nctId: NCT06356610 id: ALCS-REG-23-08-HT briefTitle: Pharmacokinetic and Subjective Effects of Heated Tobacco Products overallStatus: RECRUITING date: 2024-02-06 date: 2024-09 date: 2025-06 date: 2024-04-10 date: 2024-04-10 name: Altria Client Services LLC class: INDUSTRY name: Celerion 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). conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA 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 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 count: 60 type: ESTIMATED name: Test Product A name: Test Product B name: Test Product C name: Test Product D name: Reference Product E name: Reference Product F measure: Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement measure: Product Liking of Heated Tobacco Products (HTP) measure: Tobacco Nicotine Withdrawal Questionnaire measure: Direct Effects of Product Questionnaire measure: Use the Product Again Questionnaire measure: Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette measure: Modified Cigarette Evaluation Questionnaire - HTP measure: Modified Cigarette Evaluation Questionnaire-NRT measure: Product Use for HTP-Units Dispensed measure: Product Use for UBCC-Units Dispensed measure: Product Use for Nicotine Gum-Units Dispensed measure: Product Use for HTP-Puff Count measure: Product Use for UBCC-Puff Count measure: Physiological Heart Rate (HR) Assessment-HTP measure: Physiological Heart Rate (HR) Assessment-UBCC measure: Physiological Heart Rate (HR) Assessment-Nicotine Gum sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States name: Mark Adams, MD role: CONTACT phone: 859-264-8999 email: Mark.adams@amrllc.com lat: 37.98869 lon: -84.47772 facility: QPS Bio-Kinetic status: RECRUITING city: Springfield state: Missouri zip: 65802 country: United States name: Donald W Burkindine, DO role: CONTACT phone: 417-893-6161 email: donald.burkindine@qps.com lat: 37.21533 lon: -93.29824 facility: Alliance for Multispecialty Research, LLC status: RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: William Smith, MD role: CONTACT phone: 865-305-9100 email: william.smith@amrllc.com lat: 35.96064 lon: -83.92074 hasResults: False