Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT05538702
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Oral Effects of Heated Tobacco Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in blood flow after smoking', 'timeFrame': 'baseline, immediately after smoking, and 15 minutes after smoking', 'description': 'The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline), immediately after, and 15 minutes after smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nicotine', 'heated tobacco product', 'blood flow', 'cigarette'], 'conditions': ['Nicotine Dependence, Cigarettes']}, 'descriptionModule': {'briefSummary': 'Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives to smoking. Use and awareness of these devices have grown exponentially in recent years, with probably millions of people currently using them. There is very little literature about them, so it is quite important to study the effects caused on the human body by these products.\n\nThe benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.', 'detailedDescription': 'Measurements of acute oral effects before and after using HTP with bland flavour (HEETS Bronze Selection), with methol flavour (HEETS Blue Selection), conventional cigarette and placebo device:\n\nmeasurement of exhaled CO changes by Smokerlyzer piCO measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method) measurement of blood pressure and pulse by an automatic blood pressure monitor (Omron M2, Omron Healthcare Inc., Kyoto, Japan)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-49 years\n* signed consent form\n* smoking regularly heated tobacco product and/or conventional cigarette for \\> half year\n\nExclusion Criteria:\n\n* not pregnant and not planning pregnancy in the next 6 month BMI index \\< 30\n* no severe parodontal disease\n* no acute illness in the last 2 weeks\n* no chronic disease (eg.: diabetes)'}, 'identificationModule': {'nctId': 'NCT05538702', 'briefTitle': 'Acute Oral Effects of Heated Tobacco Products', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Acute Oral Effects of Heated Tobacco Products Compared to Traditional Cigarettes', 'orgStudyIdInfo': {'id': '91-3/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heated tobacco product with bland taste unit', 'description': 'Nicotine content: 0,5 mg', 'interventionNames': ['Device: IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)']}, {'type': 'EXPERIMENTAL', 'label': 'Heated tobacco product with menthol taste unit', 'description': 'Nicotine content: 0,5 mg', 'interventionNames': ['Device: IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional cigarette', 'description': 'Nicotine content: 0,5 mg', 'interventionNames': ['Device: Marlboro Gold (Conventional cigarette)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Heated tobacco product turned off with a bland taste unit', 'description': 'Placebo device', 'interventionNames': ['Device: IQOS 3.0 DUO turned off with a bland taste unit']}], 'interventions': [{'name': 'IQOS 3.0 DOU with bland taste unit (Heated Tobacco Product)', 'type': 'DEVICE', 'otherNames': ['IQOS 3.0 DUO', 'HEETS Bronze Selection'], 'description': 'Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.', 'armGroupLabels': ['Heated tobacco product with bland taste unit']}, {'name': 'IQOS 3.0 DUO with menthol taste unit (Heated Tobacco Product)', 'type': 'DEVICE', 'otherNames': ['IQOS 3.0 DUO', 'HEETS Blue Selection'], 'description': 'Heated tobacco products (HTP) are devices which heat but do not burn tobacco. They do not produce cigarette smoke but rather an aerosol.', 'armGroupLabels': ['Heated tobacco product with menthol taste unit']}, {'name': 'Marlboro Gold (Conventional cigarette)', 'type': 'DEVICE', 'otherNames': ['Marlboro Gold 0,5 mg'], 'description': 'Conventional cigarette', 'armGroupLabels': ['Conventional cigarette']}, {'name': 'IQOS 3.0 DUO turned off with a bland taste unit', 'type': 'DEVICE', 'otherNames': ['IQOS 3.0 DUO', 'HEETS Bronze Selection'], 'description': 'Placebo device', 'armGroupLabels': ['Heated tobacco product turned off with a bland taste unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University, Department of Prosthodontics', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}