Reduktion af tobaksassocieret lungekræftrisiko: Et randomiseret klinisk forsøg med AB-fri Kava
13. august 2026 opdateret af: University of Florida
Brug af tobak er den førende årsag til mange sygdomme, der kan forebygges, især lungekræft. Baseret på de nationale kræftdata i 2020 har Florida den højeste lungekræftforekomst (18.150 tilfælde) med flest dødsfald (10.580 dødsfald) blandt alle stater i USA. Desværre fortsætter omkring 16 % af de voksne i Florida med at ryge cigaretter på grund af dets vanedannende karakter og den begrænsede succes med nuværende ophørsstrategier. Derfor er der et udækket og presserende behov for nye interventioner for at forbedre succesen med tobaksafvænning. Hvis et sådant indgreb kan reducere tobaksassocieret lungekarcinogenese, vil det være mere ønskeligt. Det ultimative mål med denne undersøgelse er at udvikle en sikker og effektiv kava-baseret intervention for at muliggøre tobaksophør og reducere risikoen for lungekræft, hvilket vil forbedre Floridians sundhed.
Denne undersøgelse vil evaluere overholdelse af en daglig kava-kur blandt aktive rygere, som ikke har til hensigt at holde op med at ryge. Denne undersøgelse vil også undersøge, om kava-brug kan reducere tobaksforbrug og afhængighed, såvel som tobaksassocieret lungecarcinogenese.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Gainesville, Florida, Forenede Stater, 32608
- University of Florida
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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
21 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- voksne på 21 år eller derover
- selvrapporteret rygning mindst 10 cigaretter om dagen i det seneste år uden intention om at holde op
- udløbet kulilteniveau på mere end 8 ppm ved rekruttering
- vilje til at deltage i den foreslåede undersøgelse
- adgang til en funktionel telefon
- forventet tilstedeværelse i undersøgelsens geografiske område i de næste 4 måneder
- ikke i øjeblikket tilmeldt nogen rygestopprogrammer
- kvindelige forsøgspersoner i den fødedygtige alder vil være forpligtet til at praktisere acceptable præventionsmetoder (de acceptable præventionsmetoder omfatter p-piller, præventionsskud, præventionsimplantat, intrauterin anordning [IUD], diafragma og cervikal hætte)
Ekskluderingskriterier:
- diagnosticeret med kræft (bortset fra ikke-melanom hudkræft)
- diagnosticeret med leverdysfunktion eller med tidligere leversygdomme
- niveauer af alanintransaminase, aspartattransaminase, alkalisk phosphatase eller total bilirubin over grænsen for normalområdet ved præscreening
- manglende evne til at afstå fra acetaminophen, alkohol (ikke mere end én drink dagligt via selvrapportering) eller andre potentielt hepatotoksiske stoffer
- brug andre ikke-cigaret nikotinholdige produkter såsom røgfri tobak, cigar eller e-cigaretter
- er gravid eller ammer (ammer) eller i den fødedygtige alder, der planlægger at blive gravid eller uvillig til at bruge tilstrækkelig prævention under undersøgelsen
- deltager svarede "Ja" til et af spørgsmålene 1 til 4, eller nægter at svare
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo kontrol
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Deltagerne på denne arm vil tage én placebo-kapsel oralt tre gange dagligt i 28 dage.
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Eksperimentel: Kava Intervention
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Deltagere på denne arm vil tage en kava-kapsel (hver kapsel indeholder 75 mg kavalactoner) oralt tre gange dagligt i 28 dage.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ramzi Salloum, PhD, University of Florida
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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. juni 2022
Primær færdiggørelse (Faktiske)
30. juni 2025
Studieafslutning (Faktiske)
30. juni 2025
Datoer for studieregistrering
Først indsendt
21. september 2021
Først indsendt, der opfyldte QC-kriterier
5. oktober 2021
Først opslået (Faktiske)
18. oktober 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Kava
- OCR40933 (Anden identifikator: University of Florida)
- IRB202101885 (Anden identifikator: University of Florida IRB-01)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
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 .