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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

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

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.

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