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Smoking Cessation and Menstrual Cycle Phase
Sponsor: Centre for Addiction and Mental Health
Summary
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.
Official title: Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2022-11-30
Completion Date
2026-12-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Timing of nicotine replacement therapy start date
Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.
Nicotine Replacement Therapy Agent
Nicotine patch and a choice of nicotine gum or lozenge (2 mg) for 6 weeks. Participants who smoke 10 or more cigarettes per day receive a package of 21 mg, 14 mg, and 7 mg nicotine patches. For participants who smoke 5-9 (inclusive) cigarettes per day, the package contains 14 mg and 7 mg nicotine patches.
Locations (1)
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, Canada