Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-02 @ 5:45 AM
Study NCT ID:
NCT06816459
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are blinded to brand and condition'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menthol smell presence', 'timeFrame': 'Up to 1 year', 'description': 'Will evaluate ratings of menthol smell presence (0-5 scale). Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.'}, {'measure': 'Mint-like smell', 'timeFrame': 'Up to 1 year', 'description': 'Will evaluate ratings of mint-like smell (0-4 scale). Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.'}, {'measure': 'Cooling sensation during taste test', 'timeFrame': 'Up to 1 year', 'description': 'Will be assessed using a self-rated coolness measure on a 0-100 visual analog scale. Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.'}], 'secondaryOutcomes': [{'measure': 'California (CA) version of the test brand cigarette', 'timeFrame': 'Up to 1 year', 'description': 'Will evaluate proportion correctly identifying the CA version of the test brand cigarette.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking-Related Carcinoma']}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well current daily smoking adults can identify flavors of cigarettes. Menthol cigarettes account for 31 percent of cigarettes sold in the United States. Flavors such as menthol play an important role in the start and continued use of tobacco products. Two ways users experience flavor is through smell and taste. Menthol has cooling and numbing properties that can increase perceptions of smoothness and reduce the perceived harshness of smoke. Menthol adds a taste and aroma commonly described as "minty". The effect of menthol flavoring on smoking behavior has been studied. Use of menthol cigarettes has been associated with greater nicotine dependence and is associated with both fewer quit attempts and lower odds of quit success. In 2022, the Food and Drug Administration proposed to restrict the use of menthol as a flavor in cigarettes. Menthol has already been banned in Canada, the United Kingdom and the European Union. In late 2022, a restriction on all flavored tobacco products went into effect in California (CA), prompting the tobacco industry to introduce substitute products that did not contain menthol. It is important to find out whether New York (NY) adult smokers who smoke menthol cigarettes can identify and characterize flavors in the same cigarette brand as sold in NY versus CA following the ban of menthol cigarettes in 2022.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To convene a consumer panel of adult smokers in New York state (N=24) to assess the smelling properties of a sample of cigarette products sold in the New York and California markets to identify any characterizing flavors.\n\nEXPLORATORY OBJECTIVE:\n\nI. To collate consumer-test findings, highlighting quantitative analysis of any characterizing flavors identified, as well as any qualitative insights from the panel about specific products.\n\nOUTLINE: Participants are randomized to 1 of 2 blocks.\n\nBLOCK ALPHA: Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the Brief Smell Identification Test (B-SIT) during session 1, a block alpha cigarette smell test with a total of 16 cigarette products during session 2 and a block alpha cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.\n\nBLOCK BETA: Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block beta cigarette smell test with a total of 16 cigarette products during session 2 and a block beta cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21-55 years old\n* Current daily smoker of factory-made menthol cigarettes\n* General good health (assessed by self-rated health item)\n* Completion of Brief Smell Identification Test (B-SIT) with no identification of deficits\n\nExclusion Criteria:\n\n* Daily concurrent use of other tobacco products (e.g., e-cigarettes, cigars, smokeless tobacco)\n* Known allergies to mint (peppermint, spearmint), menthol\n* Self-reported olfactory or taste deficits\n* Pregnant or nursing participants, as indicated by self-report\n* History of medications known to interfere with sense of smell\n* Positive diagnosis of coronavirus 2019 (COVID-19) within 10 days of enrollment\n* Current upper respiratory infection or sinus congestion (e.g., cold, flu, seasonal allergies) (by self report)'}, 'identificationModule': {'nctId': 'NCT06816459', 'briefTitle': 'Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Sensory Evaluation of Cigarettes Claiming Removal of Menthol as a Characterizing Flavor', 'orgStudyIdInfo': {'id': 'I-3571524'}, 'secondaryIdInfos': [{'id': 'NCI-2025-00202', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I-3571524', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Block Alpha (block alpha cigarette tests)', 'description': 'Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block alpha cigarette smell test with a total of 16 cigarette products during session 2 and a block alpha cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.', 'interventionNames': ['Other: Cigarette smell test', 'Other: Cigarette Taste Test', 'Other: Study questionnaires']}, {'type': 'EXPERIMENTAL', 'label': 'Block Beta (block beta cigarette tests)', 'description': 'Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block beta cigarette smell test with a total of 16 cigarette products during session 2 and a block beta cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.', 'interventionNames': ['Other: Cigarette smell test', 'Other: Cigarette Taste Test', 'Other: Study questionnaires']}], 'interventions': [{'name': 'Cigarette smell test', 'type': 'OTHER', 'description': 'Undergo cigarette smell test of 16 cigarettes in vials, then rate the overall smell on a 5 pt scale (not at all, a little noticeable, noticeable, clearly/very noticeable , do not know what this is).', 'armGroupLabels': ['Block Alpha (block alpha cigarette tests)', 'Block Beta (block beta cigarette tests)']}, {'name': 'Cigarette Taste Test', 'type': 'OTHER', 'otherNames': ['Taste Test'], 'description': 'Participants will be present 3 vials , each containing a cigarette and sample in order specified on label, then complete a coolness measure on a 0-100 visual analog scale.', 'armGroupLabels': ['Block Alpha (block alpha cigarette tests)', 'Block Beta (block beta cigarette tests)']}, {'name': 'Study questionnaires', 'type': 'OTHER', 'description': 'Sensory questionnaires will be administered using a web based application', 'armGroupLabels': ['Block Alpha (block alpha cigarette tests)', 'Block Beta (block beta cigarette tests)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Richard J. O'Connor", 'role': 'CONTACT', 'email': 'Richard.OConnor@RoswellPark.org', 'phone': '716-845-4517'}, {'name': "Richard J. O'Connor", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': "Richard J O'Connor", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}