Smoking Cessation and Menstrual Cycle Phase (NCT05515354)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).
Location: Centre for Addiction and Mental Health, Nicotine Dependence Clinic — Toronto, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current use of progesterone, estrogen, testosterone, or fertility treatment;
- Current use of nicotine replacement therapy or other smoking cessation medications (e.g., varenicline, bupropion);
- 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;
- Known hypersensitivity or allergies to any of the components of the nicotine patch;
- 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;
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Centre for Addiction and Mental Health, Nicotine Dependence Clinic — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.