Smoking Cessation and Menstrual Cycle Phase

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men.

It had three arms (groups): Mid-Follicular Phase Target Quit Date (experimental), Mid-Luteal Phase Target Quit Date (experimental) and Randomly Selected Target Quit Date (Usual Care) (active comparator).

Participants will start their quit attempts during the mid-follicular phase of their MC (6-8 days post-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

Participants will start their quit attempts during the mid-luteal phase of their MC (6-8 days pre-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

Participants will start their quit attempts within 30 days of their enrollment into the study. They will select their target quit dates without regard for their MC. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

The registry classes the interventions as drug and other.

More on the Plan

Evidence for the influence of the menstrual cycle (MC) phase on smoking cessation outcomes is contradictory and has been limited by small samples and a lack of clarity surrounding ideal quit date timing.

The primary hypothesis states that participants assigned a TQD in the follicular phase of their MC will be more likely to have quit successfully on day 7 of treatment than participants setting their own TQD (usual care).

Quit rates at the end of treatment and 6 months post-TQD were identified as secondary objectives.

Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support.

Who Took Part

The registry lists 1200 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: 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);.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-11-30 with completion listed for 2026-04-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 7-day point prevalence of abstinence (time frame: 7 days post-target quit date).

It also tracked 2 secondary outcomes, for example End-of-treatment 7-day point prevalence of abstinence and Follow-up 7-day point prevalence of abstinence.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1200 people.

With 1200 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.