drugset / Trial / NCT05515354

Smoking Cessation and Menstrual Cycle Phase

NCT05515354

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-11-30
Primary completion
2026-04-30
Completion
2026-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 2 mg Oral
Subject Nicotine Unknown 7 mg Oral
Subject Nicotine Unknown 14 mg Oral
Subject Nicotine Unknown 21 mg Oral

Indications