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Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability

3. Juni 2026 aktualisiert von: Yoojin Cho, Ohio State University Comprehensive Cancer Center
This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference. Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period. The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods.

In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory perception, craving) are assessed before and after smoking, followed by the Cigarette Purchase Task (CPT). Participants then complete brief surveys three times daily for one week to capture product use and subjective effects in the natural environment.

In Phase 2, participants return for three additional laboratory visits, each separated by at least 48 hours, and smoke one of three blinded study products in a randomized order; study coordinators remain blinded. Each visit follows the Phase 1 procedures (standardized smoking session, topography, serial blood sampling, and subjective ratings). After smoking, participants complete the CPT and the Cross-Price Elasticity Task (CPET), in which the price of UBMC increases while the study product remains fixed, characterizing substitutability.

In Phase 3, participants identify their preferred study product and receive a one-week supply, with instructions to use it exclusively in place of their UBMC. They continue the three-times-daily survey schedule throughout the week. The phase concludes with a final 2-hour laboratory visit including a remaining-cigarette count and the Progressive Ratio Task (PRT), providing a measure of the relative reinforcing value of the preferred study product vs. UBMC.

Studientyp

Interventionell

Einschreibung (Geschätzt)

48

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
        • Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Yoo Jin Cho, PhD, MPH

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:

  • Aged 21 years or older
  • Currently smoke cigarettes daily (≥ 5 cigarettes/day) for at least the past 6 months, and their usual brand is menthol cigarettes
  • Willing to provide informed consent
  • Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit
  • Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments)
  • Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product
  • Able to read, speak, and understand English

Exclusion Criteria:

  • Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis)
  • History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months
  • Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
  • Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days
  • Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months
  • Self-reported difficulty with blood draws

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Study Cigarette A
Participants smoke one Study Cigarette A during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.
Verhalten: Biospecimen Collection
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Verhalten: Questionnaire Administration
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
Verhalten: Cigarette Purchase Task
A behavioral economic task administered after each laboratory smoking session. Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
Verhalten: Cross-Price Elasticity Task
A behavioral economic task administered after each Phase 2 smoking session. Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Verhalten: Daily Diary Surveys
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
Verhalten: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.
Experimental: Study Cigarette B
Participants smoke one Study Cigarette B during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.
Verhalten: Biospecimen Collection
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Verhalten: Questionnaire Administration
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
Verhalten: Cigarette Purchase Task
A behavioral economic task administered after each laboratory smoking session. Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
Verhalten: Cross-Price Elasticity Task
A behavioral economic task administered after each Phase 2 smoking session. Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Verhalten: Daily Diary Surveys
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
Verhalten: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.
Experimental: Study Cigarette C
Participants smoke one Study Cigarette C during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling. Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session. Order of exposure to Study Cigarettes A, B, and C is randomized.
Verhalten: Biospecimen Collection
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Verhalten: Questionnaire Administration
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
Verhalten: Cigarette Purchase Task
A behavioral economic task administered after each laboratory smoking session. Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
Verhalten: Cross-Price Elasticity Task
A behavioral economic task administered after each Phase 2 smoking session. Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Verhalten: Daily Diary Surveys
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
Verhalten: Progressive Ratio Task
A concurrent choice task administered at the final laboratory visit.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Plasma nicotine (Cmax)
Zeitfenster: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
During Phase 1 and 2 smoking sessions, assessed up to 3 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Appeal ratings (Labeled Hedonic Scale)
Zeitfenster: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
The Labeled Hedonic Scale (LHS) is a self-reported measure of appeal. Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Puff topography
Zeitfenster: During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
Puffing topography will be summarized with total puff count, average puff duration, average inter-puff interval, average puff volume, total puff volume, average flow rate, and peak flow rate.
During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
Sensory effects (general Labeled Magnitude Scale)
Zeitfenster: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
The general Labeled Magnitude Scale (gLMS) is a 5-item self-report measure of sensory effects. Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Nicotine craving and withdrawal (Questionnaire of smoking urges)
Zeitfenster: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Craving relief will be assessed using Questionnaire of Smoking Urges (QSU). The QSU is made up of 10 statements about the respondent's feelings and thoughts about desire to smoke cigarettes as they are completing the questionnaire. The scoring comprises of two factors, each the sum of 5 items. The scores for each factor range from 5-35, and the total score (the sum of all 10 items) ranges from 10-70. For each factor and for the total score, higher scores indicate more severe urges.
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Zeitfenster: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Withdrawal will be assessed using Minnesota Nicotine Withdrawal Scale (MNWS). Items are rated on a 5-point scale from 0 (none) to 4 (severe). MNWS is the sum of 8 items with scores ranging from 0 to 32 with higher scores indicating more severe overall withdrawal.
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
Zeitfenster: During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
MNWS-Craving will be calculated which uses a single item from the MNWS that is scored from 0-4 with higher scores indicating greater craving.
During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
Breakpoint
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).
Post Phase 2 smoking sessions, assessed up to 3 weeks
Demand intensity (Q0)
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).
Post Phase 2 smoking sessions, assessed up to 3 weeks
Maximum financial expenditure on cigarettes (Omax)
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.
Post Phase 2 smoking sessions, assessed up to 3 weeks
Price at which expenditure is maximized (Pmax)
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the price at which expenditure is maximized.
Post Phase 2 smoking sessions, assessed up to 3 weeks
Demand elasticity (alpha)
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).
Post Phase 2 smoking sessions, assessed up to 3 weeks
Cross-over price
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).
Post Phase 2 smoking sessions, assessed up to 3 weeks
Progressive ratio task
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
The proportion of puffs allocated to the study products versus usual brand menthol cigarettes (UBMC) will be measured with the Progressive Ratio Task (PRT).
Post Phase 2 smoking sessions, assessed up to 3 weeks
Preferred product selection
Zeitfenster: Post Phase 2 smoking sessions, assessed up to 3 weeks
Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.
Post Phase 2 smoking sessions, assessed up to 3 weeks
Product substitution
Zeitfenster: 1 week Phase 3 substitution period
Substitution assessed via use behavior during Phase 3 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.
1 week Phase 3 substitution period

Mitarbeiter und Ermittler

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

Sponsor

Ohio State University Comprehensive Cancer Center

Mitarbeiter

National Institute on Drug Abuse (NIDA)

Ermittler

  • Hauptermittler: Yoo Jin Cho, PhD, MPH, 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 (Geschätzt)

22. Juni 2026

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

30. September 2029

Studienanmeldedaten

Zuerst eingereicht

27. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OSU-25014
  • K01DA061444 (US NIH Stipendium/Vertrag)
  • NCI-2026-01493 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data will be archived through the National Addiction & HIV Data Archive Program (NAHDAP) at the Inter-university Consortium for Political and Social Research (ICPSR). Access requires a Restricted Data Use Agreement.

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

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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