[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501895":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":68,"collaborators":32,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":32,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":32,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":57,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"E-cigarettes (EC)","EXPERIMENTAL","Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.",[13,14,15],"Other: E-cigarette (EC)","Behavioral: Harm-Reduction Counseling","Behavioral: Ecological Momentary Intervention (EMI) Text Messaging",{"label":17,"type":18,"description":19,"interventionNames":20},"Nicotine Replacement Therapy (NRT)","ACTIVE_COMPARATOR","Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.",[21,14,15],"Other: Nicotine Replacement Therapy (NRT)",[23,29,33,38],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"E-cigarette (EC)","Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.",[9],[28],"NJOY Ace or NJOY Daily Electronic Cigarette",{"type":6,"name":17,"description":30,"armGroupLabels":31,"otherNames":32},"Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.",[17],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Harm-Reduction Counseling","At baseline, after randomization, participants will receive their first telehealth session (20\\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\\~20 minutes each.",[9,17],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Ecological Momentary Intervention (EMI) Text Messaging","EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.",[9,17],[43],{"name":44,"affiliation":5,"role":45},"Omar El-Shahawy","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":32,"email":50},"CONTACT","646-501-3587","Omar.ElShahawy@nyulangone.org",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},"Izamar Gallardo Castillo","646-501-3602","Izamar.gallardocastillo@nyulangone.org",[56],{"facility":5,"status":57,"city":58,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":32},"RECRUITING","New York","10016","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-74.00597,40.71427,{"lat":66,"lon":65},{"type":69,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100501895","e-cigarettes-for-harm-reduction-among-smokers-with-serious-mental-illness-100501895",false,"NCT05815199","E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness","Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness","Inclusion Criteria:\n\n* Currently smokes 5 or more CPD\n* Willingness and ability to provide informed consent\n* Age of at least 21 years\n* Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool\n* Interested in reducing CC smoking but not necessarily trying to quit\n* Own a mobile phone or have regular access to a mobile phone\n* Able to provide an additional contact to improve follow-up rates\n\nExclusion Criteria:\n\n* Is pregnant or breastfeeding\n* Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)\n* Currently engaged in an attempt to quit CC\n* Change in dose of their psychotropic medication(s) in the last 30 days\n* Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.\n* Past month suicidal ideation\u002Fsuicide attempt and\u002For psychiatric hospitalization in the last 30 days","ALL","21 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"NA","In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.",[87],"Cigarette Smoking",[89,90,91,92],"E-cigarettes","Harm reduction","Cigarette smoking","Serious mental illness","2025-10-08",{"date":95,"type":96},"2025-10-10","ACTUAL",{"date":98,"type":96},"2023-11-13",{"date":100,"type":81},"2026-03",{"name":5,"class":6},1]