Actively Recruiting
Smoking Cessation and Menstrual Cycle Phase
Led by Centre for Addiction and Mental Health · Updated on 2026-03-19
1200
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
C
Canadian Cancer Society (CCS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Smoking Cessation and Menstrual Cycle Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent following CAMH REDCap e-consent procedures
- Willingness to comply with all study procedures
- Naturally cycling females with regular menstrual cycles of 21 to 35 days over the past 6 months
- Daily smoker of 5 or more cigarettes per day over the past 6 months
- Intend to quit smoking within the next 30 days and willing to quit on assigned target quit date
- Interested in and able to use nicotine patches plus gum or lozenge for smoking cessation
- Willing to provide a valid email address for study communications and online questionnaires
You will not qualify if you...
- Current use of progesterone, estrogen, testosterone, or fertility treatments
- Current use of nicotine replacement therapy or other smoking cessation medications such as varenicline or bupropion
- Use of hormonal contraceptives in the past 6 months, including pill, patch, hormonal IUD, or ring
- Pregnancy or trying to become pregnant in the next 2 to 3 months
- Known allergies to any component of the nicotine patch
- Daily or almost daily cannabis use in the past 6 months
- Daily or almost daily use of tobacco or nicotine products other than cigarettes in the past 6 months
- Diagnosis of polycystic ovary syndrome
- Unstable psychiatric conditions including substance use disorders that could affect compliance
- Life-threatening heart arrhythmias or severe/worsening angina
- Myocardial infarction or stroke within the past 2 weeks
- Diagnosed with a terminal illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, Canada, M6J 1H4
Actively Recruiting
Research Team
L
Laurie A Zawertailo, PhD
CONTACT
T
Tina Kabir, BMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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