- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03589599
Understanding the Effect of Flavor on Hookah Smoking Experience
30. Juli 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
144
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Florida
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Miami, Florida, Vereinigte Staaten, 33199
- Florida International University
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 30 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Plasma nicotine
Zeitfenster: 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
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Minnesota Nikotinentzugsskala
Zeitfenster: Beim 1. und 2. Besuch der Teilnehmer. Der Fragebogen wird 2 Mal in jeder Rauchersitzung verabreicht: vor und nach einer etwa 45-minütigen Ad-lib-Anwendungsperiode.
|
Diese Skala wird verwendet, um zu beurteilen, inwieweit der Produktkonsum die Symptome der Tabakabstinenz reduziert, und besteht aus 11 Punkten, die mit 0–100 Punkten bewertet werden.
Diese Items werden als visuelle Analogskala dargestellt, wobei das Item (Maß) über einer horizontalen Linie zentriert ist, die auf der linken Seite mit gar nicht und auf der rechten Seite mit extrem verankert ist.
|
Beim 1. und 2. Besuch der Teilnehmer. Der Fragebogen wird 2 Mal in jeder Rauchersitzung verabreicht: vor und nach einer etwa 45-minütigen Ad-lib-Anwendungsperiode.
|
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Puff topography
Zeitfenster: 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
Zeitfenster: 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.
|
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).
|
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
Zeitfenster: 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
|
|
Harm perception
Zeitfenster: 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).
|
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
Zeitfenster: 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)
Zeitfenster: 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.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Heart rate
Zeitfenster: During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
|
Change in heart rate, measured in beats per minute
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During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr
|
|
Blood pressure
Zeitfenster: During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session
|
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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
21. März 2017
Primärer Abschluss (Tatsächlich)
30. Juni 2020
Studienabschluss (Tatsächlich)
30. Juni 2020
Studienanmeldedaten
Zuerst eingereicht
11. Juni 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Juli 2018
Zuerst gepostet (Tatsächlich)
18. Juli 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. August 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. Juli 2020
Zuletzt verifiziert
1. Juli 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- R01DA042477 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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