NCT05515354RecruitingPhase 4
Smoking Cessation and Menstrual Cycle Phase
Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 30 Nov 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Centre for Addiction and Mental Health
- NCT number
- NCT05515354
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1200
- From 30 Nov 2022 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);
Other illness
- Known hypersensitivity or allergies to any of the components of the nicotine patch;
- Polycystic ovary syndrome diagnosis;
- Unstable psychiatric condition (including substance use disorder) which would compromise study compliance;
- Life threatening arrhythmias or severe/worsening angina pectoris;
- Myocardial infarction or cerebral vascular accident in the past 2 weeks; or
- Diagnosed with a terminal illness.
Other
- Current use of progesterone, estrogen, testosterone, or fertility treatment;
- Use of hormonal contraceptives in the past 6 months (e.g., pill, patch, hormonal intrauterine device \[IUD\], ring);
- Pregnancy, or trying to become pregnant in the next 2-3 months;
- Daily or almost daily use of cannabis in the past 6 months;
- 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;
Who the study is looking for
- Must provide informed consent following the CAMH REDCap e-consent framework and procedures;
- Stated willingness to comply with all study procedures;
- Naturally cycling individuals with regular MCs (defined as length ranging 21 to 35 days over past 6 months);
- Daily smoker of ≥5 cigarettes per day (CPD) over past 6 months;
- Intention to quit smoking within the next 30 days and willing to make a quit attempt on their assigned TQD;
- Interested in using, and able to use, nicotine patches and gum or lozenge as a smoking cessation aid;
- Willing to provide a valid e-mail address to be used for study communications and to complete online questionnaires.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health, Nicotine Dependence Clinic Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.