Recruiting

ENDS

Sponsor:

RAI Services Company

Code:

NCT07598136

Conditions

Smoking

Tobacco

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

P2613422

P2611222

P2615522

P2615122

P2615422

Study Details

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.

Conditions

Smoking

Tobacco

Study ID

NCT07598136

Start date

May 14, 2026

Status verified date

Jun, 2026

Completion date

Jan 21, 2027

Anticipated

Primary completion date

Dec 17, 2026

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 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.

Study Design

Enrollment

1280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Tobacco and two flavors of non-tobacco/non-menthol/mint

Participants can choose between tobacco and two non-tobacco/non-menthol/mint flavor variants at one nicotine level (5%).

active comparator: Tobacco, Mint, and Menthol Flavor

Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%).

active comparator: Tobacco Flavor

Participants can use a tobacco flavor variant at one nicotine level (5%).

Interventions

P2613422

Tobacco Flavor

P2611222

Menthol Flavor

P2615522

Non-tobacco, Non-menthol/Mint Flavor

P2615122

Non-tobacco, Non-menthol/Mint Flavor

P2615422

Mint Flavor

Primary outcome measure

  • Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period [ Time Frame: 13 Weeks ]

Central Contacts and Locations

Central contacts

Montgomery E. Hedgecock

336-741-3761montgomery_hedgecock@rjrt.com

Locations

Sago Orlando

Recruiting

Maitland, Florida, United States, 32751

Sago Atlanta

Recruiting

Atlanta, Georgia, United States, 30328

Sago St. Louis

Recruiting

St Louis, Missouri, United States, 63131

L&E Raleigh

Recruiting

Raleigh, North Carolina, United States, 27612

Sago Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Sago Dallas

Recruiting

Dallas, Texas, United States, 75254

Sago Houston

Recruiting

Houston, Texas, United States, 77027

More Information

Sponsor

RAI Services Company

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RAI Services Company on 2026-06-03.