[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631687":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":48,"centralContacts":52,"locations":58,"responsibleParty":73,"collaborators":34,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":34,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":34,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Ohio State University Comprehensive Cancer Center","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Small particle size oral nicotine pouches","EXPERIMENTAL","CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.\n\nSWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.",[13,14,15,16],"Procedure: Biospecimen Collection","Drug: Nicotine Oral Pouch","Other: Survey Administration","Other: Text Message-Based Navigation Intervention",{"label":18,"type":10,"description":19,"interventionNames":20},"Variable particle size oral nicotine pouches","CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.\n\nSWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.",[13,14,15,16],[22,29,35,38,42],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,18],[28],"Biological Sample Collection",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Nicotine Oral Pouch","Insert small particle size ONP",[9],null,{"type":30,"name":31,"description":36,"armGroupLabels":37,"otherNames":34},"Insert variable particle size ONP",[18],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Survey Administration","Ancillary studies",[9,18],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Text Message-Based Navigation Intervention","Receive text with a link to daily diary surveys",[9,18],[47],"Automated Text Message-Based Navigation",[49],{"name":50,"affiliation":5,"role":51},"Brittney L. Keller-Hamilton, PhD, MPH","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":34,"email":57},"The Ohio State University Comprehensive Cancer Center","CONTACT","800-293-5066","OSUCCCClinicaltrials@osumc.edu",[59],{"facility":5,"status":34,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Columbus","Ohio","43210","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-82.99879,39.96118,{"lat":69,"lon":68},[72],{"name":50,"role":51,"phone":34,"phoneExt":34,"email":34},{"type":51,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Brittney Keller-Hamilton","Principal Investigator","100631687","phase-4-thrive-study-understanding-how-oral-nicotine-pouches-affect-public-health-100631687",false,"NCT07503925","THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health","THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health","THRIVE","Inclusion Criteria:\n\n* Age 21 or older\n* Able to read and speak English\n* Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits\n* Exclusive use of ONPs (other product use \\\u003C10x\u002Fmo).\n* Exhaled CO reading \\\u003C10 ppm\n* Owns a smartphone and can receive SMS text messages with embedded survey links\n* Negative pregnancy test at V1 and V2 (if applicable)\n* Uses ≥1.5 cans of ONPs\u002Fweek\n* Daily use of ONPs for the past 3 months\n* At least half of ONPs used are 6mg nicotine concentration.\n\nExclusion Criteria:\n\n* Non-English speaker\n* Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).\n* Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.\n* Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts\n* Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.",true,"ALL","21 Years",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.\n\nThis study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.",[95],"Tobacco-Related Carcinoma",[97,98,99,100],"Tobacco","Oral Nicotine Pouches","Particle Size","Tobacco Regulation","NOT_YET_RECRUITING","2026-05-21",{"date":104,"type":105},"2026-05-26","ACTUAL",{"date":107,"type":89},"2026-07-01",{"date":109,"type":89},"2027-12-31",{"name":5,"class":6},1]