Nicotine DependencePhase 4MC-NRTNCT05515354
Smoking Cessation and Menstrual Cycle Phase
A Phase 4 study testing Timing of nicotine replacement therapy start date and Nicotine Replacement Therapy Agent in people with Nicotine Dependence and Tobacco Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation
- What is being tested?
- Timing of nicotine replacement therapy start date and Nicotine Replacement Therapy Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, M6J 1H4
Laurie Zawertailo, 416-535-8501 ext. 77422, laurie.zawertailo@camh.ca
Laurie Zawertailo, PhD
About this study
Official title: Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial
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.
Read the detailed description
Evidence for the influence of the menstrual cycle (MC) phase on smoking cessation outcomes is contradictory and has been limited by small samples and a lack of clarity surrounding ideal quit date timing. Therefore, this large rigorously designed study aims to clarify whether targeting quit date to either the follicular or luteal phase of MC improves quit success. The primary hypothesis states that participants assigned a TQD in the follicular phase of their MC will be more likely to have quit successfully on day 7 of treatment than participants setting their own TQD (usual care). Quit rates at the end of treatment and 6 months post-TQD were identified as secondary objectives.
Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. Participants will receive a 6-week supply of NRT consisting of nicotine patch plus their choice of nicotine gum or lozenge, which the participants will be instructed to start on their target quit date (TQD). Eligible individuals will be randomized to a TQD: [1] during the mid-luteal phase of their MC (6-8 days pre-onset of menses), [2] during the mid-follicular phase of their MC (6-8 days post-onset of menses), or [3] within 30 days of enrollment with no regard to MC phase (usual care). Behavioural support will consist of a free downloadable app (My Change Plan) and brief videos delivered via e-mail. These videos will be produced by the CAMH Nicotine Dependence Service and will focus on health behavior change strategies such as building a quit plan, coping with cravings, and relapse prevention.
- Conditions
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Substance Use Disorders
- Being tested
- Timing of nicotine replacement therapy start date, Nicotine Replacement Therapy Agent
- Keywords
- Menstrual Cycle, Ovarian Hormones, Smoking Cessation Treatment, Nicotine Replacement Therapy, Cancer Prevention, Randomized Controlled Trial, Estrogen, Progesterone
- Medical subject headings
- Tobacco Use Disorder, Tobacco Smoking, Smoking Cessation, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of nicotine replacement therapy start dateOther
Also called Timing of target quit date
Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.
Nicotine Replacement Therapy AgentDrug
Also called Nicotine Patch, Nicotine Gum, Nicotine Lozenge
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.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Follicular Phase Target Quit Date | Experimental | 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. Receives: Other: Timing of nicotine replacement therapy start date; Drug: Nicotine Replacement Therapy Agent |
| Mid-Luteal Phase Target Quit Date | Experimental | 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. Receives: Other: Timing of nicotine replacement therapy start date; Drug: Nicotine Replacement Therapy Agent |
| Randomly Selected Target Quit Date (Usual Care) | Active comparator | 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. Receives: Drug: Nicotine Replacement Therapy Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for 7 days at the time of assessment (i.e., managed to quit smoking on their target quit date).
Measured: 7 days post-target quit date
Secondary outcomes (2)
End-of-treatment 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Measured: 6 weeks post-target quit date
Follow-up 7-day point prevalence of abstinence
Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.
Measured: 6 months post-target quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start30 Nov 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Laurie A Zawertailo, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515354
- Sponsor's protocol ID
- 022-2022
- Acronym
- MC-NRT
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carpenter MJ, Saladin ME, Leinbach AS, Larowe SD, Upadhyaya HP. Menstrual phase effects on smoking cessation: a pilot feasibility study. J Womens Health (Larchmt). 2008 Mar;17(2):293-301. doi: 10.1089/jwh.2007.0415.
PubMed 18321181Franklin TR, Ehrman R, Lynch KG, Harper D, Sciortino N, O'Brien CP, Childress AR. Menstrual cycle phase at quit date predicts smoking status in an NRT treatment trial: a retrospective analysis. J Womens Health (Larchmt). 2008 Mar;17(2):287-92. doi: 10.1089/jwh.2007.0423.
PubMed 18321180Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Bolt DM, Loh WY. Gender, race, and education differences in abstinence rates among participants in two randomized smoking cessation trials. Nicotine Tob Res. 2010 Jun;12(6):647-57. doi: 10.1093/ntr/ntq067. Epub 2010 May 3.
PubMed 20439385Poirier AE, Ruan Y, Grevers X, Walter SD, Villeneuve PJ, Friedenreich CM, Brenner DR; ComPARe Study Team. Estimates of the current and future burden of cancer attributable to active and passive tobacco smoking in Canada. Prev Med. 2019 May;122:9-19. doi: 10.1016/j.ypmed.2019.03.015.
PubMed 31078177Saladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015 Apr;17(4):398-406. doi: 10.1093/ntr/ntu262.
PubMed 25762749Smith PH, Bessette AJ, Weinberger AH, Sheffer CE, McKee SA. Sex/gender differences in smoking cessation: A review. Prev Med. 2016 Nov;92:135-140. doi: 10.1016/j.ypmed.2016.07.013. Epub 2016 Jul 26.
PubMed 27471021Statistics Canada. (2020). Smokers, by age group. Retrieved August 23, 2021, from https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310009610&pickMembers%5B0%5D=1.1&pickMembers%5B1%5D=3.3&cubeTimeFrame.startYear=2018&cubeTimeFrame.endYear=2019&referencePeriods=20180101%2C20190101
World Health Organization. (2020). Who report on cancer: Setting priorities, investing wisely and providing care for all. World Health Organization. Retrieved August 12, 2022, from https://www.who.int/publications-detail-redirect/9789240001299
Weinberger AH, Smith PH, Allen SS, Cosgrove KP, Saladin ME, Gray KM, Mazure CM, Wetherington CL, McKee SA. Systematic and meta-analytic review of research examining the impact of menstrual cycle phase and ovarian hormones on smoking and cessation. Nicotine Tob Res. 2015 Apr;17(4):407-21. doi: 10.1093/ntr/ntu249.
PubMed 25762750Zawertailo L, Kabir T, Voci S, Tanzini E, Attwells S, Malat L, Veldhuizen S, Minian N, Dragonetti R, Melamed OC, Mei-Dan E, Selby P. Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial. Trials. 2023 Apr 1;24(1):251. doi: 10.1186/s13063-023-07196-1.
PubMed 37005655
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05515354
- Acronym / sponsor ID
- MC-NRT / 022-2022
- Conditions
- Nicotine Dependence, Tobacco Smoking, Smoking Cessation, Nicotine Use Disorder, Substance Use Disorders
- Keywords
- Menstrual Cycle, Ovarian Hormones, Smoking Cessation Treatment, Nicotine Replacement Therapy, Cancer Prevention, Randomized Controlled Trial, Estrogen, Progesterone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evidence for the influence of the menstrual cycle (MC) phase on smoking cessation outcomes is contradictory and has been limited by small samples and a lack of clarity surrounding ideal quit date timing. Therefore, this large rigorously designed study aims to clarify whether targeting quit date to either the follicular or luteal phase of MC improves quit success. The primary hypothesis states that participants assigned a TQD in the follicular phase of their MC will be more likely to have quit successfully on day 7 of treatment than participants setting their own TQD (usual care). Quit rates at the end of treatment and 6 months post-TQD were identified as secondary objectives.
Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. Participants will receive a 6-week supply of NRT consisting of nicotine patch plus their choice of nicotine gum or lozenge, which the participants will be instructed to start on their target quit date (TQD). Eligible individuals will be randomized to a TQD: [1] during the mid-luteal phase of their MC (6-8 days pre-onset of menses), [2] during the mid-follicular phase of their MC (6-8 days post-onset of menses), or [3] within 30 days of enrollment with no regard to MC phase (usual care). Behavioural support will consist of a free downloadable app (My Change Plan) and brief videos delivered via e-mail. These videos will be produced by the CAMH Nicotine Dependence Service and will focus on health behavior change strategies such as building a quit plan, coping with cravings, and relapse prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mid-Follicular Phase Target Quit Date | Experimental | Other: Timing of nicotine replacement therapy start date, Drug: Nicotine Replacement Therapy AgentParticipants 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. |
| Mid-Luteal Phase Target Quit Date | Experimental | Other: Timing of nicotine replacement therapy start date, Drug: Nicotine Replacement Therapy AgentParticipants 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. |
| Randomly Selected Target Quit Date (Usual Care) | Active comparator | Drug: Nicotine Replacement Therapy AgentParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of nicotine replacement therapy start dateAlso: Timing of target quit dateNicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle. | Other | Mid-Follicular Phase Target Quit Date, Mid-Luteal Phase Target Quit Date |
| Nicotine Replacement Therapy AgentAlso: Nicotine Patch, Nicotine Gum, Nicotine LozengeNicotine 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. | Drug | Mid-Follicular Phase Target Quit Date, Mid-Luteal Phase Target Quit Date, Randomly Selected Target Quit Date (Usual Care) |
Primary outcome
7-day point prevalence of abstinence
Time frame: 7 days post-target quit date
Proportion of the sample that has been abstinent from smoking for 7 days at the time of assessment (i.e., managed to quit smoking on their target quit date).
2 secondary outcomes
End-of-treatment 7-day point prevalence of abstinence
Time frame: 6 weeks post-target quit date
Follow-up 7-day point prevalence of abstinence
Time frame: 6 months post-target quit date
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 18321181Carpenter MJ, Saladin ME, Leinbach AS, Larowe SD, Upadhyaya HP. Menstrual phase effects on smoking cessation: a pilot feasibility study. J Womens Health (Larchmt). 2008 Mar;17(2):293-301. doi: 10.1089/jwh.2007.0415.
- Background: PubMed 18321180Franklin TR, Ehrman R, Lynch KG, Harper D, Sciortino N, O'Brien CP, Childress AR. Menstrual cycle phase at quit date predicts smoking status in an NRT treatment trial: a retrospective analysis. J Womens Health (Larchmt). 2008 Mar;17(2):287-92. doi: 10.1089/jwh.2007.0423.
- Background: PubMed 20439385Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Bolt DM, Loh WY. Gender, race, and education differences in abstinence rates among participants in two randomized smoking cessation trials. Nicotine Tob Res. 2010 Jun;12(6):647-57. doi: 10.1093/ntr/ntq067. Epub 2010 May 3.
- Background: PubMed 31078177Poirier AE, Ruan Y, Grevers X, Walter SD, Villeneuve PJ, Friedenreich CM, Brenner DR; ComPARe Study Team. Estimates of the current and future burden of cancer attributable to active and passive tobacco smoking in Canada. Prev Med. 2019 May;122:9-19. doi: 10.1016/j.ypmed.2019.03.015.
- Background: PubMed 25762749Saladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015 Apr;17(4):398-406. doi: 10.1093/ntr/ntu262.
- Background: PubMed 27471021Smith PH, Bessette AJ, Weinberger AH, Sheffer CE, McKee SA. Sex/gender differences in smoking cessation: A review. Prev Med. 2016 Nov;92:135-140. doi: 10.1016/j.ypmed.2016.07.013. Epub 2016 Jul 26.
- BackgroundStatistics Canada. (2020). Smokers, by age group. Retrieved August 23, 2021, from https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=1310009610&pickMembers%5B0%5D=1.1&pickMembers%5B1%5D=3.3&cubeTimeFrame.startYear=2018&cubeTimeFrame.endYear=2019&referencePeriods=20180101%2C20190101
- BackgroundWorld Health Organization. (2020). Who report on cancer: Setting priorities, investing wisely and providing care for all. World Health Organization. Retrieved August 12, 2022, from https://www.who.int/publications-detail-redirect/9789240001299
- Background: PubMed 25762750Weinberger AH, Smith PH, Allen SS, Cosgrove KP, Saladin ME, Gray KM, Mazure CM, Wetherington CL, McKee SA. Systematic and meta-analytic review of research examining the impact of menstrual cycle phase and ovarian hormones on smoking and cessation. Nicotine Tob Res. 2015 Apr;17(4):407-21. doi: 10.1093/ntr/ntu249.
- Derived from this study: PubMed 37005655Zawertailo L, Kabir T, Voci S, Tanzini E, Attwells S, Malat L, Veldhuizen S, Minian N, Dragonetti R, Melamed OC, Mei-Dan E, Selby P. Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial. Trials. 2023 Apr 1;24(1):251. doi: 10.1186/s13063-023-07196-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurie A Zawertailo, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timing of nicotine replacement therapy start date and Nicotine Replacement Therapy Agent in people with Nicotine Dependence and Tobacco Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie A Zawertailo, PhD (4165358501 ext. 77422, laurie.zawertailo@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence of abstinence (time frame: 7 days post-target quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515354, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.