[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606097":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":31,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuation of standard varenicline dosing (1mg BID)","ACTIVE_COMPARATOR","1\\. A group that continues to take varenicline 1mg twice a day (no change)",[13],"Drug: Standard Varenicline Dosing (1 mg BID)",{"label":15,"type":16,"description":17,"interventionNames":18},"Combination Therapy of varenicline 1mg BID with the addition of bupropion 150 mg BID","EXPERIMENTAL","A group assigned to the combination of standard varenicline dosing (1 mg PO BID) with bupropion (150 mg PO BID)",[13,19],"Drug: Bupropion 150 mg twice daily",{"label":21,"type":16,"description":22,"interventionNames":23},"Increased Varenicline Dosing (1 mg TID)","A group assigned to increased varenicline (1mg oral three times a day) dosing",[24],"Drug: Increased Varenicline Dosing (1mg TID)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Standard Varenicline Dosing (1 mg BID)","Varenicline PO (oral) 1mg twice daily",[15,9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Bupropion 150 mg twice daily","Bupropion 150 mg PO twice daily",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Increased Varenicline Dosing (1mg TID)","Varenicline 1mg PO (oral) three times daily",[21],[41],{"name":42,"affiliation":5,"role":43},"Samuel Han, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Shelly Ward","CONTACT","507-538-9997","Ward.Shelly1@mayo.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Rochester","Minnesota","55902","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-92.4699,44.02163,{"lat":62,"lon":61},[65],{"name":46,"role":47,"phone":66,"phoneExt":31,"email":67},"507-293-5574","ward.shelly1@mayo.edu",{"type":43,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Samuel Han","Principal Investigator","100606097","phase-2-smoking-cessation-trial-in-recurrent-acute-pancreatitis-and-chronic-pancreatitis-100606097",false,"NCT07171112","Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis","Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis","Inclusion Criteria\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 or older\n* Diagnosed with either recurrent acute pancreatitis or chronic pancreatitis as defined by the American Pancreatic Association:\n\n  o Chronic Pancreatitis (any of the following): i. Moderate\u002Fmarked pancreas imaging morphology (i.e. ductal and parenchymal abnormalities ii. Pancreatic calcifications iii. Histologic confirmation\n\n  o Recurrent Acute Pancreatitis: i. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3:\n  1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values\n  2. characteristic cross-sectional imaging\n  3. typically upper abdominal pain according to the revised Atlanta classification\n* Currently smoking ≥ 5 cigarettes\u002Fday\n* Explicitly express a desire to quit within 30 days\n* Ability to take oral medication and be willing to adhere to the study intervention regimen\n* Willing and able to comply with trial protocol and follow-up\n\nExclusion Criteria\n\n* Age \\\u003C 18 years\n* Ongoing acute pancreatitis or prior episode of pancreatitis in previous 30 days\n* No desire to quit smoking\n* Currently undergoing smoking cessation intervention (i.e. nicotine replacement therapy, varenicline, counseling, bupropion).\n* Known allergic reactions to varenicline or bupropion SR\n* History of seizures\n* History of an eating disorder (anorexia or bulimia)\n* Closed head trauma with any loss of consciousness or amnesia in the last 5 year\n* Ever history of closed head trauma with \\> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma\u002Fbrain contusion\n* Ever history of alcohol withdrawal\n* Ever history of chronic kidney disease (creatine clearance \\\u003C 30 mL\u002Fminute)\n* Liver impairment (i.e. history of cirrhosis) with aminotransferase elevation ≥ 2 times the upper limit of normal and\u002For alkaline phosphatase elevation ≥ 2 times the upper limit of normal.\n* History of bipolar disorder or psychosis\n* Ongoing or recent use (prior 14 days) of any monoamine oxidase inhibitors (isocarboxazid, phenelzine, tranylcypromine, selegiline).\n* Regular use of potent CYP2B6 inhibitors (i.e. clopidogrel, ticlopidine)\n* Regular use of CYP2D6 substrates with narrow therapeutic indices (e.g. flecainide, propafenone, tricyclic antidepressants such as nortriptyline, thioridazine, vinblastine)\n* History of acute angle closure glaucoma\n* Meet criteria for depression as assessed by the Center for Epidemiologic Studies - Depression (CES-D) with a score of 16 or higher.\n* Psychiatric hospitalization within 1 year of screening\n* Participants who have a score of 3 or higher on the Columbus-Suicide Severity Rating Scale (C-SSRS) at enrollment or during any of the study assessments will be excluded\n* Unable to provide consent for self Incarcerated\n* Pregnant females. All female patients of childbearing potential must have a negative pregnancy test and must agree to use highly effective (failure rate \\\u003C1%) contraception during participation in the study.","ALL","18 Years",{"count":81,"type":82},45,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The purpose of this research is to assess the effectiveness of two treatment strategies for smoking cessation in patients with acute recurrent pancreatitis or chronic pancreatitis who smoke cigarettes. All participants will receive varenicline, a commonly used medication that helps people stop smoking, at its standard dose. For those who are unable to stop smoking after 6 weeks of treatment, they will be randomly selected to either 1) increase their dose of varenicline, 2) combine varenicline with bupropion (another medication that helps with smoking cessation) or continue on the standard dose of varenicline. At the end of 12 weeks of treatment, participants will be asked if they have stopped smoking with confirmation done by measuring carbon monoxide levels in their breath.",[88,89,90,91],"Pancreatitis, Chronic","Pancreatitis, Acute","Recurrent Acute Pancreatitis","Smoking (Tobacco) Addiction",[93,94,95,96,97],"Smoking cessation","chronic pancreatitis","recurrent acute pancreatitis","varenicline","bupropion","2025-11-06",{"date":100,"type":101},"2025-11-10","ACTUAL",{"date":98,"type":101},{"date":104,"type":82},"2028-10-01",{"name":5,"class":6},1]