Smoking Cessation and Menstrual Cycle Phase (MC-NRT)

January 31, 2023 updated by: Laurie Zawertailo, Centre for Addiction and Mental Health

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Evidence for the influence of the menstrual cycle (MC) phase on smoking cessation outcomes is contradictory and has been limited by small samples and a lack of clarity surrounding ideal quit date timing. Therefore, this large rigorously designed study aims to clarify whether targeting quit date to either the follicular or luteal phase of MC improves quit success. The primary hypothesis states that participants assigned a TQD in the follicular phase of their MC will be more likely to have quit successfully on day 7 of treatment than participants setting their own TQD (usual care). Quit rates at the end of treatment and 6 months post-TQD were identified as secondary objectives.

Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. Participants will receive a 6-week supply of NRT consisting of nicotine patch plus their choice of nicotine gum or lozenge, which the participants will be instructed to start on their target quit date (TQD). Eligible individuals will be randomized to a TQD: [1] during the mid-luteal phase of their MC (6-8 days pre-onset of menses), [2] during the mid-follicular phase of their MC (6-8 days post-onset of menses), or [3] within 30 days of enrollment with no regard to MC phase (usual care). Behavioural support will consist of a free downloadable app (My Change Plan) and brief videos delivered via e-mail. These videos will be produced by the CAMH Nicotine Dependence Service and will focus on health behavior change strategies such as building a quit plan, coping with cravings, and relapse prevention.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Centre for Addiction and Mental Health, Nicotine Dependence Clinic
        • Contact:
        • Principal Investigator:
          • Laurie Zawertailo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Other Names:
  • Timing of target quit date
Drug: 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.
Other Names:
  • Nicotine Gum
  • Nicotine Patch
  • Nicotine Lozenge
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.
Other: 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.
Other Names:
  • Timing of target quit date
Drug: 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.
Other Names:
  • Nicotine Gum
  • Nicotine Patch
  • Nicotine Lozenge
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.
Drug: 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.
Other Names:
  • Nicotine Gum
  • Nicotine Patch
  • Nicotine Lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence of abstinence
Time Frame: 7 days post-target quit date
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-of-treatment 7-day point prevalence of abstinence
Time Frame: 6 weeks post-target quit date
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
6 weeks post-target quit date
Follow-up 7-day point prevalence of abstinence
Time Frame: 6 months post-target quit date
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
6 months post-target quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Cancer Society (CCS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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