[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623091":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":43,"locations":32,"responsibleParty":53,"collaborators":32,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":32,"enrollmentInfo":65,"targetDuration":32,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":76,"whyStopped":32,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":32},{"fullName":5,"class":6},"Achieve Life Sciences","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","PLACEBO_COMPARATOR","12 weeks of placebo + behavioral support; 400 subjects",[13,14],"Drug: Placebo","Behavioral: Behavioral Support",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B","ACTIVE_COMPARATOR","12 weeks cytisinicline + behavioral support; 400 subjects",[20,14],"Drug: Cytisinicline",[22,29,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Cytisinicline","Tablet, 3 times a day (TID), 12 weeks",[16],[28],"cytisine",{"type":23,"name":30,"description":25,"armGroupLabels":31,"otherNames":32},"Placebo",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Behavioral Support","16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period.",[9,16],[39],{"name":40,"affiliation":41,"role":42},"Julie Ball","Achieve Life Sciences, Inc.","STUDY_DIRECTOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":32,"email":48},"Julie Ball; Vice President, Clinical Operations","CONTACT","425-686-1540","jball@achievelifesciences.com",{"name":50,"role":46,"phone":51,"phoneExt":32,"email":52},"Roxann Becco; Sr. Director, Clinical Operations","312-288-1187","rbecco@achievelifesciences.com",{"type":54,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100623091","phase-3-phase-3-trial-evaluating-the-efficacy-and-safety-of-cytisinicline-for-vaping-cessation-in-adults-using-nicotine-containing-e-cigarettes-100623091",false,"NCT07392125","Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes","A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes","ORCA-V2","Inclusion Criteria:\n\n* Male or female subjects, age ≥18 years.\n* Test positive for cotinine using a point-of-care Oral Fluid Screening Device (OFD) with positive detection at ≥30 ng\u002FmL cotinine.\n* Current daily nicotine-containing electronic cigarette usage as recorded in a screening diary for at least 7 consecutive days. Willing to bring the e-cigarette or nicotine device used to the clinical site so that the specific product type, flavor, and nicotine level can be documented.\n* Failed at least one previous attempt to stop vaping with or without therapeutic support.\n* Willing to initiate study treatment on the day after randomization and set a quit date within Day 7 and Day 14.\n* Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study.\n* Able to fully understand study requirements, willing to participate, and comply with dosing schedule.\n* Sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Currently smoking or having smoked within 3 months prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products such as heat not burn products or nicotine pouches (ie, dual users).\n* Currently smoking\u002Fvaping cannabis or having smoked or vaped cannabis within 4 weeks (28 days) prior to study randomization or planned use while on study. Other methods of cannabis consumption, eg, edibles, tinctures, capsules, topicals, etc. are allowed.\n* Expired Carbon Monoxide (CO) levels ≥6 ppm, indicating recent combustible tobacco or cannabis smoking.\n* A score of 0-3 on the Penn State e-Cigarette Dependence Index indicating no dependence.\n* More than 1 study subject in same household during the study treatment period.\n* Known hypersensitivity to any of the excipients, previous cytisinicline treatment in a prior clinical study, or any previous use of cytisinicline.\n* Positive urinary drugs of abuse screen determined within 28 days before the first dose of study drug. (Note: Although THC is part of the standard drug screen, it is not necessarily exclusionary. Refer to exclusion criteria #2).\n* Clinically significant abnormal serum chemistry or hematology values, as determined by the investigator, within 28 days of randomization.\n* Clinically significant abnormalities on screening visit 12-lead ECG, as determined by the investigator, after minimum of 5 minutes in supine position within 28 days of randomization.\n* Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.\n* Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).\n* Currently psychotic or having had a psychotic event in the 3 months prior to the screening visit. If any subject becomes psychotic during the study, they must be removed from treatment and\u002For additional study visits.\n* Currently having suicidal ideation or risk for suicide (YES to either question 3, 4 or 5 OR YES to any suicidal behavior question on the C-SSRS with clear suicidal intent or suicide attempt within the last 10 years).\n* Current symptoms of moderate to severe depression (depression score ≥11 using depression questions on the Hospital Anxiety and Depression Scale \\[HADS\\] at screening visit).\n* Renal impairment defined as a creatinine clearance (CrCl) \\\u003C60 mL\u002Fmin at screening visit (estimated with the Cockroft-Gault equation and reported by the central laboratory).\n* Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.0 x the upper limit of normal (ULN) at screening visit.\n* Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (eg, pneumonia, product-use associated lung injury or EVALI, etc).\n* Women who are pregnant or breast-feeding.\n* Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:\n* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \\[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Barrier methods:\n* diaphragm\n* cervical cap\n* contraceptive sponge\n* intrauterine device (IUD)\n* double barrier method (condom with spermicide)\n* Hormonal methods:\n* Oral contraceptives\n* Vaginal ring such as NuvaRing\n* Skin patch such as Xulane\n* Injection such as Depro-Provera\n* Implantable rod such as Nexplanon\n* Intrauterine device (IUD)\n* Participation in a clinical study with an investigational drug or biologic in the 4 weeks prior to study randomization.\n* Use of any smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy \\[NRT\\]) in the 4 weeks prior to study randomization or planned use of these or other nicotine replacement medications during the study.\n* Any planned use during the study of combustible cigarettes or other nicotine-containing, non-vaping products (eg, pipe tobacco, cigars, snuff, smokeless tobacco, hookah, ZYN pouches, etc).\n* Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.","ALL","18 Years",{"count":66,"type":67},800,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only.\n\nA total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms:\n\n* Arm B, 12 weeks cytisinicline + behavior support: N=400 or\n* Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).",[73],"Vaping Cessation",[75],"vaping cessation","NOT_YET_RECRUITING","2026-01-29",{"date":79,"type":80},"2026-02-06","ACTUAL",{"date":82,"type":67},"2026-05-15",{"date":84,"type":67},"2027-09-30",{"name":5,"class":6}]