Redusere tobakksassosiert lungekreftrisiko: En randomisert klinisk prøve av AB-fri Kava
13. august 2026 oppdatert av: University of Florida
Tobakksbruk er den viktigste årsaken til mange sykdommer som kan forebygges, spesielt lungekreft. Basert på nasjonale kreftdata i 2020, har Florida den høyeste lungekreftforekomsten (18 150 tilfeller) med flest dødsfall (10 580 dødsfall) blant alle delstatene i USA. Dessverre fortsetter rundt 16 % av voksne i Florida å røyke sigaretter på grunn av dens vanedannende natur og den begrensede suksessen til nåværende sluttstrategier. Derfor er det et udekket og presserende behov for nye intervensjoner for å forbedre suksessen med tobakksavvenning. Hvis en slik intervensjon kan redusere tobakksassosiert lungekarsinogenese, vil det være mer ønskelig. Det endelige målet med denne studien er å utvikle en sikker og effektiv kava-basert intervensjon for å muliggjøre tobakksavvenning og redusere risikoen for lungekreft, noe som vil forbedre helsen til Floridians.
Denne studien vil evaluere overholdelse av et daglig kava-regime blant aktive røykere som ikke har til hensikt å slutte å røyke. Denne studien skal også undersøke om kavabruk kan redusere tobakksbruk og avhengighet, samt tobakksassosiert lungekarsinogenese.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Gainesville, Florida, Forente stater, 32608
- University of Florida
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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 til 99 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- voksne i alderen 21 år eller eldre
- selvrapportert røyking minst 10 sigaretter/dag det siste året uten intensjon om å slutte
- utløpt karbonmonoksidnivå på mer enn 8 ppm ved rekruttering
- vilje til å delta i den foreslåtte studien
- tilgang til en funksjonell telefon
- forventet tilstedeværelse i studiens geografiske område de neste 4 månedene
- ikke for øyeblikket påmeldt noen røykesluttprogrammer
- kvinnelige forsøkspersoner i fertil alder vil bli pålagt å praktisere akseptable prevensjonsmetoder (de akseptable prevensjonsmetodene inkluderer p-piller, prevensjonssprøyte, implantat for prevensjon, intrauterin apparat [IUD], diafragma og livmorhalshette)
Ekskluderingskriterier:
- diagnostisert med kreft (annet enn ikke-melanom hudkreft)
- diagnostisert med leverdysfunksjon eller med tidligere leversykdommer
- nivåer av alanintransaminase, aspartattransaminase, alkalisk fosfatase eller total bilirubin over grensen for normalområdet ved forhåndsscreening
- manglende evne til å avstå fra acetaminophen, alkohol (ikke mer enn én drink daglig via egenrapportering), eller andre potensielt hepatotoksiske stoffer
- bruk andre nikotinholdige produkter som ikke inneholder sigaretter som røykfri tobakk, sigar eller e-sigaretter
- er gravid eller ammer (ammer) eller i fertil alder planlegger å bli gravid eller uvillig til å bruke tilstrekkelig prevensjon under studien
- deltaker svarte "Ja" på noen av spørsmålene 1 til 4, eller nekter å svare
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebokontroll
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Deltakere på denne armen vil ta en placebokapsel oralt tre ganger daglig i 28 dager.
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Eksperimentell: Kava Intervensjon
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Deltakere på denne armen vil ta en kava-kapsel (hver kapsel inneholder 75 mg kavalaktoner) oralt tre ganger daglig i 28 dager.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Urinary Total Nicotine Equivalents
Tidsramme: at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
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Measure urinary total nicotine equivalents (TNE).
TNE is the sum of nicotine and its metabolites in a participant's urine.
TNE was measured at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
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at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Reinforcing Effects of Smoking
Tidsramme: At baseline (Day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after starting treatment)
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Determine if participants experience reinforcing effects of smoking using the Modified Cigarette Evaluation Questionnaire.
Subjects respond with a whole number numerical value from 1 to 7 for each item.
The item responses are used to determine 5 scores: smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations and craving reduction.
Each score is either the response to a single item (for the enjoyment of respiratory tract sensations and craving reduction scores) or is calculated as the mean of multiple individual item responses (for the smoking satisfaction, psychological reward, and aversion scores).
Possible values for each score range from a minimum of 1 and a maximum of 7. A higher value is worse for the smoking satisfaction, psychological reward and craving reduction scores.
A lower value is worse for the aversion score.
A higher score for the respiratory tract sensations score means greater enjoyment of respiratory tract sensations.
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At baseline (Day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after starting treatment)
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Participant Reported Number of Cigarettes Smoked Weekly
Tidsramme: At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Determine the participant reported number of cigarettes smoked weekly.
The number of cigarettes smoked was measured by having participants document how many cigarettes they smoked in the past week on a calendar.
Participants completed this at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
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At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Participant Urge to Smoke
Tidsramme: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Measure participant urge to smoke using the Brief Questionnaire on Smoking Urges (QSU-Brief).
The QSU-Brief is a 10-item scale, assessing the features of craving, including the anticipation of relief of nicotine withdrawal, anticipation of positive outcomes of smoking, desire to smoke, and intention to smoke.
Participants respond with a score from 1 (best) to 7 (worst) for each item.
Possible total scores range from 10 to 70, with a higher score meaning a greater urge to smoke.
Participants completed the QSU-Brief at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
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At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Nicotine Dependency
Tidsramme: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Measure participant nicotine dependency using the Fagerström Test for Nicotine Dependence (FTND).
The FTND is a 6-item scale measuring the level of nicotine dependency or addiction.
It assesses how soon tobacco use begins each day, which cigarettes during the day a person could do without, how smokers cope in places where they cannot smoke, and how frequently and how deeply they smoke.
Responses for each item are given either 0 points or 1 point for 4 items and 0-3 points for 2 items, with more points meaning a greater nicotine dependency.
Possible total scores range from 0 to 10 points, with a higher score meaning a greater nicotine dependency.
Participants completed the FTND at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
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At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Perceived Stress
Tidsramme: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Measure participant perceived stress using the Perceived Stress Scale (PSS).
The PSS is a 10-item scale measuring the perception of stress.
It is a measure of the degree to which situations in one's life are appraised as stressful.
The scale also includes a number of direct queries about current levels of experienced stress.
Participants respond to each item with a score of 0 ("never") to 4 ("very often").
A higher score is worse for the 6 items assessing negative outcomes, such as how often participants felt nervous and stressed and a lower score is worse for the 4 items assessing positive outcomes, such as how often participants felt on top of things.
Possible total scores range from 0 to 40, with a higher score meaning higher perceived stress.
Participants completed the PSS at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
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At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Severity of Insomnia
Tidsramme: At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Measure severity of participant insomnia using the Insomnia Severity Scale.
The Insomnia Severity Scale is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.
Participants respond to each item with a score of 0 (best) to 4 (worst).
Possible total scores range from 0 to 28, with a higher score meaning more severe insomnia.
Participants completed the Insomnia Severity Scale at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
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At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
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Compliance Score Percentage
Tidsramme: At end of treatment (28 days after starting treatment)
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Evaluate subject compliance with the kava intervention, as measured by the compliance score percentage.
The compliance score percentage was calculated by dividing the total number of kava or placebo capsules actually consumed across all visits by the total number of kava or placebo capsules expected to be consumed across all visits and multiplying the result by 100.
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At end of treatment (28 days after starting treatment)
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Participant Compliance Status
Tidsramme: At end of treatment (28 days after starting treatment)
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Determine participant compliance status, defined as whether the number of kava or placebo capsules expected to be returned matched the number of kava or placebo capsules actually returned by a participant across all visits, with "Yes" indicating a match and "No" indicating a mismatch.
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At end of treatment (28 days after starting treatment)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ramzi Salloum, PhD, University of Florida
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
- Xing C, Malaty J, Malham MB, Nehme AMA, Freeman B, Huo Z, Firpi-Morrel R, Salloum RG. Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava. Trials. 2023 Jan 18;24(1):36. doi: 10.1186/s13063-023-07081-x.
- Freeman B, Bian T, Xu G, Wheeler M, Fujioka N, Malaty J, Orlando FA, Braithwaite D, Salloum RG, Bruijnzeel AW, Zhang W, Xing C. Assessing the physiological relevance of the bioactivation of tobacco-specific carcinogen NNK and its metabolite NNAL: quantitative analyses of hydrolysis products from their protein adducts under different carcinogen exposure conditions. Carcinogenesis. 2026 Apr 9;47(2):bgag031. doi: 10.1093/carcin/bgag031.
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)
9. juni 2022
Primær fullføring (Faktiske)
30. juni 2025
Studiet fullført (Faktiske)
30. juni 2025
Datoer for studieregistrering
Først innsendt
21. september 2021
Først innsendt som oppfylte QC-kriteriene
5. oktober 2021
Først lagt ut (Faktiske)
18. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Kava
- OCR40933 (Annen identifikator: University of Florida)
- IRB202101885 (Annen identifikator: University of Florida IRB-01)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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