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New study tests if menstrual cycle timing boosts Quit-Smoking success

NCT ID NCT05515354

Disease control Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting nicotine replacement therapy (patches, gum, or lozenges) at a specific time in the menstrual cycle helps women quit smoking. About 1,200 women who smoke daily and have regular periods will be assigned to start their quit attempt during the follicular phase, luteal phase, or at their usual time. The goal is to see if cycle-timed quitting leads to higher abstinence rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine replacement therapy (patch, gum, lozenge)
What this could lead to
If successful, this could show that timing quit attempts to the menstrual cycle improves smoking cessation rates in women.
What could go wrong
This is a large Phase 4 trial, but the effect may be small or not generalizable to all women. Success depends on adherence and individual cycle variability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Cessation substance-related disorder Tobacco Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nicotine dependence Nicotine use disorder Smoking cessation Substance use disorders Tobacco smoking

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Addiction and Mental Health, Nicotine Dependence Clinic

    RECRUITING

    Toronto, Ontario, M6J 1H4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.