Smoking Cessation and Menstrual Cycle Phase

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.

Conditions

• Nicotine Dependence
• Tobacco Smoking
• Smoking Cessation
• Nicotine Use Disorder
• Substance Use Disorders

Interventions

OTHER

Timing of nicotine replacement therapy start date

Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.

DRUG

Nicotine Replacement Therapy Agent

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.

Sponsors & Collaborators

• Canadian Cancer Society (CCS)

  collaborator OTHER

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Laurie A Zawertailo, PhD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-30

Primary Completion

2026-04-30

Completion

2026-12-31

Countries

• Canada

Study Locations