Smoking Cessation and Menstrual Cycle Phase

NCT05515354 | Recruiting Phase 4

• 1 other identifier: 022-2022
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence; Tobacco Smoking; Smoking Cessation; Nicotine Use Disorder; Substance Use Disorders

Keywords

Menstrual Cycle; Ovarian Hormones; Smoking Cessation Treatment; Nicotine Replacement Therapy; Cancer Prevention; Randomized Controlled Trial; Estrogen; Progesterone

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence of abstinence

  Proportion of the sample that has been abstinent from smoking for 7 days at the time of assessment (i.e., managed to quit smoking on their target quit date).

  7 days post-target quit date

Secondary Outcomes (2)

• End-of-treatment 7-day point prevalence of abstinence

  6 weeks post-target quit date

• Follow-up 7-day point prevalence of abstinence

  6 months post-target quit date

Study Arms (3)

Mid-Follicular Phase Target Quit Date

EXPERIMENTAL

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.

Other: Timing of nicotine replacement therapy start date; Drug: Nicotine Replacement Therapy Agent

Mid-Luteal Phase Target Quit Date

EXPERIMENTAL

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.

Other: Timing of nicotine replacement therapy start date; Drug: Nicotine Replacement Therapy Agent

Randomly Selected Target Quit Date (Usual Care)

ACTIVE COMPARATOR

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.

Drug: Nicotine Replacement Therapy Agent

Interventions

Timing of nicotine replacement therapy start date OTHER

Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.

Also known as: Timing of target quit date

Mid-Follicular Phase Target Quit Date; Mid-Luteal Phase Target Quit Date

Nicotine Replacement Therapy Agent DRUG

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.

Also known as: Nicotine Patch, Nicotine Gum, Nicotine Lozenge

Mid-Follicular Phase Target Quit Date; Mid-Luteal Phase Target Quit Date; Randomly Selected Target Quit Date (Usual Care)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Publications (10)

• Carpenter 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 BACKGROUND

• Franklin 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 BACKGROUND

• Piper 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 BACKGROUND

• Poirier 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 BACKGROUND

• Saladin 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 BACKGROUND

• Smith 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 BACKGROUND

• Statistics 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

  BACKGROUND

• World Health Organization. (2020). Who report on cancer: Setting priorities, investing wisely and providing care for all. World Health Organization. Retrieved August 12, 2022, from https://www.who.int/publications-detail-redirect/9789240001299

  BACKGROUND

• Weinberger AH, Smith PH, Allen SS, Cosgrove KP, Saladin ME, Gray KM, Mazure CM, Wetherington CL, McKee SA. Systematic and meta-analytic review of research examining the impact of menstrual cycle phase and ovarian hormones on smoking and cessation. Nicotine Tob Res. 2015 Apr;17(4):407-21. doi: 10.1093/ntr/ntu249.

  PMID: 25762750 BACKGROUND

• Zawertailo L, Kabir T, Voci S, Tanzini E, Attwells S, Malat L, Veldhuizen S, Minian N, Dragonetti R, Melamed OC, Mei-Dan E, Selby P. Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial. Trials. 2023 Apr 1;24(1):251. doi: 10.1186/s13063-023-07196-1.

  PMID: 37005655 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Smoking; Smoking Cessation; Substance-Related Disorders

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Laurie A Zawertailo, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie A Zawertailo, PhD

CONTACT

4165358501; laurie.zawertailo@camh.ca

Tina Kabir, BMSc

CONTACT

4165358501; tina.kabir@camh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: November 30, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CA (1)