Nctid:
NCT06617520
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Subjective response to smoking", "timeFrame"=>"Laboratory visits, up to 3 weeks after the baseline", "description"=>"average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7"}, {"measure"=>"Number of cigarillos smoked", "timeFrame"=>"Daily smartphone surveys, up to 3 weeks after the baseline", "description"=>"The number of cigarillos smoked during each 7-day take-home period"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Tobacco Use"]}, "descriptionModule"=>{"briefSummary"=>"This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)", "detailedDescription"=>"Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (\\>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of \"take home\" use, abstinent participants (\\>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"34 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Ages18 to 34\n* Smoke little cigars/cigarillos (LCCs) \"some days\" or \"everyday\"\n* Ability to read English at an 8th grade level or higher\n* No immediate plans to quit using tobacco\n\nExclusion Criteria:\n\n* Current use of nicotine replacement therapy (NRT)\n* Pregnant, planning to become pregnant, or currently breastfeeding\n* Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion Inability to abstain from nicotine/tobacco products for at least 12 hours prior to each of two study sessions\n* Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)\n* Unwillingness to use \"untipped\" (e.g., plastic or wood tip) little cigars/cigarillos."}, "identificationModule"=>{"nctId"=>"NCT06617520", "acronym"=>"ASPIRE", "briefTitle"=>"Attitudes and Smoking Perceptions in the Real Environment", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Oklahoma"}, "officialTitle"=>"Attitudes and Smoking Perceptions in the Real Environment", "orgStudyIdInfo"=>{"id"=>"ASPIRE"}, "secondaryIdInfos"=>[{"id"=>"ST116745", "type"=>"OTHER_GRANT", "domain"=>"Presbyterian Health Foundation"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Tobacco flavor cigarillo", "description"=>"A participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory", "interventionNames"=>["Other: Cigarillo flavor type"]}, {"type"=>"EXPERIMENTAL", "label"=>"Concept flavor cigarillo", "description"=>"A participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory", "interventionNames"=>["Other: Cigarillo flavor type"]}, {"type"=>"EXPERIMENTAL", "label"=>"Characterizing flavor", "description"=>"A participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory", "interventionNames"=>["Other: Cigarillo flavor type"]}], "interventions"=>[{"name"=>"Cigarillo flavor type", "type"=>"OTHER", "description"=>"Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor", "armGroupLabels"=>["Characterizing flavor", "Concept flavor cigarillo", "Tobacco flavor cigarillo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"73104", "city"=>"Oklahoma City", "state"=>"Oklahoma", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael Smith", "role"=>"CONTACT", "email"=>"Enhance@ouhsc.edu", "phone"=>"405-271-7759"}, {"name"=>"Amy Cohn, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"TSET Health Promotion Research Center", "geoPoint"=>{"lat"=>35.46756, "lon"=>-97.51643}}], "centralContacts"=>[{"name"=>"HEAL Lab Project Manager", "role"=>"CONTACT", "email"=>"Enhance@ouhsc.edu", "phone"=>"405-271-7759"}, {"name"=>"Michael Smith, MPH", "role"=>"CONTACT"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Sharing may be available at the discretion and with the permission of the university and an approved data use agreement."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Oklahoma", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Presbyterian Health Foundation", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
