Nctid:
NCT06232447
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12478", "name"=>"Nicotine", "relevance"=>"LOW"}, {"id"=>"M11591", "name"=>"Menthol", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"All participants will be asked to switch to smoking non-menthol cigarettes for four weeks."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>68}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-12", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Affect", "timeFrame"=>"4 weeks", "description"=>"Positive and Negative Affect Scale (PANAS)"}, {"measure"=>"Urge to smoke", "timeFrame"=>"4 weeks", "description"=>"Questionnaire on Smoking Urges-Brief (QSU)"}, {"measure"=>"Nicotine Dependence", "timeFrame"=>"4 weeks", "description"=>"Fagerström Test for Cigarette Dependence (FTCD)"}, {"measure"=>"Number of cigarettes smoked", "timeFrame"=>"4 weeks", "description"=>"Self-reported total number of menthol and non-menthol cigarettes smoked per day"}, {"measure"=>"CO level", "timeFrame"=>"4 weeks", "description"=>"in ppm"}], "primaryOutcomes"=>[{"measure"=>"high sensitivity C-reactive protein", "timeFrame"=>"4 weeks", "description"=>"from serum in mg/dL"}, {"measure"=>"Fibrinogen", "timeFrame"=>"4 weeks", "description"=>"from serum in mg/dL"}, {"measure"=>"Cytokine Panel 13", "timeFrame"=>"4 weeks", "description"=>"from serum in mg/dL"}], "secondaryOutcomes"=>[{"measure"=>"Blood pressure", "timeFrame"=>"4 weeks", "description"=>"systolic blood pressure and diastolic blood pressure, in mm Hg"}, {"measure"=>"Heart rate", "timeFrame"=>"4 weeks", "description"=>"beats per minute"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cigarette Smoking", "Inflammatory Response"]}, "descriptionModule"=>{"briefSummary"=>"This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.", "detailedDescription"=>"The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, smoking behavior, and subjective responses related to smoking. MC smokers (N=68) will be recruited for a five-week study, with one-week of baseline of MC smoking (Phase 1), followed by four weeks of switching to study-provided, brand-matched NMCs (Phase 2). Biomarkers of systemic inflammation and tobacco exposure will be analyzed from blood samples before, during, and after switching for four weeks (baseline, week 1, week 3, and week 5). Ecological momentary assessment methods will also be gathered to measure patterns of smoking and smoking-related subjective responses (affect, craving)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion criteria\n\n* Men and women between 21-85 years old\n* Currently uses menthol cigarettes\n* Daily smoking rate of ≥5 cigarettes/day for ≥1 year\n* Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application\n* Able to read and communicate fluently in English\n\nExclusion criteria\n\n* Currently pregnant or breastfeeding\n* Actively trying to quit smoking\n* Current heavy alcohol use\n* Frequent use of non-menthol cigarettes, other smoking products, marijuana, or illicit substances\n* History of severe medical/psychiatric condition or treatment"}, "identificationModule"=>{"nctId"=>"NCT06232447", "acronym"=>"MINT", "briefTitle"=>"Menthol, Inflammation, and Nicotine Transition Study", "organization"=>{"class"=>"OTHER", "fullName"=>"Rosalind Franklin University of Medicine and Science"}, "officialTitle"=>"Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban", "orgStudyIdInfo"=>{"id"=>"CHP22-366"}, "secondaryIdInfos"=>[{"id"=>"K01HL164670", "link"=>"https://reporter.nih.gov/quickSearch/K01HL164670", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Cigarette Type Switching", "description"=>"Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes", "interventionNames"=>["Other: Cigarette Type Switching"]}], "interventions"=>[{"name"=>"Cigarette Type Switching", "type"=>"OTHER", "description"=>"Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of four weeks", "armGroupLabels"=>["Cigarette Type Switching"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60064", "city"=>"North Chicago", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Nancy C Jao, PhD", "role"=>"CONTACT", "email"=>"nancy.jao@rosalindfranklin.edu", "phone"=>"847-578-8747"}], "facility"=>"Rosalind Franklin University of Medicine and Science", "geoPoint"=>{"lat"=>42.32558, "lon"=>-87.84118}}], "centralContacts"=>[{"name"=>"Nancy C Jao, PhD", "role"=>"CONTACT", "email"=>"nancy.jao@rosalindfranklin.edu", "phone"=>"847-578-8747"}], "overallOfficials"=>[{"name"=>"Nancy C Jao, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Rosalind Franklin University of Medicine and Science"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Rosalind Franklin University of Medicine and Science", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Nancy Jao", "investigatorAffiliation"=>"Rosalind Franklin University of Medicine and Science"}}}}
