- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03589599
Understanding the Effect of Flavor on Hookah Smoking Experience
30. juli 2020 oppdatert av: Wasim Maziak, phd, Florida International University
Understanding Tobacco Flavor Effects on Waterpipe Smokers' Experiences and Exposures
This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure.
Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users.
Findings from this study will help informing flavor-based product regulation by the FDA.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Waterpipe (WP) tobacco smoking (a.k.a.
hookah, shisha, narghile) is increasing rapidly in the United States (US), particularly among young people.
Evidence suggests that WP smoking can lead to dependence, other tobacco use, and many of the known smoking-related diseases including cancer, cardiovascular disease and adverse pregnancy outcomes.
These alarming trends led the Food and Drug Administration (FDA) in 2014 to propose including the WP under its regulatory authority, allowing the FDA to apply evidence-based regulatory approaches to control WP spread in the US.
Given the salience of flavored tobacco in shaping the "WP experience", regulating WP tobacco flavor represents a promising approach for the FDA to curb WP use among US youth.
This project aims to assist the FDA in these efforts by providing answers to specific questions pertinent to the potential of WP regulation through flavor.
These include: - How would flavor manipulation affect the smoking experience and satisfaction of WP users at different stages of their smoking trajectory - How would smoking non-preferred flavor or unflavored WP tobacco reflects on smokers' exposure to nicotine, and dependence; and - How would flavor manipulation influence puffing behavior and exposure to toxicants such as carbon monoxide (CO) among WP smokers.
Answers to these questions will help the FDA predict the impact of flavor regulation on WP experimentation and continued use.
In this study, investigators will use clinical laboratory methods to answer these questions.
Two groups of WP smokers will be recruited based on their use frequency: low (Beginners) vs. high frequency (Experienced) smokers (72/group; total 144; age 18-30).
Each participant will undergo 2 WP smoking sessions that differ by flavor (preferred flavor; unflavored), while measurement of WP satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted.
The response of WP smokers at different stages of their WP smoking trajectory (Beginners vs. Experienced) to flavor manipulation, will allow to predict the effect of limiting flavors on a wide range of WP smokers.
This project promises to provide the first evidence to guide the FDA in terms of the potential of regulating WP flavored tobacco on WP uptake and use in the US.
Studietype
Intervensjonell
Registrering (Faktiske)
144
Fase
- Ikke aktuelt
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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Miami, Florida, Forente stater, 33199
- Florida International University
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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
18 år til 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Generally healthy individuals (determined by physical examination).
- Age of 18-30 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- WP smokers who smoke flavored WP tobacco.
- Have abstained from WP for 12 hours prior to each session
Exclusion Criteria:
- Report smoking cigarettes regularly (> 5 cigarettes/month in the past year).
- Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
- Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
- Individuals with self-reported history of chronic disease or psychiatric conditions.
- Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Flavored tobacco
All participants will be completing a lab visit where they smoke flavored waterpipe tobacco ad lib for up to 45 min.
|
Effects of flavored tobacco
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Eksperimentell: Non-flavored tobacco
All participants will be completing a lab visit where they smoke non-flavored waterpipe tobacco ad lib for up to 45 min.
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Effects of non-flavored tobacco
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Plasma nicotine
Tidsramme: During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period
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Change in plasma nicotine level
|
During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Minnesota Nicotine Abstinensskala
Tidsramme: Ved deltakernes 1. og 2. besøk. Spørreskjemaet vil bli administrert 2 ganger i hver røykeøkt: før og etter en ca. 45-minutters ad lib-bruksperiode.
|
Denne skalaen brukes til å vurdere i hvilken grad produktbruk reduserer tobakksavholdssymptomer, og består av 11 elementer med en score på 0 - 100.
Disse elementene presenteres som Visual Analog Scale med element (mål) sentrert over en horisontal linje forankret til venstre med ikke i det hele tatt og til høyre med ekstremt.
|
Ved deltakernes 1. og 2. besøk. Spørreskjemaet vil bli administrert 2 ganger i hver røykeøkt: før og etter en ca. 45-minutters ad lib-bruksperiode.
|
Puff topography
Tidsramme: During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
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measurement of puffing behavior
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During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period)
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Tiffany-Drobes Questionnaire of Smoking Urges
Tidsramme: During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
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This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).
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During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
|
Carbon monoxide levels
Tidsramme: During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
|
Change in carbon monoxide levels (in parts per mission)
|
During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period
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Harm perception
Tidsramme: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
|
This scale assess waterpipe harm perception and measure perceptions of waterpipe relative risk compared to cigarettes.
The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).
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During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
|
Duke Sensory Questionnaire
Tidsramme: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
|
This scale assess participants sensory experience of the inhaled product.
The scale has nine items.
All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
|
During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
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The Cigarette/WP Evaluation Scale (WES)
Tidsramme: During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
|
This scale assesses participants' perception of the smoked waterpipe, The scale has 11 items.
All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
|
During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Heart rate
Tidsramme: During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
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Change in heart rate, measured in beats per minute
|
During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
|
Blood pressure
Tidsramme: During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session
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Change in blood pressure, measured in mm/hg
|
During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
21. mars 2017
Primær fullføring (Faktiske)
30. juni 2020
Studiet fullført (Faktiske)
30. juni 2020
Datoer for studieregistrering
Først innsendt
11. juni 2018
Først innsendt som oppfylte QC-kriteriene
5. juli 2018
Først lagt ut (Faktiske)
18. juli 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- R01DA042477 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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