Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 10:41 PM
Study NCT ID:
NCT05468333
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in perceived chemical content relative to conventional condition - natural', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Survey measure'}, {'measure': 'Difference in perceived chemical content relative to conventional condition - organic', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Survey measure'}, {'measure': 'Difference in perceived chemical aftertaste to conventional condition - natural', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Survey measure'}, {'measure': 'Difference in perceived chemical aftertaste to conventional condition - organic', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Survey measure'}, {'measure': 'Difference in total puff volume relative to conventional condition - natural', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Total puff volume as measured by topography device'}, {'measure': 'Difference in total puff volume relative to conventional condition - organic', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'Total puff volume as measured by topography device'}, {'measure': 'Difference in salivary aldehyde concentration relative to conventional condition - natural', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'salivary aldehyde concentration measured in saliva'}, {'measure': 'Difference in salivary aldehyde concentration relative to conventional condition - organic', 'timeFrame': 'no sooner than 1 day after prior study visit and up to 3 months after first study visit.', 'description': 'salivary aldehyde concentration measured in saliva'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Behaviors']}, 'descriptionModule': {'briefSummary': 'Smokers believe that cigarettes with the "natural" or "organic" descriptors are less harmful than cigarettes without these descriptors, but we do not know if these beliefs are associated with how smokers interpret the experience of smoking a "natural" or "organic" cigarette, nor whether these beliefs are predictive of changes in smoking behavior or biological exposures. The primary goal of this study is to examine the relationship between exposure to "natural" or "organic" descriptors in cigarette advertising and smoking health risk expectancies, subjective effects, topography, and biological exposures. To accomplish this goal, we will enroll 250 adult daily cigarette smokers of Natural American Spirit (NAS) or non-NAS brands (125 in each group) in a within-subjects human laboratory study manipulating four expectancy conditions (own brand comparator, "natural" advertising, "organic" advertising, "conventional" advertising).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Self-identification as a man or woman', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Daily cigarette smoker of 5+ cigarettes/day for at least the past 6 months and consumed 100+ lifetime cigarettes\n* Smoke non-menthol, filtered cigarettes\n* Report daily use of any non-Natural American Spirit (NAS) cigarette brand for the last 30 days (for the non-NAS smoker group), or report daily use of NAS cigarettes for at least 30 days (for the NAS smoker group)\n* Provide exhaled CO level \\>= 10 ppm at the Session 1 visit\n* Able to communicate fluently in English (speaking, writing, and reading)\n* Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in human participant protections\n\nExclusion Criteria:\n\n* Current use of Nat's cigarettes as a preferred brand\n* Plan to quit smoking in the next 30 days and not currently undergoing smoking cessation treatment\n* Are pregnant, planning a pregnancy, and/or lactating\n* Have any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol\n* Have had a serious or unstable disease within the past 6 months (e.g. heart disease, cancer, schizophrenia).\n* Cannot have ever regularly smoked NAS (for the non-NAS group)"}, 'identificationModule': {'nctId': 'NCT05468333', 'briefTitle': '"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Reno'}, 'officialTitle': '"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers', 'orgStudyIdInfo': {'id': '5R01DA053619', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA053619', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main arm', 'description': 'Per NIH Program Official, this is not an ACT and thus full protocol info is not required at this time.', 'interventionNames': ['Other: Cigarette trial']}], 'interventions': [{'name': 'Cigarette trial', 'type': 'OTHER', 'description': 'Per NIH Program Official, this is not an ACT and thus full protocol info is not required at this time (and would be detrimental to the study if details were disclosed during recruitment).', 'armGroupLabels': ['Main arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89512', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Desert Research Institute', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '89557', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada, Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Reno', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Pearson', 'investigatorAffiliation': 'University of Nevada, Reno'}}}}