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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Montgomery E. Hedgecock
- Telefonnummer: 336-741-3761
- E-post: montgomery_hedgecock@rjrt.com
Studieorter
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Florida
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Maitland, Florida, Förenta staterna, 32751
- Rekrytering
- Sago Orlando
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Georgia
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Atlanta, Georgia, Förenta staterna, 30328
- Rekrytering
- Sago Atlanta
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Missouri
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St Louis, Missouri, Förenta staterna, 63131
- Rekrytering
- Sago St. Louis
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27612
- Rekrytering
- L&E Raleigh
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19103
- Rekrytering
- Sago Philadelphia
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Texas
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Dallas, Texas, Förenta staterna, 75254
- Rekrytering
- Sago Dallas
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Houston, Texas, Förenta staterna, 77027
- Rekrytering
- Sago Houston
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Tobaksmak
Deltagarna kan använda en tobaksmakvariant på en nikotinnivå (5%).
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Tobacco Flavor
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Aktiv komparator: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
Tidsram: 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.
|
13 Weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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.
Tidsram: 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).
Tidsram: 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)
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 13 weeks
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13 weeks
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Safety profile of the study IP
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Melissa Tapia, Ph.D., RAIS Company
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PHI262612
Plan för individuella deltagardata (IPD)
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