A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Smoking Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Montgomery E. Hedgecock
- Telefonszám: 336-741-3761
- E-mail: montgomery_hedgecock@rjrt.com
Tanulmányi helyek
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Florida
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Maitland, Florida, Egyesült Államok, 32751
- Toborzás
- Sago Orlando
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30328
- Toborzás
- Sago Atlanta
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Missouri
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St Louis, Missouri, Egyesült Államok, 63131
- Toborzás
- Sago St. Louis
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North Carolina
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Raleigh, North Carolina, Egyesült Államok, 27612
- Toborzás
- L&E Raleigh
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Pennsylvania
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Philadelphia, Pennsylvania, Egyesült Államok, 19103
- Toborzás
- Sago Philadelphia
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Texas
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Dallas, Texas, Egyesült Államok, 75254
- Toborzás
- Sago Dallas
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Houston, Texas, Egyesült Államok, 77027
- Toborzás
- Sago Houston
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
- All female (assigned at birth) and those who identify as "intersex" or "unknown 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.
- Currently smoke at least 5 CC on smoking days in the past 30 days.
- Smoke CC on 15 or more of the past 30 days.
- Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
- Indicate a willingness to use ENDS.
- Own and regularly use 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.
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 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.
- Persons who self-report they are allergic/sensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.
- Participants who self-report poor physical or mental health.
- Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible 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.
- Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
- Employee of a company that manufactures tobacco or ENDS products.
- Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
- Have taken part in a tobacco/nicotine research study in the past 30 days.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: Dohány íz
A résztvevők egy nikotinszinten (5%) használhatnak dohány ízesítést.
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Tobacco Flavor
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Aktív összehasonlító: Tobacco and two flavors of non-tobacco/non-menthol/mint
Participants can choose between tobacco and two non-tobacco/non-menthol/mint flavor variants at one nicotine level (5%).
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Tobacco Flavor
Non-tobacco, Non-menthol/Mint Flavor
Non-tobacco, Non-menthol/Mint Flavor
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Aktív összehasonlító: Tobacco, Mint, and Menthol Flavor
Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%).
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Tobacco Flavor
Menthol Flavor
Mint Flavor
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
Időkeret: 13 Weeks
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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.
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13 Weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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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.
Időkeret: 13 weeks
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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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13 weeks
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Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).
Időkeret: 13 weeks
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13 weeks
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Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)
Időkeret: 13 weeks
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"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
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13 weeks
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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.
Időkeret: 13 weeks
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13 weeks
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Time to first 7-day abstinence by Study Arm and preferred flavor group
Időkeret: 13 weeks
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13 weeks
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Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group.
Időkeret: 13 weeks
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13 weeks
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Safety profile of the study IP
Időkeret: 13 weeks
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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.
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13 weeks
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi igazgató: Melissa Tapia, Ph.D., RAIS Company
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PHI262612
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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