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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

MC-NRT 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.Check my eligibility

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.See study design

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.

MC-NRT Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-target quit date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

7-day point prevalence of abstinence

Secondary outcome measures

End-of-treatment 7-day point prevalence of abstinence

Follow-up 7-day point prevalence of abstinence

MC-NRT 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

80,244 Total Patients Enrolled

Canadian Cancer Society (CCS)OTHER

78 Previous Clinical Trials

36,545 Total Patients Enrolled

Laurie A Zawertailo, PhDPrincipal InvestigatorCentre for Addiction and Mental Health

1 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

Nicotine Replacement Therapy Agent (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05515354 — Phase 4

Tobacco Smoking Research Study Groups: Randomly Selected Target Quit Date (Usual Care), Mid-Luteal Phase Target Quit Date, Mid-Follicular Phase Target Quit Date

Tobacco Smoking Clinical Trial 2023: Nicotine Replacement Therapy Agent Highlights & Side Effects. Trial Name: NCT05515354 — Phase 4

Nicotine Replacement Therapy Agent (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515354 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants aged 50 or above?

"This trial is open to any participant over the age of majority and below 40 years old."

Answered by AI

How prudent is initiating nicotine replacement therapy on a certain date for those receiving it?

"Based on the Phase 4 status of nicotine replacement therapy, our team has rated its safety at a 3. This stands to reason as this medication is already approved by regulatory authorities."

Answered by AI

Are there presently opportunities to participate in this research endeavor?

"Current records on clinicaltrials.gov suggest that this medical trial is not currently accepting any new participants, despite having been posted in September 2022 and edited August of the same year. Nonetheless, there are a plethora of alternative studies enrolling patients at present - 1434 to be exact!"

Answered by AI

Are there any prerequisites to participate in this experiment?

"Eligible individuals must be between 18 and 40 years old, with a history of smoking tobacco. This clinical trial seeks to enroll approximately 1200 participants."

Answered by AI