- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03612349
Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rekruttering
- Brown University School of Public Health
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Ta kontakt med:
- Rachel Denlinger, MPH
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Hovedetterforsker:
- Rachel Denlinger, MPH
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
Andre navn:
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Annen: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total amount of combusted tobacco purchased in mg of nicotine.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Tobacco Product Demand Curves
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rachel Denlinger, MPH, Brown University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1708001884
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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