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A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers

1 juni 2026 bijgewerkt door: RAI Services Company

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1280

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Florida
      • Maitland, Florida, Verenigde Staten, 32751
        • Werving
        • Sago Orlando
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30328
        • Werving
        • Sago Atlanta
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63131
        • Werving
        • Sago St. Louis
    • North Carolina
      • Raleigh, North Carolina, Verenigde Staten, 27612
        • Werving
        • L&E Raleigh
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19103
        • Werving
        • Sago Philadelphia
    • Texas
      • Dallas, Texas, Verenigde Staten, 75254
        • Werving
        • Sago Dallas
      • Houston, Texas, Verenigde Staten, 77027
        • Werving
        • Sago Houston

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Tabakssmaak
Deelnemers kunnen een tabakssmaakvariant gebruiken op één nicotinegehalte (5%).
Ander: P2613422
Tobacco Flavor
Actieve vergelijker: 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%).
Ander: P2613422
Tobacco Flavor
Ander: P2615522
Non-tobacco, Non-menthol/Mint Flavor
Ander: P2615122
Non-tobacco, Non-menthol/Mint Flavor
Actieve vergelijker: Tobacco, Mint, and Menthol Flavor
Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%).
Ander: P2613422
Tobacco Flavor
Ander: P2611222
Menthol Flavor
Ander: P2615422
Mint Flavor

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
Tijdsspanne: 13 Weeks
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 13 weeks
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).
13 weeks
Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).
Tijdsspanne: 13 weeks
13 weeks
Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)
Tijdsspanne: 13 weeks
"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.
Tijdsspanne: 13 weeks
13 weeks
Time to first 7-day abstinence by Study Arm and preferred flavor group
Tijdsspanne: 13 weeks
13 weeks
Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group.
Tijdsspanne: 13 weeks
13 weeks
Safety profile of the study IP
Tijdsspanne: 13 weeks
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

RAI Services Company

Onderzoekers

  • Studie directeur: Melissa Tapia, Ph.D., RAIS Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 mei 2026

Primaire voltooiing (Geschat)

17 december 2026

Studie voltooiing (Geschat)

21 januari 2027

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PHI262612

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Roken

Klinische onderzoeken op P2613422

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