[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06310187":3,"trial-entities:NCT06310187":124,"trial-summary:NCT06310187":127},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":83,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":15,"eligibility_criteria":87,"std_ages":91,"locations":94,"central_contacts":113,"overall_officials":119,"references":122,"see_also_links":123},"NCT06310187","STUDY000023967","Little Cigar Oxidants","Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars","RECRUITING","2029-08","2026-06","2026-06-16","2026-03-25","Milton S. Hershey Medical Center","OTHER",false,"Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.","Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein.\n\nExhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles.\n\nBlood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress.\n\nBuccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts.\n\nSalvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.",[19,20],"Tobacco Use","Oxidative Stress",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30,37,41],{"type":14,"name":31,"description":32,"armGroupLabels":33},"High Oxidant Little Cigar","Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.",[34,35,36],"Group A","Group B","Group C",{"type":14,"name":38,"description":39,"armGroupLabels":40},"Low Oxidant Little Cigar","Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.",[34,35,36],{"type":14,"name":42,"description":43,"armGroupLabels":44},"Usual Cigarette","Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.",[34,35,36],[46,49,51,53,55,56,57,59,60,61,63,64,65,67,68,70,71,73,74,76,77,79,80,82],{"measure":47,"timeFrame":48},"8-isoprostanes Concentration in Exhaled Breath Condensate","-5 minutes",{"measure":50,"timeFrame":48},"8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate",{"measure":52,"timeFrame":48},"C-reactive Protein Concentration in Exhaled Breath Condensate",{"measure":47,"timeFrame":54},"0 minutes",{"measure":50,"timeFrame":54},{"measure":52,"timeFrame":54},{"measure":47,"timeFrame":58},"30 minutes",{"measure":50,"timeFrame":58},{"measure":52,"timeFrame":58},{"measure":47,"timeFrame":62},"60 minutes",{"measure":50,"timeFrame":62},{"measure":52,"timeFrame":62},{"measure":66,"timeFrame":48},"Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples",{"measure":66,"timeFrame":54},{"measure":69,"timeFrame":48},"Nicotine concentration in Blood Samples",{"measure":69,"timeFrame":54},{"measure":72,"timeFrame":48},"8-isoprostanes Concentration in Blood Samples",{"measure":72,"timeFrame":54},{"measure":75,"timeFrame":48},"8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples",{"measure":75,"timeFrame":54},{"measure":78,"timeFrame":48},"8-OHdg Acrolein Adduct Concentration in Saliva Samples",{"measure":78,"timeFrame":54},{"measure":81,"timeFrame":48},"Metabolomic Profiles in Saliva Samples",{"measure":81,"timeFrame":54},[],"ALL","21 Years","65 Years",{"inclusion":88,"exclusion":89,"raw_text":90},[],[],"Inclusion Criteria:\n\n1. Aged 21 - 65 years old\n2. Daily cigarette smoker (\\>= 1 cigarette per day);\n3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter\n4. No current or past use of Little Cigars\n5. All other forms of nicotine must be used \\\u003C6 days out of the past 30 days.\n6. Able to read and write in English\n7. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days\n8. No plan to quitting smoking in the next 3 months\n\nExclusion Criteria:\n\n1. Women who are pregnant and\u002For nursing or trying to become pregnant\n2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)\n3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV\u002FAIDS, multiple sclerosis symptoms) or any medical disorder\u002Fmedication that may affect participant safety or biomarker data\n4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months\n5. Exhaled Carbon Monoxide (CO) measurement of \\>= 17 parts per million",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":110},"Penn State College of Medicine","Hershey","Pennsylvania","17033","United States",[102,107],{"name":103,"role":104,"phone":105,"email":106},"Kenneth Houser, MS","CONTACT","7175315473","khouser@pennstatehealth.psu.edu",{"name":108,"role":109},"Joshua Muscat, PhD","PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},40.28592,-76.65025,[114,118],{"name":115,"role":104,"phone":116,"email":117},"Joshua Muscat, Ph.D.","7175318521","jmuscat@pennstatehealth.psu.edu",{"name":103,"role":104,"phone":105,"email":106},[120],{"name":115,"affiliation":121,"role":109},"Penn State Hershey College of Medicine",[],[],{"nct_id":4,"conditions":125,"biomarkers":126},[19],[],{"nct_id":4,"found":128,"summary":129,"prompt_version":139},true,{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study with 50 participants. It uses a balanced randomized cross-over design, meaning you would try each of the three products in a random order.","completed","Little Cigar Oxidants Study","This study aims to understand how little cigars affect your body's exposure to harmful substances called oxidants (molecules that can damage cells). If you are a daily cigarette smoker, aged 21-65, and do not currently use little cigars, you might be able to join. In this study, you would use a High Oxidant Little Cigar, a Low Oxidant Little Cigar, and your usual cigarette in a lab setting. Researchers will collect biological samples, like breath and blood, before and after you use these products. The main goal is to measure specific oxidant markers, such as 8-isoprostanes, 8-OHdg Acrolein Adducts, and C-reactive Protein, in your exhaled breath condensate to see how different products impact these levels.","Not specified.",115,"You would visit the lab to use a High Oxidant Little Cigar, a Low Oxidant Little Cigar, and your usual cigarette. Biological samples (breath, blood, buccal cells, saliva) will be collected before and after product use, and at 30 and 60 minutes for some breath samples.","Not stated in the trial record.",[31,38,42],"v2"]