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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTP Device 1 | Active Comparator | HTP Device (One Piece) with two menthol and two tobacco stick variants |
|
| HTP Device 2 | Active Comparator | HTP Device (Two Piece) with two menthol and two tobacco stick variants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 31237616 | Other | Tobacco Flavor #1 |
| |
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Smith | Contact | 336-741-2396 | smithe13@rjrt.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Opinions Brandon | Recruiting | Brandon | Florida | 33511 | United States | |
| Opinions Coral Springs |
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| 31237617 |
| Other |
Tobacco Flavor #2 |
|
| 31237571 | Other | Menthol #1 |
|
| 31237581 | Other | Menthol #2 |
|
| 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 |
| Recruiting |
| Coral Springs |
| Florida |
| 33071 |
| United States |
| Opinions Chicago | Recruiting | Aurora | Illinois | 60504 | United States |
| Opinions Chicago | Recruiting | Gurnee | Illinois | 60031 | United States |
| Opinions Las Vegas | Recruiting | Las Vegas | Nevada | 89107 | United States |
| Opinions Las Vegas | Recruiting | Las Vegas | Nevada | 89119 | United States |
| Opinions Fort Worth | Recruiting | Fort Worth | Texas | 76132 | United States |
| Opinions Houston | Recruiting | Houston | Texas | 77070 | United States |
| Opinions Dallas | Recruiting | Hurst | Texas | 76053 | United States |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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