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

NCT07710820 | Recruiting

• 1 other identifier: PHI252504
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 9

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

Keywords

Tobacco Harm Reduction; Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (5)

• The number and proportion of participants who completely switch from combustible cigarette smoking to HTP device 1 or HTP device 2 during the entire final 7 days of the 3 month study period in each study arm and by stick variant within the study arm.

  7 days

• The number and proportion of participants who reduce their combustible cigarettes by more than or equal to 50% within their average weekly cigarettes per day from baseline to final 7 days of the study period in each study arm and by stick variant.

  3 months

• The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm

  3 months

• The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm

  3 months

• The number and type of adverse experiences/events in relation to use of the Study IP in each study arm and by stick variant within each study arm

  3 months

Study Arms (2)

HTP Device 1

ACTIVE COMPARATOR

HTP Device (One Piece) with two menthol and two tobacco stick variants

Other: 31237616; Other: 31237617; Other: 31237571; Other: 31237581

HTP Device 2

ACTIVE COMPARATOR

HTP Device (Two Piece) with two menthol and two tobacco stick variants

Other: 31237616; Other: 31237617; Other: 31237571; Other: 31237581

Interventions

31237616 OTHER

Tobacco Flavor #1

HTP Device 1; HTP Device 2

31237617 OTHER

Tobacco Flavor #2

HTP Device 1; HTP Device 2

31237571 OTHER

Menthol #1

HTP Device 1; HTP Device 2

31237581 OTHER

Menthol #2

HTP Device 1; HTP Device 2

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, 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.

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 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.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (9)

Opinions Brandon

Brandon, Florida, 33511, United States

RECRUITING

Opinions Coral Springs

Coral Springs, Florida, 33071, United States

RECRUITING

Opinions Chicago

Aurora, Illinois, 60504, United States

RECRUITING

Opinions Chicago

Gurnee, Illinois, 60031, United States

RECRUITING

Opinions Las Vegas

Las Vegas, Nevada, 89107, United States

RECRUITING

Opinions Las Vegas

Las Vegas, Nevada, 89119, United States

RECRUITING

Opinions Fort Worth

Fort Worth, Texas, 76132, United States

RECRUITING

Opinions Houston

Houston, Texas, 77070, United States

RECRUITING

Opinions Dallas

Hurst, Texas, 76053, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Emily Smith

CONTACT

336-741-2396; smithe13@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: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)