Recruiting

HTP Device 1 & HTP Device 2

Sponsor:

RAI Services Company

Code:

NCT07710820

Conditions

Smoking

Tobacco

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

31237616

31237617

31237571

31237581

Study Details

Brief summary:

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.

Conditions

Smoking

Tobacco

Study ID

NCT07710820

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 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, verified with government-issued identification.
  • All female (assigned at birth) 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
  • Currently smoke at least five combustible cigarettes on smoking days in the past 30 days.
  • Smoke combustible cigarettes on 15 or more of the past 30 days.
  • Smoked at least 100 factory-made filtered menthol and/or non-menthol combustible cigarettes in their lifetime prior to the Site Enrollment Visit.
  • Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit.
  • Own 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.
  • Must try all four stick variants during the 1-week product trial period.
  • Must indicate a neutral/positive intention to use at least one stick variant following the product trial period.

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.
  • Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
  • Participants who have used electronic nicotine delivery system (ENDS), nicotine pouches, HTP or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, other combustible tobacco/nicotine 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.
  • Employee of a company that manufactures tobacco or HTPs.
  • Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or HTPs.
  • Have taken part in a tobacco/nicotine research study in the past 30 days.

Study Design

Enrollment

1060 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

31237616

Tobacco Flavor #1

31237617

Tobacco Flavor #2

31237571

Menthol #1

31237581

Menthol #2

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 and Locations

Central contacts

Emily Smith

336-741-2396smithe13@rjrt.com

Locations

Opinions Brandon

Recruiting

Brandon, Florida, United States, 33511

Opinions Coral Springs

Recruiting

Coral Springs, Florida, United States, 33071

Opinions Chicago

Recruiting

Aurora, Illinois, United States, 60504

Opinions Chicago

Recruiting

Gurnee, Illinois, United States, 60031

Opinions Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89107

Opinions Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89119

Opinions Fort Worth

Recruiting

Fort Worth, Texas, United States, 76132

Opinions Houston

Recruiting

Houston, Texas, United States, 77070

Opinions Dallas

Recruiting

Hurst, Texas, United States, 76053

More Information

Sponsor

RAI Services Company

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RAI Services Company on 2026-07-17.