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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Tobacco
• Intervention / Treatment: Other: 31237616; Other: 31237617; Other: 31237571; Other: 31237581

Detailed Description

This will be a multi-site, open-label, two-arm study to evaluate the rate of end of study complete combustible cigarette (CC) reduction in healthy adult consumers of CC when given access to a heated tobacco product (HTP) device (glo or glo plus), with one of four variants of HTP consumables (also known as "sticks" or "stick variants", under the brand name "virto") over a 3-month (90-day) actual use period (AUP).

• Study Type: Interventional
• Enrollment (Estimated): 1060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Smith; Phone Number: 336-741-2396; Email: smithe13@rjrt.com

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Opinions Brandon
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Opinions Coral Springs
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Recruiting
      • Opinions Chicago
    • Gurnee, Illinois, United States, 60031
      • Recruiting
      • Opinions Chicago
  • Nevada
    • Las Vegas, Nevada, United States, 89107
      • Recruiting
      • Opinions Las Vegas
    • Las Vegas, Nevada, United States, 89119
      • Recruiting
      • Opinions Las Vegas
  • Texas
    • Fort Worth, Texas, United States, 76132
      • Recruiting
      • Opinions Fort Worth
    • Houston, Texas, United States, 77070
      • Recruiting
      • Opinions Houston
    • Hurst, Texas, United States, 76053
      • Recruiting
      • Opinions Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HTP Device 1; HTP Device (One Piece) with two menthol and two tobacco stick variants	Other: 31237616; Tobacco Flavor #1; Other: 31237617; Tobacco Flavor #2; Other: 31237571; Menthol #1; Other: 31237581; Menthol #2
Active Comparator: HTP Device 2; HTP Device (Two Piece) with two menthol and two tobacco stick variants	Other: 31237616; Tobacco Flavor #1; Other: 31237617; Tobacco Flavor #2; Other: 31237571; Menthol #1; Other: 31237581; Menthol #2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: RAI Services Company

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Smoking; Tobacco Use; Tobacco Smoking; Tobacco Harm Reduction
• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Use; Tobacco Smoking
• Other Study ID Numbers: PHI252504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No