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The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) over a 13-week study period.
Potential participants will be recruited and enrolled at multiple sites across the U.S. They will complete a pre-screening questionnaire to assess their study eligibility approximately 60 days prior to enrollment. Participants who meet pre-screening criteria will provide an informed consent to attend a screening and enrollment visit (SEV), which is a mandatory site visit (MSV) during which participants will be screened, and eligible participants will be randomized to one of the three study arms.
Participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their Study Arm.
All participants will attend MSV on Days 0, 30, 60, and 90 with the option of changing to a different flavor among the available flavors based upon their assigned Study Arm, if applicable. In the first 4-weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits (OSV) on Days 7, 14, and 21, with the option of changing flavors to a different flavor among the available flavors in their assigned Study Arm. During the 13-week study period, participants will be free to use the ENDS and any other tobacco or nicotine products as desired. The ENDS Version 2 Power Unit technology will measure their puffing topography during use (puff duration and inter-puff interval). Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on their own smart phones. Surveys will collect data on the number of CC smoked the previous day, current flavor use, product liking, number of cigarette quit attempts, and any other tobacco or nicotine products used, intent to substitute their UB CC for the Study IP and social/environmental factors influencing switching intent. At the conclusion of the study period, all participants will return to the sites for a close out period and will be discharged from the study. Safety and adverse events/experiences (AEs) will be monitored throughout the study via a safety Hotline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco and two flavors of non-tobacco/non-menthol/mint | Active Comparator | Participants can choose between tobacco and two non-tobacco/non-menthol/mint flavor variants at one nicotine level (5%). |
|
| Tobacco, Mint, and Menthol Flavor | Active Comparator | Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%). |
|
| Tobacco Flavor | Active Comparator | Participants can use a tobacco flavor variant at one nicotine level (5%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2613422 | Other | Tobacco Flavor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period | The estimate of the risk ratio for self-reporting past 7-day abstinence from CC smoking during the final 7 days of the 13-week study period in (i) Study Arm 1 (tobacco and two NTNM flavors) versus Study Arm 3 (tobacco flavor only); and (ii) Study Arm 2 (tobacco, menthol, and mint flavors) versus Study Arm 3. | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3. | The estimate of the proportion of participants who completely switched from CC smoking to Vuse ENDS during the entire final 7 days of the 13-week study period in Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3. Complete switching is defined as being abstinent from smoking CCs during the final 7-days of the study period, as well as being an adopter of Study IP (defined as ≥ 4 days of Study IP use [verified by puff topography data] for each week during the final two weeks of the study period). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Montgomery E. Hedgecock | Contact | 336-741-3761 | montgomery_hedgecock@rjrt.com |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Tapia, Ph.D. | RAIS Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sago Orlando | Recruiting | Maitland | Florida | 32751 | United States | |
| Sago Atlanta |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| P2611222 | Other | Menthol Flavor |
|
| P2615522 | Other | Non-tobacco, Non-menthol/Mint Flavor |
|
| P2615122 | Other | Non-tobacco, Non-menthol/Mint Flavor |
|
| P2615422 | Other | Mint Flavor |
|
| 13 weeks |
| Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2). | 13 weeks |
| Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2) | "Preferred Flavor" to be defined in the statistical analysis plan (SAP), and each participant's preferred flavor will be used to assign them to their "preferred flavor group", which will be incorporated in subsequent analyses | 13 weeks |
| Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3. | 13 weeks |
| Time to first 7-day abstinence by Study Arm and preferred flavor group | 13 weeks |
| Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group. | 13 weeks |
| Safety profile of the study IP | An additional endpoint of critical importance is AEs per participant, which will be described in the tables, figures, and listings (TFLs) in addition to the final study report. No inferential testing is planned for AEs. | 13 weeks |
| Recruiting |
| Atlanta |
| Georgia |
| 30328 |
| United States |
| Sago St. Louis | Recruiting | St Louis | Missouri | 63131 | United States |
| L&E Raleigh | Recruiting | Raleigh | North Carolina | 27612 | United States |
| Sago Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19103 | United States |
| Sago Dallas | Recruiting | Dallas | Texas | 75254 | United States |
| Sago Houston | Recruiting | Houston | Texas | 77027 | United States |