[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07688304":3,"trial-entities:NCT07688304":140,"trial-summary:NCT07688304":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":69,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":107,"locations":110,"central_contacts":127,"overall_officials":132,"references":135,"see_also_links":136},"NCT07688304","OSU-26080","The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke","Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers","NOT_YET_RECRUITING","2027-10","2026-06","2026-07-07","2026-07","Ohio State University Comprehensive Cancer Center","OTHER",false,"This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.","PRIMARY OBJECTIVES:\n\nI. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.\n\nII. Evaluate the effect of perceived harm on IQOS use behavior.\n\nEXPLORATORY OBJECTIVE:\n\nI. Examine acute changes to pulmonary health associated with IQOS use.\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM 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.\n\nARM 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.",[19],"Tobacco",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Smoking Behavioral Research (IQOS)","Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)",[33,34],"Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])","Arm II (UBC, IQOS HeatSticks)",{"type":29,"name":36,"description":37,"armGroupLabels":38},"Smoking Behavioral Research (UBC)","Smoke UBC",[33,34],[40,44,47,51,54,57,59,61,63,65],{"measure":41,"description":42,"timeFrame":43},"Product Appeal","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",{"measure":45,"description":46,"timeFrame":43},"Product Sensory Attributes","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.",{"measure":48,"description":49,"timeFrame":50},"Economic demand breakpoint","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",{"measure":52,"description":53,"timeFrame":43},"Satisfaction and psychological reward","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).",{"measure":55,"description":56,"timeFrame":50},"Abuse Liability Via Puff Topography - Total Smoking Time","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.",{"measure":58,"description":56,"timeFrame":50},"Abuse Liability Via Puff Topography - Average Puff Duration",{"measure":60,"description":56,"timeFrame":50},"Abuse Liability Via Puff Topography - Average Flow Rate",{"measure":62,"description":56,"timeFrame":50},"Abuse Liability Via Puff Topography - Average Inter-Puff Interval",{"measure":64,"description":56,"timeFrame":50},"Abuse Liability Via Puff Topography - Average Puff Volume",{"measure":66,"description":67,"timeFrame":68},"Craving\u002Fwithdrawal","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",[70,74,78,81,84],{"measure":71,"description":72,"timeFrame":73},"Spirometry FEV1","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",{"measure":75,"description":76,"timeFrame":77},"Spirometry FVC","Spirometry will be used to measure forced vital capacity (FVC)","Minute 0 before start of product use session, Minute 60 of product use session",{"measure":79,"description":80,"timeFrame":77},"Spirometry FEV1\u002FFVC","Spirometry will be used to measure FEV1\u002FFVC",{"measure":82,"description":83,"timeFrame":50},"Used filter count","Will assess the number of study product consumed",{"measure":85,"description":86,"timeFrame":50},"Harm Perception","A harm perception questionnaire will be used to assess the relative and absolute perceived harm of IQOS products.","ALL","21 Years","65 Years",true,{"inclusion":92,"exclusion":98,"raw_text":106},[93,94,95,96,97],"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",[99,100,101,102,103,104,105],"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\u002For 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\u002Fstable 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)","Inclusion Criteria:\n\n* Adults 21-65 years\n* Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)\n* Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit\n* Willing to bring UBC to each study visit\n* Read, write and speak English\n\nExclusion Criteria:\n\n* 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\\])\n* Planning to quit nicotine use and\u002For use of any smoking cessation medication in the past 30 days\n* Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)\n* Self-reported unstable or significant psychiatric conditions (past\u002Fstable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Deaf, hard of hearing, or have a severe motor disability\n* Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)",[108,109],"ADULT","OLDER_ADULT",[111],{"facility":13,"city":112,"state":113,"zip":114,"country":115,"contacts":116,"geoPoint":124},"Columbus","Ohio","43210","United States",[117,122],{"name":118,"role":119,"phone":120,"email":121},"Alayna P. Tackett, PhD","CONTACT","844-744-2447","Tackett-Lab@osumc.edu",{"name":118,"role":123},"PRINCIPAL_INVESTIGATOR",{"lat":125,"lon":126},39.96118,-82.99879,[128],{"name":129,"role":119,"phone":130,"email":131},"The Ohio State University Comprehensive Cancer Center","800-293-5066","OSUCCCClinicaltrials@osumc.edu",[133],{"name":134,"affiliation":13,"role":123},"Alayna P Tackett, PhD",[],[137],{"label":138,"url":139},"The Jamesline","http:\u002F\u002Fcancer.osu.edu",{"nct_id":4,"conditions":141,"biomarkers":142},[19],[],{"nct_id":4,"found":90,"summary":144,"prompt_version":154},{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is an interventional study with 30 participants, randomized into two groups. Each group will try both IQOS HeatSticks and their usual brand of cigarettes.","completed","Study on IQOS Heated Tobacco Products for Adults Who Smoke","This study is looking at how adults who smoke cigarettes experience IQOS heated tobacco products compared to their usual cigarettes. Researchers want to understand how appealing IQOS is and what sensory effects (like taste or feel) it has. You would use IQOS HeatSticks, matched to your usual cigarette flavor, and also smoke your usual brand of cigarettes during study visits. The study aims to see how these products are used and how they affect your senses. This study is for adults aged 21-65 who smoke at least five days a week. The study plans to enroll 30 participants, but its current recruitment status is unclear.","The primary measurements are taken at 5, 35, and 60 minutes during the product use sessions.",105,"You would attend two laboratory visits, at least 48 hours apart. During each visit, you would use either IQOS HeatSticks or smoke your usual brand of cigarettes for 60 minutes. You also need to abstain from nicotine for 12 hours before each visit and bring your usual brand of cigarettes.","Not stated in the trial record.",[],"v2"]