Clinical trial · Interventional

Smoking Cessation and Menstrual Cycle Phase

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

NCT05515354CI-TRIAL-00105999MC-NRTrecruitingPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Nicotine Dependence	—	UNRESOLVED	—
Nicotine Use Disorder	—	UNRESOLVED	—
Smoking Cessation	—	UNRESOLVED	—
Substance Use Disorders	—	UNRESOLVED	—
Tobacco Smoking	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Nicotine Replacement Therapy Agent	Drug	—	UNRESOLVED
Timing of nicotine replacement therapy start date	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Mid-Follicular Phase Target Quit Date
description
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.
interventionNames
1. Other: Timing of nicotine replacement therapy start date
2. Drug: Nicotine Replacement Therapy Agent
type
EXPERIMENTAL
label
Mid-Luteal Phase Target Quit Date
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years

Show eligibility criteria text

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.

References

Publications (10)

BACKGROUNDCarpenter MJ, Saladin ME, Leinbach AS, Larowe SD, Upadhyaya HP. Menstrual phase effects on smoking cessation: a pilot feasibility study. J Womens Health (Larchmt). 2008 Mar;17(2):293-301. doi: 10.1089/jwh.2007.0415. PMID 18321181
BACKGROUNDFranklin TR, Ehrman R, Lynch KG, Harper D, Sciortino N, O'Brien CP, Childress AR. Menstrual cycle phase at quit date predicts smoking status in an NRT treatment trial: a retrospective analysis. J Womens Health (Larchmt). 2008 Mar;17(2):287-92. doi: 10.1089/jwh.2007.0423. PMID 18321180
BACKGROUNDPiper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Bolt DM, Loh WY. Gender, race, and education differences in abstinence rates among participants in two randomized smoking cessation trials. Nicotine Tob Res. 2010 Jun;12(6):647-57. doi: 10.1093/ntr/ntq067. Epub 2010 May 3. PMID 20439385
BACKGROUNDPoirier AE, Ruan Y, Grevers X, Walter SD, Villeneuve PJ, Friedenreich CM, Brenner DR; ComPARe Study Team. Estimates of the current and future burden of cancer attributable to active and passive tobacco smoking in Canada. Prev Med. 2019 May;122:9-19. doi: 10.1016/j.ypmed.2019.03.015. PMID 31078177
BACKGROUNDSaladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015 Apr;17(4):398-406. doi: 10.1093/ntr/ntu262. PMID 25762749
BACKGROUNDSmith PH, Bessette AJ, Weinberger AH, Sheffer CE, McKee SA. Sex/gender differences in smoking cessation: A review. Prev Med. 2016 Nov;92:135-140. doi: 10.1016/j.ypmed.2016.07.013. Epub 2016 Jul 26. PMID 27471021
BACKGROUNDStatistics Canada. (2020). Smokers, by age group. Retrieved August 23, 2021, from https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310009610&pickMembers%5B0%5D=1.1&pickMembers%5B1%5D=3.3&cubeTimeFrame.startYear=2018&cubeTimeFrame.endYear=2019&referencePeriods=20180101%2C20190101

Registry

Dates and enrollment

Start: Nov 30, 2022
Primary completion: Apr 30, 2026
Completion: Dec 31, 2026
First posted: Aug 25, 2022
Last update posted: Mar 19, 2026
Enrollment: 1,200 (estimated)
Lead sponsor: Centre for Addiction and Mental Health OTHER
Collaborators: Canadian Cancer Society (CCS)
Keywords: Menstrual Cycle, Ovarian Hormones, Smoking Cessation Treatment, Nicotine Replacement Therapy, Cancer Prevention, Randomized Controlled Trial, Estrogen, Progesterone

Data updated 22 days agoSource updated Mar 19, 2026source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Canada	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.