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Timing of Nicotine Replacement Therapy for Smoking Cessation (MC-NRT Trial)
Phase 4
Recruiting
Led By Laurie A Zawertailo, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-target quit date
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether it's easier for women to quit smoking if they start during a specific phase of their menstrual cycle.
Who is the study for?
This trial is for Canadian women who smoke at least 5 cigarettes daily, have regular menstrual cycles without hormonal contraception use in the past 6 months, and are planning to quit smoking soon. They must be willing to try nicotine replacement therapy (patches/gum/lozenge) and not have severe health issues like recent heart attacks or unstable psychiatric conditions.
What is being tested?
The study tests if timing the start of a quit attempt with nicotine replacement therapy to certain phases of the menstrual cycle affects success rates. It compares starting during the follicular phase versus luteal phase or at any time without considering the cycle.
What are the potential side effects?
Nicotine replacement products may cause skin irritation where patches are applied, mouth/throat soreness from gum/lozenges, headaches, nausea, dizziness, and sleep disturbances. These side effects vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-target quit date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-target quit date
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
7-day point prevalence of abstinence
Secondary study objectives
End-of-treatment 7-day point prevalence of abstinence
Follow-up 7-day point prevalence of abstinence
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mid-Luteal Phase Target Quit DateExperimental Treatment2 Interventions
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.
Group II: Mid-Follicular Phase Target Quit DateExperimental Treatment2 Interventions
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.
Group III: Randomly Selected Target Quit Date (Usual Care)Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
81,491 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
82 Previous Clinical Trials
40,525 Total Patients Enrolled
Laurie A Zawertailo, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
1 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using hormone or fertility treatments.I am willing and able to use nicotine patches and gum or lozenges to quit smoking.I do not have severe heart rhythm problems or worsening chest pain.I have used hormonal contraceptives in the last 6 months.I have been diagnosed with polycystic ovary syndrome.I have smoked at least 5 cigarettes daily for the last 6 months.I am currently using smoking cessation aids.I have not had a heart attack or stroke in the last 2 weeks.I plan to quit smoking within the next month and will try to quit on my set date.My menstrual cycles are regular, lasting 21 to 35 days over the last 6 months.I have been smoking at least 5 cigarettes daily for the last 6 months.I am willing and able to use nicotine patches and gum or lozenges to quit smoking.I plan to quit smoking within the next month and will try to quit on my target quit day.
Research Study Groups:
This trial has the following groups:- Group 1: Randomly Selected Target Quit Date (Usual Care)
- Group 2: Mid-Luteal Phase Target Quit Date
- Group 3: Mid-Follicular Phase Target Quit Date
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.