Smoking Cessation and Menstrual Cycle Phase

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.

NCT Number	NCT05515354
Lead Sponsor	Centre for Addiction and Mental Health Collaborators: Canadian Cancer Society (CCS)
Conditions	Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Substance Use Disorders
Enrollment	1,200 participants
Start Date	2022-11-30
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-19