[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06988371":3,"trial-entities:NCT06988371":93,"trial-summary:NCT06988371":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":55,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":91,"see_also_links":92},"NCT06988371","99596","Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace","ENROLLING_BY_INVITATION","2026-08-29","2026-07","2026-07-27","2025-08-18","Bethany Shorey Fennell, PhD","OTHER",false,"The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.","After granting informed consent, participants will complete the single assessment.\n\nFirst, investigators will collect information from participants on personal characteristics, substance use patterns and addiction severity, and behavioral and cognitive tasks that measure components of our behavioral economic model of product valuation.\n\nExperimental Tobacco Marketplace. In this procedure, participants will complete purchasing scenarios in a realistic tobacco\u002Fnicotine product marketplace to model and examine the impact of each of the proposed tobacco product regulations. Participants will be seated in front of a computer to access a simulated online tobacco marketplace with an interface similar to many online merchants. This will allow participants to browse through the selection of tobacco products and add as many as they desire of each product to the virtual shopping cart. Each product will have the price clearly displayed along with an image and description of the product. The selection of products will vary based on the particular regulatory scenario that is being modeled. In each pricing scenario during each marketplace session, participants will be asked to make nicotine-product purchases sufficient for one week's use from this marketplace. During a purchasing session, the participant will be provided with a virtual budget that matches their actual weekly budget for nicotine\u002Ftobacco products, a procedure our team has shown to generate realistic results. Participants will use that virtual budget to indicate which selection of products they would purchase from those available in the marketplace.",[18,19],"Tobacco Use","Cigarette Use",[21,22,23,24],"tobacco","cigarettes","nondaily smoking","behavioral economics","INTERVENTIONAL",[27],"NA",{"count":29,"type":30},900,"ESTIMATED",[32,39,43],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Reduced nicotine regulatory environment","In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette.",[37,38],"Daily smoking","Nondaily smoking",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Restriction on characterizing flavors in combustible nicotine products","In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available.",[37,38],{"type":33,"name":44,"description":45,"armGroupLabels":46},"Restriction on characterizing flavors in noncombustible nicotine products","In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available.",[37,38],[48,52],{"measure":49,"description":50,"timeFrame":51},"Aggregate behavioral economic demand across all participants under the proposed regulatory environments","Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.","Baseline",{"measure":53,"description":54,"timeFrame":51},"Aggregate behavioral economic substitution across all participants under the proposed regulatory environments","Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.",[56,59],{"measure":57,"description":58,"timeFrame":51},"Hypothetical quantity purchased in purchase tasks","Measures valuation by assessing hypothetical consumption across a price range and across the range of products used by participants in the past 60 days.",{"measure":60,"description":61,"timeFrame":51},"Delay Discounting Tasks","Assesses valuation for future money and nicotine products.","ALL","18 Years",null,true,{"inclusion":67,"exclusion":72,"raw_text":73},[68,69,70,71],"At least 18 years old","Consume cigarettes 4-30 days per month","Have no plans to quit nicotine\u002Ftobacco products","Read and understand English",[],"Inclusion Criteria:\n\n* At least 18 years old\n* Consume cigarettes 4-30 days per month\n* Have no plans to quit nicotine\u002Ftobacco products\n* Read and understand English\n\nExclusion Criteria:",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"University of Kentucky","Lexington","Kentucky","40504","United States",{"lat":85,"lon":86},37.98869,-84.47772,[],[89],{"name":12,"affiliation":79,"role":90},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[19,18],[],{"nct_id":4,"found":65,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This interventional study plans to enroll 900 participants. It involves comparing how people respond to different regulatory environments in a simulated marketplace.","completed","Understanding Tobacco Regulations for Smokers","This study is looking at how different tobacco regulations might affect adults who smoke cigarettes, both daily and occasionally. Researchers want to see how people react when certain products aren't available in a simulated online store. Specifically, they're testing environments where only reduced nicotine content cigarettes are available, or where flavored combustible (burnable) or noncombustible (like vapes) nicotine products are restricted. The goal is to understand how these changes influence purchasing decisions. You can join if you are at least 18 years old, smoke cigarettes 4-30 days a month, don't plan to quit, and can read English. The study aims to understand how people change their buying habits under these different rules.","Not specified.",112,"You will complete online surveys and tests, and participate in online shopping sessions in a simulated Experimental Tobacco Marketplace. This is a single assessment.","Not stated in the trial record.",[],"v2"]