[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487538":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":13,"armGroups":28,"interventions":47,"overallOfficials":70,"centralContacts":74,"locations":82,"responsibleParty":102,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":13,"enrollmentInfo":117,"targetDuration":13,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":13,"overallStatus":85,"whyStopped":13,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"7-day smoking abstinence","Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment","6 Months",null,[15],{"measure":16,"description":17,"timeFrame":18},"Self-reported abstinence","Continuous abstinence, quit attempts, smoking reduction","1, 3, 6 months",{"allocation":20,"interventionModel":21,"interventionModelDescription":13,"primaryPurpose":22,"observationalModel":13,"timePerspective":13,"maskingInfo":23},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":24,"maskingDescription":13,"whoMasked":25},"SINGLE",[26],"PARTICIPANT","The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.",[29,36,42],{"label":30,"type":6,"description":31,"interventionNames":32},"Ask-Advice-Assist (AAA)","All patients will be screened for tobacco use, and offer brief cessation advice and counseling.",[33,34,35],"Behavioral: Educational materials","Behavioral: Provider training","Behavioral: Electronic reminders",{"label":37,"type":38,"description":39,"interventionNames":40},"Ask-Advise-Connect (AAC)","EXPERIMENTAL","Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.",[33,41,34,35],"Behavioral: Phone counseling",{"label":43,"type":38,"description":44,"interventionNames":45},"Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)","In addition to AAC, patients will be offered NRT.",[33,41,46,34,35],"Drug: Nicotine Replacement Therapy",[48,53,57,62,66],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":13},"BEHAVIORAL","Educational materials","Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.",[30,37,43],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":13},"Phone counseling","Cessation counseling to address insufficient patient self-efficacy and motivation.",[37,43],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":13},"DRUG","Nicotine Replacement Therapy","Nicotine patches to address nicotine withdrawal symptoms in patients.",[43],{"type":49,"name":63,"description":64,"armGroupLabels":65,"otherNames":13},"Provider training","Provider training to address insufficient knowledge and self-efficacy to deliver AAA\u002FAAC to patients.",[30,37,43],{"type":49,"name":67,"description":68,"armGroupLabels":69,"otherNames":13},"Electronic reminders","Electronic reminders to address the lack of integration of AAA\u002FAAC into practice.",[30,37,43],[71],{"name":72,"affiliation":5,"role":73},"Ramzi Salloum, PhD","PRINCIPAL_INVESTIGATOR",[75,79],{"name":72,"role":76,"phone":77,"phoneExt":13,"email":78},"CONTACT","(352) 294-4997","rsalloum@ufl.edu",{"name":80,"role":76,"phone":77,"phoneExt":13,"email":81},"Magda Montague, MPH","mschmitzberger@ufl.edu",[83],{"facility":84,"status":85,"city":86,"state":13,"zip":13,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"American University of Beirut Medical Center","RECRUITING","Beirut","Lebanon","LB",{"type":90,"coordinates":91},"Point",[92,93],35.50157,33.89332,{"lat":93,"lon":92},[96,101],{"name":97,"role":76,"phone":98,"phoneExt":99,"email":100},"Maya Romani, MD","+9611350000","3014","mr39@aub.edu.lb",{"name":97,"role":73,"phone":13,"phoneExt":13,"email":13},{"type":103,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[105],{"name":106,"class":107},"National Cancer Institute (NCI)","NIH","100487538","phone-enabled-implementation-of-cessation-support-100487538",false,"NCT05628389","Phone Enabled Implementation of Cessation Support","PHOENICS","Inclusion Criteria:\n\n* Age 18+\n* A current daily cigarette smoker and\u002For a regular waterpipe smoker (smokes at least 1-2 times\u002Fweek).\n* Not pregnant\n* Reachable by phone\n* Interested in quitting\n* Lives in Greater Beirut Area\n\nExclusion Criteria:\n\n* Patients who use other tobacco products including vape exclusively.\n* Any patient below 18 years old.\n* Cigarette smokers who do not smoke on daily basis.\n* Waterpipe smokers who smoke less than once\u002Fweekly","ALL","18 Years",{"count":118,"type":119},1500,"ESTIMATED","INTERVENTIONAL",[122],"NA","The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.",[125],"Smoking Cessation","2026-06-10",{"date":128,"type":129},"2026-06-12","ACTUAL",{"date":131,"type":129},"2024-03-06",{"date":133,"type":119},"2027-08-31",{"name":5,"class":6},1]