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.
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;
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;
Parallel
Timing of nicotine replacement therapy start date
Other interventionNicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.
Nicotine Replacement Therapy Agent
DrugNicotine 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.
7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for 7 days at the time of assessment (i.e., managed to quit smoking on their target quit date).
End-of-treatment 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Follow-up 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
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Centre for Addiction and Mental Health
Lead sponsor
Canadian Cancer Society (CCS)
Collaborator
