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Trial Title: Smoking Cessation and Menstrual Cycle Phase

NCT ID: NCT05515354

Condition: Nicotine Dependence
Tobacco Smoking
Smoking Cessation
Nicotine Use Disorder
Substance Use Disorders

Conditions: Official terms:
Substance-Related Disorders
Tobacco Use Disorder
Nicotine

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

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Timing of nicotine replacement therapy start date
Description: Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.
Arm group label: Mid-Follicular Phase Target Quit Date
Arm group label: Mid-Luteal Phase Target Quit Date

Other name: Timing of target quit date

Intervention type: Drug
Intervention name: Nicotine Replacement Therapy Agent
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.
Arm group label: Mid-Follicular Phase Target Quit Date
Arm group label: Mid-Luteal Phase Target Quit Date
Arm group label: Randomly Selected Target Quit Date (Usual Care)

Other name: Nicotine Patch

Other name: Nicotine Gum

Other name: Nicotine Lozenge

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: 40 Years

Healthy volunteers: No

Locations:

Facility:
Name: Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Address:
City: Toronto
Zip: M6J 1H4
Country: Canada

Status: Recruiting

Contact:
Last name: Laurie Zawertailo

Phone: 416-535-8501

Phone ext: 77422
Email: laurie.zawertailo@camh.ca

Investigator:
Last name: Laurie Zawertailo, PhD
Email: Principal Investigator

Start date: November 30, 2022

Completion date: August 31, 2025

Lead sponsor:
Agency: Centre for Addiction and Mental Health
Agency class: Other

Collaborator:
Agency: Canadian Cancer Society (CCS)
Agency class: Other

Source: Centre for Addiction and Mental Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05515354

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