protocolSection identificationModule nctId: NCT06356610, orgStudyIdInfo id: ALCS-REG-23-08-HT, briefTitle: Pharmacokinetic and Subjective Effects of Heated Tobacco Products, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Altria Client Services LLC, class: INDUSTRY, collaborators name: Celerion, descriptionModule briefSummary: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6)., conditionsModule conditions: Tobacco Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs (2 menthol varieties, Products A and B; 2 tobacco flavor varieties, Products C and D). The study will include participants' UBCC (Product F) and a nicotine gum (Product E) as high and low abuse liability reference products. Sponsor will prepare the randomization schedule. On Day -1 participants will be randomized at 1:1:1:1:1:1 ratio into 1 of 6 sequences as listed below. At least 60 participants will be randomized to ensure approximately 48 completed participants, with approximately 24 menthol and 24 non-menthol cigarette smokers. Participants will be stratified by sex and cigarette type for each of the sequences. A 6x6 Latin Square with the following sequences will be used for the randomization: Sequence 1 = ABFCED Sequence 2 = BCADFE Sequence 3 = CDBEAF Sequence 4 = DECFBA Sequence 5 = EFDACB Sequence 6 = FAEBDC., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Study participants will know when they are using their UBCC (usual brand combustible cigarette) and the nicotine gum. However, participants will not be informed of which Ploom® HTS (heated tobacco stick) product they are using. Participants will not see the stick or device packaging., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Test Product A, interventions name: Test Product B, interventions name: Test Product C, interventions name: Test Product D, interventions name: Reference Product E, interventions name: Reference Product F, outcomesModule primaryOutcomes measure: Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement, primaryOutcomes measure: Product Liking of Heated Tobacco Products (HTP), primaryOutcomes measure: Tobacco Nicotine Withdrawal Questionnaire, primaryOutcomes measure: Direct Effects of Product Questionnaire, primaryOutcomes measure: Use the Product Again Questionnaire, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire - HTP, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire-NRT, primaryOutcomes measure: Product Use for HTP-Units Dispensed, primaryOutcomes measure: Product Use for UBCC-Units Dispensed, primaryOutcomes measure: Product Use for Nicotine Gum-Units Dispensed, primaryOutcomes measure: Product Use for HTP-Puff Count, primaryOutcomes measure: Product Use for UBCC-Puff Count, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-HTP, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-UBCC, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-Nicotine Gum, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alliance for Multispecialty Research, LLC, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts name: Mark Adams, MD, role: CONTACT, phone: 859-264-8999, email: Mark.adams@amrllc.com, geoPoint lat: 37.98869, lon: -84.47772, locations facility: QPS Bio-Kinetic, status: RECRUITING, city: Springfield, state: Missouri, zip: 65802, country: United States, contacts name: Donald W Burkindine, DO, role: CONTACT, phone: 417-893-6161, email: donald.burkindine@qps.com, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Alliance for Multispecialty Research, LLC, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: William Smith, MD, role: CONTACT, phone: 865-305-9100, email: william.smith@amrllc.com, geoPoint lat: 35.96064, lon: -83.92074, hasResults: False