2026-05-14 with a primary completion date of 2026-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Melissa Tapia, Ph.D.
STUDY DIRECTOR
RAIS Company
Frequently Asked Questions
Who can join the NCT07598136 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07598136 currently recruiting?
Yes, NCT07598136 is actively recruiting participants. Contact the research team at montgomery_hedgecock@rjrt.com for enrollment information.
Where is the NCT07598136 trial being conducted?
This trial is being conducted at Maitland, United States, Atlanta, United States, St Louis, United States, Raleigh, United States and 3 additional locations.
Who is sponsoring the NCT07598136 clinical trial?
NCT07598136 is sponsored by RAI Services Company. The principal investigator is Melissa Tapia, Ph.D. at RAIS Company. The trial plans to enroll 1,280 participants.