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

NCT07598136 | Not Yet Recruiting

• 1 other identifier: PHI262612
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 7

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

Keywords

Tobacco Harm Reduction; Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

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

  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.

  13 Weeks

Secondary Outcomes (7)

• Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3.

  13 weeks

• Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).

  13 weeks

• Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)

  13 weeks

• Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3.

  13 weeks

• Time to first 7-day abstinence by Study Arm and preferred flavor group

  13 weeks

Study Arms (3)

Tobacco and two flavors of non-tobacco/non-menthol/mint

ACTIVE COMPARATOR

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

Other: P2613422; Other: P2615522; Other: P2615122

Tobacco, Mint, and Menthol Flavor

ACTIVE COMPARATOR

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

Other: P2613422; Other: P2611222; Other: P2615422

Tobacco Flavor

ACTIVE COMPARATOR

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

Other: P2613422

Interventions

P2613422 OTHER

Tobacco Flavor

Tobacco Flavor; Tobacco and two flavors of non-tobacco/non-menthol/mint; Tobacco, Mint, and Menthol Flavor

P2611222 OTHER

Menthol Flavor

Tobacco, Mint, and Menthol Flavor

P2615522 OTHER

Non-tobacco, Non-menthol/Mint Flavor

Tobacco and two flavors of non-tobacco/non-menthol/mint

P2615122 OTHER

Non-tobacco, Non-menthol/Mint Flavor

Tobacco and two flavors of non-tobacco/non-menthol/mint

P2615422 OTHER

Mint Flavor

Tobacco, Mint, and Menthol Flavor

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (7)

Sago Orlando

Maitland, Florida, 32751, United States

Location

Sago Atlanta

Atlanta, Georgia, 30328, United States

Location

Sago St. Louis

St Louis, Missouri, 63131, United States

Location

L&E Raleigh

Raleigh, North Carolina, 27612, United States

Location

Sago Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

Sago Dallas

Dallas, Texas, 75254, United States

Location

Sago Houston

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Melissa Tapia, Ph.D.

  RAIS Company

  STUDY DIRECTOR

Central Study Contacts

Montgomery E. Hedgecock

CONTACT

336-741-3761; montgomery_hedgecock@rjrt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 20, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): January 21, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)