Smoking Cessation and Menstrual Cycle Phase: A Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada (Poirier et al., 2019; World Health Organization, 2020). Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke (Statistics Canada, 2020). However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men (Piper et al., 2010; Smith et al., 2016). 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 (Weinberger et al., 2015). In this study, we will test targeting the start of a quit attempt using nicotine replacement therapy (NRT) to specific phases of MC. We hypothesize 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 (Carpenter et al., 2008; Franklin et al., 2008; Weinberger et al., 2015).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: Canadian Cancer Society (CCS)
• Treatments: Nicotine

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.