RecruitingPhase 4NCT05515354

Smoking Cessation and Menstrual Cycle Phase

Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial


Sponsor

Centre for Addiction and Mental Health

Enrollment

1,200 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether the phase of a woman's menstrual cycle affects her success in quitting smoking. Researchers will assign women to quit on a specific day of their cycle (either the follicular or luteal phase) to see if one phase leads to better quitting outcomes with nicotine replacement therapy (patches and gum/lozenge). **You may be eligible if...** - You have regular menstrual cycles (21–35 days long) - You smoke at least 5 cigarettes per day and have done so for the past 6 months - You intend to quit smoking within the next 30 days - You are willing to use nicotine patches and gum or lozenge to help quit - You have a valid email address for study communications **You may NOT be eligible if...** - You are currently using hormonal treatments (birth control pills, progesterone, estrogen, or fertility drugs) - You are pregnant or planning to become pregnant - You are currently taking prescription medications specifically for smoking cessation (like varenicline/Champix) - Your menstrual cycles are irregular - You do not intend to make a quit attempt Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERTiming 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.

DRUGNicotine 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05515354


Related Trials