- ICH GCP
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- Klinische proef NCT03612349
Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rachel Denlinger, MPH
- Telefoonnummer: 401-262-0316
- E-mail: rachel_denlinger@brown.edu
Studie Locaties
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Werving
- Brown University School of Public Health
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Contact:
- Rachel Denlinger, MPH
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Hoofdonderzoeker:
- Rachel Denlinger, MPH
-
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Ages 18 and older
- Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
- Self-report smoking a menthol cigarette brand
- Must report use of an alternative tobacco product(s) at least once in the past month
- Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
- Speak, comprehend, and read English well enough to complete study procedures
Exclusion Criteria:
- Breath alcohol level > 0.01 ng/ml
- Intention to quit smoking in the next 30 days
Self-reported serious medical or psychiatric conditions during the past 12 months including:
- heart attack
- stroke
- angina
- blood clots in the arms or legs for which the individual is undergoing active medical treatment
- cancer requiring active chemotherapy or radiation therapy
- chronic obstructive pulmonary disease
- schizophrenia
- Pregnant or breastfeeding
- CO reading > 80 ppm
- Enrollment stratum (white or African-American/black) is full
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
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Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Andere namen:
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Ander: 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.
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Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Total amount of combusted tobacco purchased in mg of nicotine.
Tijdsspanne: through study completion, an average of 2-weeks.
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How much combusted tobacco is purchased by the participants.
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through study completion, an average of 2-weeks.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Tobacco Product Demand Curves
Tijdsspanne: through study completion, an average of 2-weeks.
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Purchasing data will be used to generate demand curves for each tobacco product available on the online tobacco marketplace.
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through study completion, an average of 2-weeks.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rachel Denlinger, MPH, Brown University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1708001884
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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