[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490387":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":35,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":35,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":35,"overallStatus":48,"whyStopped":35,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will be administered 2 nasal sprays with a combined nicotine content of 0mg nicotine, 0.1mL",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"0.5mg nicotine","EXPERIMENTAL","Participants will be administered 2 nasal sprays with a combined nicotine content of 0.5 mg nicotine, 0.1mL",[19,13],"Drug: Nicotine nasal spray 0.5 mg",{"label":21,"type":16,"description":22,"interventionNames":23},"1mg nicotine","Participants will be administered 2 nasal sprays with a combined nicotine content of 1.0 mg nicotine, 0.1mL",[19],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Nicotine nasal spray 0.5 mg","Participants will be administered nicotine nasal spray and provide subjective reactions",[15,21],[31],"Nicotrol",{"type":26,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"Participants will be administered placebo nasal spray and provide subjective reactions",[15,9],null,[37],{"name":38,"affiliation":5,"role":39},"Maggie Sweitzer, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":35,"email":44},"CONTACT","919-668-0094","maggie.sweitzer@duke.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.89862,35.99403,{"lat":58,"lon":57},[61],{"name":38,"role":42,"phone":43,"phoneExt":35,"email":44},{"type":63,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[65],{"name":66,"class":67},"National Institute on Drug Abuse (NIDA)","NIH","100490387","early-phase-1-neurobehavioral-mechanisms-linking-childhood-adversity-to-increased-risk-for-smoking-100490387",false,"NCT05665465","Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking","Inclusion Criteria:\n\n1. generally healthy\n2. 18-21 years of age\n3. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products\n4. no tobacco exposure in the past 3 years\n5. expired air CO level ≤ 3 ppm\n6. corroboration of non-smoking status from 2 collateral reporters\n7. breath alcohol value = 0.000\n\nExclusion Criteria:\n\n1. use of illegal drugs as measured by urine drug screen\n2. reported history of illicit drug use \\> 10 times lifetime\n3. lifetime history of alcohol use disorder\n4. binge drinking \\> 5 times per month over the past 3 months\n5. history of serious mental illness including bipolar or psychotic disorders\n6. significant medical or unstable psychiatric disorders\n7. systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\n8. heart rate ≥ 100 bpm\n9. use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months\n10. presence of conditions that would make fMRI unsafe (e.g., pacemaker)\n11. brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)\n12. history of serious traumatic brain injury\n13. claustrophobia\n14. lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year\n15. pregnant, trying to become pregnant, or breastfeeding\n16. inability to understand written and\u002For spoken English language\n17. inability to attend all experimental sessions",true,"ALL","18 Years","21 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"EARLY_PHASE1","The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and\u002For a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.",[86,87],"Adverse Childhood Experiences","Nicotine Dependence, Cigarettes","2026-04-01",{"date":90,"type":91},"2026-04-02","ACTUAL",{"date":93,"type":91},"2024-01-19",{"date":95,"type":80},"2027-05-31",{"name":5,"class":6},1]