Impact of Menstrual Cycle Phase on Smoking Cessation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: laurie.zawertailo@camh.ca
• Phone: 4165358501

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.