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The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke

27. August 2026 aktualisiert von: Alayna Tackett, Ohio State University Comprehensive Cancer Center

Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers

This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.

SECONDARY OBJECTIVES:

I. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.

II. Evaluate the effect of perceived harm on IQOS use behavior.

EXPLORATORY OBJECTIVE:

I. Examine acute changes to pulmonary health associated with IQOS use.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use IQOS HeatSticks (flavor matched to their usual cigarette) as much as desired (ad lib) over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their usual brand cigarette (UBC) ad lib over 60 minutes during laboratory visit 2.

ARM II: Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Rekrutierung
        • Ohio State University Comprehensive Cancer Center
        • Hauptermittler:
          • Alayna P. Tackett, PhD
        • Kontakt:

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

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Adults 21-65 years
  • Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)
  • Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit
  • Willing to bring UBC to each study visit
  • Read, write and speak English

Exclusion Criteria:

  • Current use of other non-combustible nicotine products (e.g., electronic [e]-cigarettes, HTPs; [defined as ≥ 5 days weekly use in the past 30 days])
  • Planning to quit nicotine use and/or use of any smoking cessation medication in the past 30 days
  • Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)
  • Self-reported unstable or significant psychiatric conditions (past/stable conditions will be allowed)
  • History of cardiac event or distress within the past 3 months
  • Deaf, hard of hearing, or have a severe motor disability
  • Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)

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
Sonstiges: Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])
Participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their UBC ad lib over 60 minutes during laboratory visit 2.
Verhalten: Smoking Behavioral Research (IQOS)
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Verhalten: Smoking Behavioral Research (UBC)
Smoke UBC
Sonstiges: Arm II (UBC, IQOS HeatSticks)
Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.
Verhalten: Smoking Behavioral Research (IQOS)
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Verhalten: Smoking Behavioral Research (UBC)
Smoke UBC

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Product Appeal
Zeitfenster: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Participants will complete the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Product Sensory Attributes
Zeitfenster: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Participants will rate sensory attributes using the Appeal and Sensory Quality questionnaire. This questionnaire will ask participants to rate each study product for sensory attributes such as harshness, coolness, sweetness, etc. on a scale of 0 (not at all) - 100 (extremely). Higher scores indicate greater harshness, coolness, sweetness, etc.
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Economic demand breakpoint
Zeitfenster: Minute 60 of product use session
The price point at which a participant is no longer willing to pay for a stick of the study product will be determined by using a cigarette purchase task questionnaire.
Minute 60 of product use session
Satisfaction and psychological reward
Zeitfenster: Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Satisfaction and psychological reward of study product use will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ). The mCEQ asks questions relating to satisfaction of using the study product on a scale from 0 (Not at all) - 6 (Extremely).
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
Abuse Liability Via Puff Topography - Total Smoking Time
Zeitfenster: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Puff Duration
Zeitfenster: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Flow Rate
Zeitfenster: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
Zeitfenster: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Minute 60 of product use session
Abuse Liability Via Puff Topography - Average Puff Volume
Zeitfenster: Minute 60 of product use session
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior.
Minute 60 of product use session
Craving/withdrawal
Zeitfenster: Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session
Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)
Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Spirometry FEV1
Zeitfenster: Minute 0 before start of product use session and minute 60 of product use session
Spirometry will be used to measure forced expiratory volume (FEV1)
Minute 0 before start of product use session and minute 60 of product use session
Spirometry FVC
Zeitfenster: Minute 0 before start of product use session, Minute 60 of product use session
Spirometry will be used to measure forced vital capacity (FVC)
Minute 0 before start of product use session, Minute 60 of product use session
Spirometry FEV1/FVC
Zeitfenster: Minute 0 before start of product use session, Minute 60 of product use session
Spirometry will be used to measure FEV1/FVC
Minute 0 before start of product use session, Minute 60 of product use session
Used filter count
Zeitfenster: Minute 60 of product use session
Will assess the number of study product consumed
Minute 60 of product use session
Harm Perception
Zeitfenster: Minute 60 of product use session
A harm perception questionnaire will be used to assess the relative and absolute perceived harm of IQOS products.
Minute 60 of product use session

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University Comprehensive Cancer Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Alayna P Tackett, PhD, Ohio State University Comprehensive Cancer Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

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)

27. August 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

7. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • OSU-26080
  • U54CA287392 (US NIH Stipendium/Vertrag)
  • NCI-2026-04495 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • STUDY20260624 (Andere Kennung: Ohio State University Comprehensive Cancer Center)

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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