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Smoking Cessation and Menstrual Cycle Phase

Study acronym: MC-NRT
StatusRecruiting
PhasePhase 4
Started2022-11-30
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 19, 2026 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-17
minor
Study Status v2
Primary completion date2024-08-31→2026-04-30
Completion date2025-08-31→2026-12-31
2023-01-31
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09-06→confirmed 2022-11-30
Study description-100 characters
[...] les and a lack of clarity surrounding ideal quit date timing (Carpenter et al., 2008; Franklin et al., 2008; Saladin et al., 2015; Weinberger et al., 2015). Therefore, we plan to conduct athis large, rigorously designed study aims to clarify whether targeting quit date to either the follic [...] tment than participants setting their own TQD (usual care). AsQuit secondary objectives, we are aiming to study quitrates at the end of treatment and 6 months post-TQD were identified as secondary objectives. Participants will enroll in an online smoking cessation pr [...] e patch plus their choice of nicotine gum o [...]
Study sitesdetails revised at 1 of 1 site
Study title-31 characters
Smoking Cessation and Menstrual Cycle Phase: A Randomized Controlled Trial
2022-08-23
minor
Original filing
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.
Trial Details
NCT Number NCT05515354
Lead Sponsor Centre for Addiction and Mental Health
Collaborators: Canadian Cancer Society (CCS)
Conditions Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Substance Use Disorders
Enrollment 1,200 participants
Start Date 2022-11-30
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-19