Recruiting

Smoking Cessation

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05515354

Conditions

Nicotine Dependence

Tobacco Smoking

Smoking Cessation

Nicotine Use Disorder

Substance Use Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Timing of nicotine replacement therapy start date

Nicotine Replacement Therapy Agent

Study Details

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

Study ID

NCT05515354

Start date

Nov 30, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mid-Follicular Phase Target Quit Date

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.

experimental: Mid-Luteal Phase Target Quit Date

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.

active comparator: Randomly Selected Target Quit Date (Usual Care)

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.

Interventions

Timing of nicotine replacement therapy start date

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

Nicotine Replacement Therapy Agent

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.

Primary outcome measure

  • 7-day point prevalence of abstinence [ Time Frame: 7 days post-target quit date ]

Central Contacts and Locations

Central contacts

Laurie A Zawertailo, PhD

4165358501laurie.zawertailo@camh.ca

Tina Kabir, BMSc

4165358501tina.kabir@camh.ca

Locations

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Laurie Zawertailo

416-535-8501laurie.zawertailo@camh.ca

Principal Investigator:

Laurie Zawertailo, PhD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-19.