A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers
13 juli 2026 uppdaterad av: RAI Services Company
A Multi-Site Two-Arm Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Combustible Cigarette Smokers
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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Beräknad)
1060
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Emily Smith
- Telefonnummer: 336-741-2396
- E-post: smithe13@rjrt.com
Studieorter
-
-
Florida
-
Brandon, Florida, Förenta staterna, 33511
- Rekrytering
- Opinions Brandon
-
Coral Springs, Florida, Förenta staterna, 33071
- Rekrytering
- Opinions Coral Springs
-
-
Illinois
-
Aurora, Illinois, Förenta staterna, 60504
- Rekrytering
- Opinions Chicago
-
Gurnee, Illinois, Förenta staterna, 60031
- Rekrytering
- Opinions Chicago
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89107
- Rekrytering
- Opinions Las Vegas
-
Las Vegas, Nevada, Förenta staterna, 89119
- Rekrytering
- Opinions Las Vegas
-
-
Texas
-
Fort Worth, Texas, Förenta staterna, 76132
- Rekrytering
- Opinions Fort Worth
-
Houston, Texas, Förenta staterna, 77070
- Rekrytering
- Opinions Houston
-
Hurst, Texas, Förenta staterna, 76053
- Rekrytering
- Opinions Dallas
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
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, verified with government-issued identification.
- All female (assigned at birth) 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
- Currently smoke at least five combustible cigarettes on smoking days in the past 30 days.
- Smoke combustible cigarettes on 15 or more of the past 30 days.
- Smoked at least 100 factory-made filtered menthol and/or non-menthol combustible cigarettes in their lifetime prior to the Site Enrollment Visit.
- Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit.
- Own 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.
- Must try all four stick variants during the 1-week product trial period.
- Must indicate a neutral/positive intention to use at least one stick variant following the product trial period.
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 time of 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.
- Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
- Participants who have used electronic nicotine delivery system (ENDS), nicotine pouches, HTP or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, other combustible tobacco/nicotine 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.
- Employee of a company that manufactures tobacco or HTPs.
- Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or HTPs.
- Have taken part in a tobacco/nicotine research study in the past 30 days.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: HTP Device 1
HTP Device (One Piece) with two menthol and two tobacco stick variants
|
Tobacco Flavor #1
Tobacco Flavor #2
Menthol #1
Menthol #2
|
|
Aktiv komparator: HTP Device 2
HTP Device (Two Piece) with two menthol and two tobacco stick variants
|
Tobacco Flavor #1
Tobacco Flavor #2
Menthol #1
Menthol #2
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 7 days
|
7 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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.
Tidsram: 7 days
|
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.
Tidsram: 3 months
|
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
Tidsram: 3 months
|
3 months
|
|
The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm
Tidsram: 3 months
|
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
Tidsram: 3 months
|
3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 juli 2026
Första postat (Faktisk)
17 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PHI252504
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .