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Kommunikasjon om nikotinreduksjon i sigaretter

3. november 2026 oppdatert av: Lyudmila Popova, Georgia State University

Kommunikasjon om nikotin og forskjellsrisiko ved tobakksprodukter i prioriterte populasjoner

The goal of this clinical trial is to learn how a messaging campaign about reduced nicotine cigarettes and policy, combined with the use of very low nicotine cigarettes (VLNCs), affects smoking behavior and attitudes among adult smokers. The study also aims to assess the efficacy of the messages in different populations, including smokers with past-month serious psychological distress (SPD), low socioeconomic status (SES), and those in neither category.

The primary hypothesis is: exposure to messages in combination with VLNC use will lead to less cigarettes use compared to VLNCs without messages.

Researchers will compare: The effects of receiving VLNCs with messages (treatment group) to receiving VLNCs without messages (control group).

Participants will: Complete a baseline survey and be randomly assigned to one of two groups: treatment (VLNCs + messages) or control (VLNCs only). Attend weekly study visits for surveys, breath samples, and receive supply of VLNCs , either with or without the messaging campaign. Complete brief daily surveys through text messages.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, open label, controlled, two-site study to test the efficacy of a messaging campaign about reduced nicotine cigarettes and policy in combination with the use of very low nicotine cigarettes (VLNCs). Smokers from three groups: with past-month serious psychological distress (SPD), with low socioeconomic status (SES), and in neither category will complete a 1-week baseline and a 4-week study; they will be randomized to one of two conditions:

  1. treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.
  2. control condition, where participants receive VLNCs without exposure to messages.

Message intervention: Messages about VLNCs and reduced nicotine policy will be professionally developed as full-color inserts (small leaflets that will be inserted into cigarette packs given to participants), print ads, and videos. At each weekly visit, participants will see 3-6 messages about VLNCs and reduced nicotine policy (in the treatment condition) or, in the control condition, 3-6 messages unrelated to tobacco (ads for bottled water, which are neutral messages that are unlikely to affect tobacco-related perceptions or behavior). Participants in the treatment conditions will also have inserts in their VLNC cigarette packs.

Baseline visit: Participants will complete a baseline survey, provide expired breath Carbon Monoxide (CO) sample, and receive a 1-week supply of the study cigarettes (full nicotine).

Randomization visit: Participants will be randomized into either the treatment (VLNCs + messages) or control (VLNCs only) condition. Participants will complete questionnaires, provide an expired CO sample, and receive a 14-day supply of VLNCs (either with or without the messages, according to the assigned condition).

Weekly visits: Starting one week after the randomization visit, participants will complete 4 weekly visits at their designated study site. At each visit, they will complete questionnaires, provide an expired CO sample, and receive a 14-day supply of VLNCs (with or without the messages, according to the assigned condition).

Daily logs: Throughout the baseline and 4 weekly study periods, participants will receive daily text messages with links to brief online surveys.

Studietype

Intervensjonell

Registrering (Antatt)

1230

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Lyudmila Popova, Ph.D.
  • Telefonnummer: 404-413-9338
  • E-post: lpopova1@gsu.edu

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
      • Atlanta, Georgia, Forente stater, 30303
        • Rekruttering
        • Georgia State university
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 21+ years
  • Current smoker (self-report as having smoked 100 cigarettes in their lifetime and currently smoking on 27+ days out of past 30, expired breath carbon monoxide [CO] ≥6ppm to assess regular smoking)
  • Can speak, read, and write in English
  • Available for period of study
  • Willing to try novel research cigarettes

Exclusion Criteria:

  • Pregnancy or lactation
  • Member of the same household as a study subject
  • Unwilling to use research cigarettes as part of the trial

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VLNC with message campaign

Participants in this arm will receive VLNCs during weekly visits and be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed advertisements, and videos presented during weekly visits.
Atferdsmessig: VLNC messages

Participants will be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed advertisements, and video materials presented during their weekly visits.
Annen: VLNC only

Participants in this arm will receive VLNCs during weekly visits but will not receive any messaging related to cigarettes or reduced nicotine policy. Instead, they will only be exposed to control messages, such as advertisements for bottled water, during weekly visits.
Atferdsmessig: Control message

Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cigarettes per day
Tidsramme: Week 4 of the trial (post randomization)

Number of cigarettes smoked per day (study and non-study cigarettes).

  • Averaged number of cigarettes smoked based on 7 days' daily logs submitted through text-based survey during the last week of the trial.
  • Response: integer indicating number per day.
Week 4 of the trial (post randomization)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Use of other tobacco products
Tidsramme: Week 4 of the trial (post randomization)

Amount of other combusted (LCCs) and noncombustible (e-cigarettes) products per day.

  • Averaged number of other tobacco products is based on 7 days' daily logs submitted through text-based survey during the last week of the trial.
  • Response: integer indicating number per day.
Week 4 of the trial (post randomization)
Use of cessation medications
Tidsramme: Week 4 of the trial (post randomization)

Use of nicotine replacement therapy or prescription cessation medications in the past 24 hours based on 7 days' daily logs submitted through text-based survey during the last week of the trial. This will be assessed using a multiple-choice question, allowing participants to select all NRT or prescription cessation medications used from a provided list of options.
Week 4 of the trial (post randomization)
Forgoing cigarettes
Tidsramme: Through study completion, up to 4 weeks

One item measures number of times forgoing cigarettes when considering smoking in the past 24 hours based on daily logs submitted through text-based survey from baseline visit to the end of the trial. Response options are: 1 (Never), 2 (Once), 3 (A few times), and 4 (Lots of times), with higher scores representing a better outcome.
Through study completion, up to 4 weeks
Making a quit attempt
Tidsramme: Through study completion, up to 4 weeks

One item measures whether participants have made an attempt to stop smoking (not smoking cigarettes for at least 24 hours) in the past week based on questionnaire completed at weekly in-person visits throughout the trial. Response options: 1 (yes), 2 (no), 3 (don't know).
Through study completion, up to 4 weeks
Perceived risk of smoking VLNCs
Tidsramme: Week 4 of the trial (post randomization)

One item measures perceived likelihood of overall harm to health under conditions of smoking VLNCs based on questionnaire completed at the week 4 visit. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Week 4 of the trial (post randomization)
Self-efficacy to quit
Tidsramme: Week 4 of the trial (post randomization)

Multiple items assess perceptions about strength of confidence in own ability to quit smoking based on questionnaire completed at week 4 visit. Response options range from 1 (not at all) to 7 (extremely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Week 4 of the trial (post randomization)
Intention to quit smoking
Tidsramme: Week 4 of the trial (post randomization)

Multiple items assesses Intentions and motivation to quit smoking in the next month and 6 months based on questionnaire completed at week 4 visit. Response options range from 1 (not at all) to 7 (extremely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Week 4 of the trial (post randomization)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Georgia State University

Samarbeidspartnere

National Cancer Institute (NCI)
Emory University
University of South Carolina

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. september 2025

Primær fullføring (Antatt)

31. januar 2029

Studiet fullført (Antatt)

31. januar 2029

Datoer for studieregistrering

Først innsendt

25. desember 2024

Først innsendt som oppfylte QC-kriteriene

16. januar 2025

Først lagt ut (Faktiske)

22. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H25318
  • R01CA239308 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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