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Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

27. september 2018 opdateret af: Brown University
In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.

Studieoversigt

Detaljeret beskrivelse

We will enroll 60 smokers who will complete four lab sessions and two field assessments. Participants meeting initial eligibility criteria over the phone will complete an in-person screening visit. Breath carbon monoxide and alcohol tests will be collected. Participants will answer questionnaires on the computer and via interview about their tobacco use and medical history. Eligible participants will remain in the lab to complete additional baseline questionnaires and will be given the opportunity to sample alternative tobacco products, such as LCCs, smokeless tobacco, electronic cigarettes, and nicotine replacement.

During the next two lab sessions, participants will complete a behavioral economics assessment, the Experimental Tobacco Marketplace task, designed to simulate purchasing tobacco products online. Participants will be given 'coupons' to obtain tobacco products from the online experimental marketplace. After these lab sessions, participants will be provided with the tobacco products they selected from the online experimental marketplace to use during 3-day field assessments to validate the task. Participants will be told to only use tobacco products provided by the lab during the field assessments. At both lab sessions, participants will complete questionnaires about their tobacco use, mood, and reactions to the alternative tobacco products. At the final lab session, a qualitative interview will be conducted to learn more about the participants' experiences selecting and using tobacco products.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rekruttering
        • Brown University School of Public Health
        • Kontakt:
          • Rachel Denlinger, MPH
        • Ledende efterforsker:
          • Rachel Denlinger, MPH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Ages 18 and older
  2. Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
  3. Self-report smoking a menthol cigarette brand
  4. Must report use of an alternative tobacco product(s) at least once in the past month
  5. Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
  6. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria:

  1. Breath alcohol level > 0.01 ng/ml
  2. Intention to quit smoking in the next 30 days
  3. Self-reported serious medical or psychiatric conditions during the past 12 months including:

    1. heart attack
    2. stroke
    3. angina
    4. blood clots in the arms or legs for which the individual is undergoing active medical treatment
    5. cancer requiring active chemotherapy or radiation therapy
    6. chronic obstructive pulmonary disease
    7. schizophrenia
  4. Pregnant or breastfeeding
  5. CO reading > 80 ppm
  6. Enrollment stratum (white or African-American/black) is full

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Condition 1: All Products
Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, all tobacco products are available in menthol and non-menthol flavors.
Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Andre navne:
  • Condition 1: All Products
  • Condition 2: No menthol LCCs
Andet: Condition 2: No menthol LCCs
Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, the online tobacco marketplace does not include menthol flavored little cigars and cigarillos.
Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Andre navne:
  • Condition 1: All Products
  • Condition 2: No menthol LCCs

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total amount of combusted tobacco purchased in mg of nicotine.
Tidsramme: through study completion, an average of 2-weeks.
How much combusted tobacco is purchased by the participants.
through study completion, an average of 2-weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tobacco Product Demand Curves
Tidsramme: through study completion, an average of 2-weeks.
Purchasing data will be used to generate demand curves for each tobacco product available on the online tobacco marketplace.
through study completion, an average of 2-weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Rachel Denlinger, MPH, Brown University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. juli 2018

Primær færdiggørelse (Forventet)

1. februar 2019

Studieafslutning (Forventet)

1. februar 2020

Datoer for studieregistrering

Først indsendt

26. juli 2018

Først indsendt, der opfyldte QC-kriterier

1. august 2018

Først opslået (Faktiske)

2. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1708001884

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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