Recruiting

E-Cigarette

Sponsor:

RAI Services Company

Code:

NCT07879638

Conditions

Smoking

Tobacco

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

FT25614

FT25615

FT25616

Study Details

Brief summary:

This is a multi-site, open-label, single arm study to evaluate the rate of smoking abstinence by the end of the study with healthy adult consumers of cigarettes when provided with an e-cigarette over a 13 week study period.

Conditions

Smoking

Tobacco

Study ID

NCT07879638

Start date

Sep 30, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

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 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.

Study Design

Enrollment

480 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Self Selection Arm

Participants in the study are allowed to self-select from the following three IP flavor options.

Interventions

FT25614

Tobacco SKU #1

FT25615

Tobacco SKU #2

FT25616

Tobacco SKU #3

Primary outcome measure

  • Impact of varying levels of access to tobacco flavor options [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Montgomery Hedgecock

336-741-3761montgomery_hedgecock@rjrt.com

Locations

Sago Atlanta

Recruiting

Atlanta, Georgia, United States, 30328

Sago Chicago

Recruiting

Chicago, Illinois, United States, 60611

Sago New Jersey

Recruiting

Iselin, New Jersey, United States, 08830

Sago Dallas

Recruiting

Dallas, Texas, United States, 75254

More Information

Sponsor

RAI Services Company

Last update posted

Oct 19, 2026

Last verified

Aug, 2026

Keywords

  • Tobacco Harm Reduction
  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by RAI Services Company on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.