A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers

Part of paid clinical trials in Brandon, Florida.

Sponsor
RAI Services Company
Study ID
NCT07710820
Status
Recruiting
Apply to this trial

Conditions

  • Smoking
  • Tobacco

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 31237616 — OTHER
    Tobacco Flavor #1
  • 31237617 — OTHER
    Tobacco Flavor #2
  • 31237571 — OTHER
    Menthol #1
  • 31237581 — OTHER
    Menthol #2

Study Details

The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). The primary study objective is to evaluate the impact of access to HTP Device 1 or HTP Device 2 and a single stick variant on the rate of final 7-day abstinence from smoking cigarettes among U.S. adult smokers at the end of a 3-month study period.

Key Dates

First listed
Jul 17, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,060 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: HTP Device 1
    HTP Device (One Piece) with two menthol and two tobacco stick variants
  • Active Comparator: HTP Device 2
    HTP Device (Two Piece) with two menthol and two tobacco stick variants

Primary Outcome Measure

Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm. [ Time Frame: 7 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Opinions BrandonBrandonFlorida33511-
Opinions Coral SpringsCoral SpringsFlorida33071-
Opinions ChicagoAuroraIllinois60504-
Opinions ChicagoGurneeIllinois60031-
Opinions Las VegasLas VegasNevada89107-
Opinions Las VegasLas VegasNevada89119-
Opinions Fort WorthFort WorthTexas76132-
Opinions HoustonHoustonTexas77070-
Opinions DallasHurstTexas76053-

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