NCT05515354 Smoking Cessation and Menstrual Cycle Phase
| NCT ID | NCT05515354 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,200 participants in total. It began in 2022-11-30 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. 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 * Diagnosed with a terminal illness.
Contact & Investigator
Laurie A Zawertailo, PhD
PRINCIPAL INVESTIGATOR
Centre for Addiction and Mental Health
Frequently Asked Questions
Who can join the NCT05515354 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05515354 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05515354 currently recruiting?
Yes, NCT05515354 is actively recruiting participants. Contact the research team at laurie.zawertailo@camh.ca for enrollment information.
Where is the NCT05515354 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05515354 clinical trial?
NCT05515354 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Laurie A Zawertailo, PhD at Centre for Addiction and Mental Health. The trial plans to enroll 1,200 participants.