Smoking Cessation and Menstrual Cycle Phase

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Aug 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the timing of a quit smoking attempt in relation to a woman's menstrual cycle might affect her success in stopping smoking. Researchers believe that starting to quit during the first half of the menstrual cycle, when hormone levels may be more favorable, could help women quit smoking more successfully than if they start at other times or without considering their cycle. The study aims to help improve smoking cessation strategies for women, as they often find it harder to quit compared to men.

To participate in this trial, women aged between 18 and 45 who smoke at least five cigarettes a day and are planning to quit within the next month may be eligible. Participants should have regular menstrual cycles and be willing to use nicotine replacement therapies like patches, gum, or lozenges. If you decide to join, you will receive support for your quit attempt and will be asked to complete some online questionnaires. Importantly, you must not be using certain hormonal treatments or other smoking cessation medications. This trial could provide valuable insights into helping women quit smoking more effectively.

Gender

FEMALE

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.