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

Part of paid clinical trials in Maitland, Florida.

Sponsor
RAI Services Company
Study ID
NCT07598136
Status
Recruiting
Apply to this trial

Conditions

  • Smoking
  • Tobacco

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • P2613422 — OTHER
    Tobacco Flavor
  • P2611222 — OTHER
    Menthol Flavor
  • P2615522 — OTHER
    Non-tobacco, Non-menthol/Mint Flavor
  • P2615122 — OTHER
    Non-tobacco, Non-menthol/Mint Flavor
  • P2615422 — OTHER
    Mint Flavor

Study Details

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.

Key Dates

Start date
May 14, 2026
Status verified
Jun 2026
Primary completion
Dec 17, 2026
Completion
Jan 21, 2027

Study Design

Enrollment
1,280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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%).

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

Locations (7)

FacilityCityStateZIPSite coordinators
Sago OrlandoMaitlandFlorida32751-
Sago AtlantaAtlantaGeorgia30328-
Sago St. LouisSt LouisMissouri63131-
L&E RaleighRaleighNorth Carolina27612-
Sago PhiladelphiaPhiladelphiaPennsylvania19103-
Sago DallasDallasTexas75254-
Sago HoustonHoustonTexas77027-

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