Recruiting

Evaluation of Heated Tobacco Product's Impact on Cigarette Reduction in Adult Smokers

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Study Aim

This study aims to evaluate the impact of a heated tobacco product on reducing cigarette consumption in adult smokers, specifically focusing on the number and proportion of participants who report complete cigarette abstinence in the final 7 days of a 3-month study period.

What is being tested

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Who is being recruted

Behavior+1

+ Tobacco Smoking

+ Smoking

From 21 to 65 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2026
See protocol details

Summary

Principal SponsorRAI Services Company
Study ContactEmily Smith
Last updated: July 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

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).

NCT07710820
Principal SponsorRAI Services Company
Study ContactEmily Smith
Last updated: July 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1060 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorTobacco SmokingSmokingTobacco Use

Criteria

11 inclusion criteria required to participate
Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit
Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent, verified with government-issued identification
Smoke combustible cigarettes on 15 or more of the past 30 days
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
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11 exclusion criteria prevent from participating
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
Female participants who self-report not using adequate methods to prevent pregnancy
Persons with pacemakers or other embedded electronic medical devices fitted
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Recruiting

Opinions Brandon

Brandon, United StatesOpen Opinions Brandon in Google Maps
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Opinions Coral Springs

Coral Springs, United States
Recruiting

Opinions Chicago

Aurora, United States
Recruiting

Opinions Chicago

Gurnee, United States
Recruiting
9 Study Centers