BridgeMD
New treatment option for Nicotine Dependence
Official title Smoking Cessation and Menstrual Cycle Phase
ClinicalTrials.gov ID: NCT05515354
What this study is testing
What is Nicotine Replacement Therapy Agent?
Nicotine Replacement Therapy Agent is an investigational medicine, being studied as a potential treatment for nicotine dependence.
Also referred to as Nicotine Patch, Nicotine Gum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.