[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478851":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":75,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":57,"whyStopped":75,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Centre for Addiction and Mental Health","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Mid-Follicular Phase Target Quit Date","EXPERIMENTAL","Participants will start their quit attempts during the mid-follicular phase of their MC (6-8 days post-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.",[13,14],"Other: Timing of nicotine replacement therapy start date","Drug: Nicotine Replacement Therapy Agent",{"label":16,"type":10,"description":17,"interventionNames":18},"Mid-Luteal Phase Target Quit Date","Participants will start their quit attempts during the mid-luteal phase of their MC (6-8 days pre-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Randomly Selected Target Quit Date (Usual Care)","ACTIVE_COMPARATOR","Participants will start their quit attempts within 30 days of their enrollment into the study. They will select their target quit dates without regard for their MC. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.",[14],[25,31],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Timing of nicotine replacement therapy start date","Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.",[9,16],[30],"Timing of target quit date",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Nicotine Replacement Therapy Agent","Nicotine patch and a choice of nicotine gum or lozenge (2 mg) for 6 weeks. Participants who smoke 10 or more cigarettes per day receive a package of 21 mg, 14 mg, and 7 mg nicotine patches. For participants who smoke 5-9 (inclusive) cigarettes per day, the package contains 14 mg and 7 mg nicotine patches.",[9,16,20],[37,38,39],"Nicotine Patch","Nicotine Gum","Nicotine Lozenge",[41],{"name":42,"affiliation":5,"role":43},"Laurie A Zawertailo, PhD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","4165358501","77422","laurie.zawertailo@camh.ca",{"name":51,"role":46,"phone":47,"phoneExt":52,"email":53},"Tina Kabir, BMSc","37285","tina.kabir@camh.ca",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Centre for Addiction and Mental Health, Nicotine Dependence Clinic","RECRUITING","Toronto","Ontario","M6J 1H4","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-79.39864,43.70643,{"lat":67,"lon":66},[70,73],{"name":71,"role":46,"phone":72,"phoneExt":48,"email":49},"Laurie Zawertailo","416-535-8501",{"name":74,"role":43,"phone":75,"phoneExt":75,"email":75},"Laurie Zawertailo, PhD",null,{"type":43,"investigatorFullName":71,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":75,"oldOrganization":75},"Senior Scientist",[79],{"name":80,"class":6},"Canadian Cancer Society (CCS)","100478851","phase-4-smoking-cessation-and-menstrual-cycle-phase-100478851",false,"NCT05515354","Smoking Cessation and Menstrual Cycle Phase","Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial","MC-NRT","Inclusion Criteria:\n\n* Must provide informed consent following the CAMH REDCap e-consent framework and procedures;\n* Stated willingness to comply with all study procedures;\n* Naturally cycling individuals with regular MCs (defined as length ranging 21 to 35 days over past 6 months);\n* Daily smoker of ≥5 cigarettes per day (CPD) over past 6 months;\n* Intention to quit smoking within the next 30 days and willing to make a quit attempt on their assigned TQD;\n* Interested in using, and able to use, nicotine patches and gum or lozenge as a smoking cessation aid;\n* Willing to provide a valid e-mail address to be used for study communications and to complete online questionnaires.\n\nExclusion Criteria:\n\n* Current use of progesterone, estrogen, testosterone, or fertility treatment;\n* Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);\n* Use of hormonal contraceptives in the past 6 months (e.g., pill, patch, hormonal intrauterine device \\[IUD\\], ring);\n* Pregnancy, or trying to become pregnant in the next 2-3 months;\n* Known hypersensitivity or allergies to any of the components of the nicotine patch;\n* Daily or almost daily use of cannabis in the past 6 months;\n* Daily or almost daily use of tobacco or nicotine products other than cigarettes (e.g., smokeless tobacco, heat-not-burn products, e-cigarettes) in the past 6 months;\n* Polycystic ovary syndrome diagnosis;\n* Unstable psychiatric condition (including substance use disorder) which would compromise study compliance;\n* Life threatening arrhythmias or severe\u002Fworsening angina pectoris;\n* Myocardial infarction or cerebral vascular accident in the past 2 weeks; or\n* Diagnosed with a terminal illness.","FEMALE","18 Years","40 Years",{"count":93,"type":94},1200,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada. Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke. However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men. There is some evidence that hormonal levels and fluctuations throughout the menstrual cycle (MC) may contribute to the greater difficulty women experience when trying to quit smoking. In this study, the start of a quit attempt using nicotine replacement therapy (NRT) will be targeted to specific phases of MC. It was hypothesized that starting a quit attempt during the first half of MC (follicular phase) will result in increased quit success compared to starting during the second half of MC (luteal phase) or the usual practice of not targeting quit start date to MC phase.",[100,101,102,103,104],"Nicotine Dependence","Tobacco Smoking","Smoking Cessation","Nicotine Use Disorder","Substance Use Disorders",[106,107,108,109,110,111,112,113],"Menstrual Cycle","Ovarian Hormones","Smoking Cessation Treatment","Nicotine Replacement Therapy","Cancer Prevention","Randomized Controlled Trial","Estrogen","Progesterone","2026-03-17",{"date":116,"type":117},"2026-03-19","ACTUAL",{"date":119,"type":117},"2022-11-30",{"date":121,"type":94},"2026-12-31",{"name":5,"class":6},1]