Impact of Menstrual Cycle Phase on Smoking Cessation

Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial

This study tests if starting smoking cessation treatment during certain phases of the menstrual cycle helps women quit smoking more successfully.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05515354 on ClinicalTrials.gov

What this trial studies

This study investigates whether the timing of a quit attempt for smoking, aligned with the menstrual cycle phases, can improve cessation success among women. Participants will be randomized to start nicotine replacement therapy (NRT) during either the follicular or luteal phase of their menstrual cycle, or to a usual care group with no specific timing. The study aims to determine if starting during the follicular phase leads to higher quit rates compared to the other groups. Behavioral support will be provided through an online program and a downloadable app.

Who should consider this trial

Good fit: Ideal candidates are naturally cycling women who smoke at least 5 cigarettes per day and intend to quit within the next 30 days.

Not a fit: Patients currently using hormonal contraceptives or other smoking cessation medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance smoking cessation rates among women, contributing to cancer prevention efforts.

How similar studies have performed: While some studies have explored the relationship between menstrual cycle phases and smoking cessation, this study's specific approach is novel and rigorously designed.

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.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health, Nicotine Dependence Clinic — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Laurie A Zawertailo, PhD — Centre for Addiction and Mental Health
• Study coordinator: Laurie A Zawertailo, PhD

Conditions Nicotine Dependence; Tobacco Smoking; Smoking Cessation; Nicotine Use Disorder; Substance Use Disorders; Menstrual Cycle; Ovarian Hormones; Smoking Cessation Treatment