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Smoking Cessation and Menstrual Cycle Phase (MC-NRT)

Primary Purpose

Nicotine Dependence, Tobacco Smoking, Smoking Cessation

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Timing of nicotine replacement therapy start date
Nicotine Replacement Therapy Agent
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Menstrual Cycle, Ovarian Hormones, Smoking Cessation Treatment, Nicotine Replacement Therapy, Cancer Prevention, Randomized Controlled Trial, Estrogen, Progesterone

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health, Nicotine Dependence ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mid-Follicular Phase Target Quit Date

Mid-Luteal Phase Target Quit Date

Randomly Selected Target Quit Date (Usual Care)

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

End-of-treatment 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Follow-up 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.

Full Information

First Posted
August 23, 2022
Last Updated
January 31, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT05515354
Brief Title
Smoking Cessation and Menstrual Cycle Phase
Acronym
MC-NRT
Official Title
Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mid-Follicular Phase Target Quit Date
Arm Type
Experimental
Arm 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.
Arm Title
Mid-Luteal Phase Target Quit Date
Arm Type
Experimental
Arm 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.
Arm Title
Randomly Selected Target Quit Date (Usual Care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Timing of nicotine replacement therapy start date
Other Intervention Name(s)
Timing of target quit date
Intervention Description
Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy Agent
Other Intervention Name(s)
Nicotine Patch, Nicotine Gum, Nicotine Lozenge
Intervention Description
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 Information:
Title
7-day point prevalence of abstinence
Description
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).
Time Frame
7 days post-target quit date
Secondary Outcome Measure Information:
Title
End-of-treatment 7-day point prevalence of abstinence
Description
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Time Frame
6 weeks post-target quit date
Title
Follow-up 7-day point prevalence of abstinence
Description
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Time Frame
6 months post-target quit date

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie A Zawertailo, PhD
Phone
4165358501
Ext
77422
Email
laurie.zawertailo@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Kabir, BMSc
Phone
4165358501
Ext
37285
Email
tina.kabir@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie A Zawertailo, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo
Phone
416-535-8501
Ext
77422
Email
laurie.zawertailo@camh.ca
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18321181
Citation
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.
Results Reference
background
PubMed Identifier
18321180
Citation
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.
Results Reference
background
PubMed Identifier
20439385
Citation
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.
Results Reference
background
PubMed Identifier
31078177
Citation
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.
Results Reference
background
PubMed Identifier
25762749
Citation
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.
Results Reference
background
PubMed Identifier
27471021
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
25762750
Citation
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.
Results Reference
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Smoking Cessation and Menstrual Cycle Phase

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