About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Timing of nicotine replacement therapy start date
  • Nicotine Replacement Therapy Agent

Treatment groups

1,200 Participants
are divided into 3 treatment groups

Locations

1
Centre for Addiction and Mental Health, Nicotine Dependence ClinicM6J 1H4, TorontoOntario, Canada

Sponsors and collaborators

Centre for Addiction and Mental Health

Lead sponsor

Canadian Cancer Society (CCS)

Collaborator