[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519424":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":60,"centralContacts":65,"locations":74,"responsibleParty":106,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":43,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":43,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":43,"overallStatus":76,"whyStopped":43,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",[8,15,20,25,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"0 mg + Smooth flavor","EXPERIMENTAL","Participants are provided with zero strength (0 mg) nicotine pouches with smooth flavor.",[13,14],"Other: 0 mg nicotine pouch","Other: Smooth nicotine pouch",{"label":16,"type":10,"description":17,"interventionNames":18},"3 mg + Smooth flavor","Participants are provided with medium strength (3 mg) nicotine pouches with smooth flavor.",[19,14],"Other: 3 mg nicotine pouch",{"label":21,"type":10,"description":22,"interventionNames":23},"6 mg + Smooth flavor","Participants are provided with high strength (6 mg) nicotine pouches with smooth flavor.",[24,14],"Other: 6 mg nicotine pouch",{"label":26,"type":10,"description":27,"interventionNames":28},"0 mg + Wintergreen flavor","Participants are provided with zero strength (0 mg) nicotine pouches with wintergreen flavor.",[13,29],"Other: Wintergreen nicotine pouch",{"label":31,"type":10,"description":32,"interventionNames":33},"3 mg + Wintergreen flavor","Participants are provided with medium strength (3 mg) nicotine pouches with wintergreen flavor.",[19,29],{"label":35,"type":10,"description":36,"interventionNames":37},"6 mg + Wintergreen flavor","Participants are provided with high strength (6 mg) nicotine pouches with wintergreen flavor.",[24,29],[39,44,48,52,56],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"0 mg nicotine pouch","Oral nicotine pouches that contain 0 mg of nicotine",[9,26],null,{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"3 mg nicotine pouch","Oral nicotine pouches that contain 3 mg of nicotine",[16,31],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"6 mg nicotine pouch","Oral nicotine pouches that contain 6 mg of nicotine",[21,35],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":43},"Smooth nicotine pouch","Non-flavored nicotine pouches that are characterized as smooth.",[9,16,21],{"type":6,"name":57,"description":58,"armGroupLabels":59,"otherNames":43},"Wintergreen nicotine pouch","Menthol flavored nicotine pouches that are characterized as wintergreen.",[26,31,35],[61],{"name":62,"affiliation":63,"role":64},"Jonathan Foulds, PhD","Penn State College of Medicine","PRINCIPAL_INVESTIGATOR",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":43,"email":70},"Nicolle M Krebs, MS","CONTACT","717-531-5673","nkrebs@pennstatehealth.psu.edu",{"name":62,"role":68,"phone":72,"phoneExt":43,"email":73},"717-531-3504","jfoulds@pennstatehealth.psu.edu",[75,91],{"facility":63,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","Hershey","Pennsylvania","17033","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-76.65025,40.28592,{"lat":86,"lon":85},[89,90],{"name":67,"role":68,"phone":69,"phoneExt":43,"email":70},{"name":62,"role":64,"phone":43,"phoneExt":43,"email":43},{"facility":92,"status":76,"city":93,"state":94,"zip":95,"country":80,"countryCode":81,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":83,"coordinates":97},[98,99],-95.36327,29.76328,{"lat":99,"lon":98},[102],{"name":103,"role":68,"phone":104,"phoneExt":43,"email":105},"Jason Robinson, PhD","713-745-3581","jdrobinson@mdanderson.org",{"type":64,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Jonathan Foulds","Professor",[110],{"name":111,"class":112},"National Institute on Drug Abuse (NIDA)","NIH","100519424","use-of-nicotine-pouches-among-daily-smokers-100519424",false,"NCT06043362","Use of Nicotine Pouches Among Daily Smokers","Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers","Inclusion Criteria:\n\n* Commonly smoke ≥ 5 cigarettes per day (at least 2 days\u002Fweek) for at least the prior 12 months\n* Exhaled CO measurement of ≥ 6 parts per million at baseline\n* Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches\n* Able to understand, read and write in English\n* Access to e-mail and a smartphone\u002Fcomputer that has reliable internet connection\n* Able to understand and give informed consent\n\nExclusion Criteria:\n\n* Plans to quit smoking within the next 30 days\n* Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months\n* Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year)\n* Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease \\[COPD\\], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder\u002Fmedication that may affect participant safety or biomarker data\n* Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days\n* Use of illegal drugs daily or weekly in the past 3 months\n* Use of combustible (smoked) recreational or medical marijuana weekly in the past 3 months (less frequent smoked medical marijuana or use of other forms of medical marijuana are ok)\n* Other member of the household currently participating in the study\n* Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol",true,"ALL","21 Years","70 Years",{"count":125,"type":126},375,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims are:\n\n1. Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicators of potential harms to health.\n2. Examine the influence of nicotine pouch use on conventional tobacco product use (cigarettes).\n\nParticipants will be randomized to one of six nicotine pouch groups (3 nicotine strengths, each with 2 potential flavors) to use over 16 weeks and asked to reduce their cigarette smoking over that time by at least 75% by substituting with the use of the nicotine pouches. Researchers will compare the outcomes of the different nicotine pouch strengths and flavors to each other. Participants will be asked to complete study questionnaires and provide urine, exhaled carbon monoxide, and mouth cell samples, and other health measurements.",[132],"Tobacco Dependence","2025-09-26",{"date":135,"type":136},"2025-10-01","ACTUAL",{"date":138,"type":136},"2024-09-17",{"date":140,"type":126},"2028-08",{"name":5,"class":6},2]