Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial
Abstract Background Cigarette smoking is a leading cause of death and disease, including those related to the cardiovascular system. Cytisine is a plant-based medication, which works in a similar mechanism to varenicline. It is safe, efficacious, and cost-effective for smoking cessation. While there...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-01-01
|
| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-024-01591-4 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832571975741997056 |
|---|---|
| author | Hassan Mir Javad Heshmati Kerri-Anne Mullen Ashley Baldwin Evyanne Quirouette Andrew Pipe Robert Reid |
| author_facet | Hassan Mir Javad Heshmati Kerri-Anne Mullen Ashley Baldwin Evyanne Quirouette Andrew Pipe Robert Reid |
| author_sort | Hassan Mir |
| collection | DOAJ |
| description | Abstract Background Cigarette smoking is a leading cause of death and disease, including those related to the cardiovascular system. Cytisine is a plant-based medication, which works in a similar mechanism to varenicline. It is safe, efficacious, and cost-effective for smoking cessation. While there are effective therapies such as nicotine replacement therapy, bupropion, varenicline, and cytisine for smoking cessation, relapse remains common. It is unclear how best to support these individuals. This study aims to assess the feasibility of randomizing patients who relapse to combination NRT or cytisine after admission to a cardiac hospital. Study design Randomized, two-group parallel feasibility trial. Methods This trial will recruit relapsed smokers from the University of Ottawa Heart Institute. Participants will be randomized 1:1 to receive cytisine or combination NRT, alongside counseling and follow-up support. Feasibility outcomes include recruitment rates and treatment completion. Secondary outcomes include smoking cessation rates and adverse events. A total of 60 participants will be recruited using stratified randomization by sex to ensure gender balance. Data will be analyzed descriptively, focusing on feasibility and efficacy measures to inform future trials. Discussion The primary aim of this study is to evaluate the feasibility of recruiting patients who were recently admitted to the hospital and have relapsed to smoking within 180 days post-discharge. This will inform future studies aimed at recruiting patients who have relapsed to understand how best to support them to quit smoking. This study will also compare the acceptability, efficacy, and safety of cytisine compared to combination NRT, as demonstrated in previous studies in other populations. Notably, cytisine’s shorter regimen and natural composition broaden its appeal, potentially supporting a wider spectrum of people who smoke. The study’s robust design, infrastructure, and expertise enhance its feasibility. Future research avenues, especially among cardiac patients and relapsed individuals, promise further insights, potentially transforming cessation strategies worldwide. Trial registration Registered at Clinicaltrials.gov (CT04286295) on 14 March 2022. https://clinicaltrials.gov/study/NCT04286295?locStr=Canada&country=Canada&intr=Cytisine&rank=3 . |
| format | Article |
| id | doaj-art-078567f2da114cefad2506186bc45e71 |
| institution | Kabale University |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-078567f2da114cefad2506186bc45e712025-02-02T12:09:17ZengBMCPilot and Feasibility Studies2055-57842025-01-011111910.1186/s40814-024-01591-4Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trialHassan Mir0Javad Heshmati1Kerri-Anne Mullen2Ashley Baldwin3Evyanne Quirouette4Andrew Pipe5Robert Reid6University of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteUniversity of Ottawa Heart InstituteAbstract Background Cigarette smoking is a leading cause of death and disease, including those related to the cardiovascular system. Cytisine is a plant-based medication, which works in a similar mechanism to varenicline. It is safe, efficacious, and cost-effective for smoking cessation. While there are effective therapies such as nicotine replacement therapy, bupropion, varenicline, and cytisine for smoking cessation, relapse remains common. It is unclear how best to support these individuals. This study aims to assess the feasibility of randomizing patients who relapse to combination NRT or cytisine after admission to a cardiac hospital. Study design Randomized, two-group parallel feasibility trial. Methods This trial will recruit relapsed smokers from the University of Ottawa Heart Institute. Participants will be randomized 1:1 to receive cytisine or combination NRT, alongside counseling and follow-up support. Feasibility outcomes include recruitment rates and treatment completion. Secondary outcomes include smoking cessation rates and adverse events. A total of 60 participants will be recruited using stratified randomization by sex to ensure gender balance. Data will be analyzed descriptively, focusing on feasibility and efficacy measures to inform future trials. Discussion The primary aim of this study is to evaluate the feasibility of recruiting patients who were recently admitted to the hospital and have relapsed to smoking within 180 days post-discharge. This will inform future studies aimed at recruiting patients who have relapsed to understand how best to support them to quit smoking. This study will also compare the acceptability, efficacy, and safety of cytisine compared to combination NRT, as demonstrated in previous studies in other populations. Notably, cytisine’s shorter regimen and natural composition broaden its appeal, potentially supporting a wider spectrum of people who smoke. The study’s robust design, infrastructure, and expertise enhance its feasibility. Future research avenues, especially among cardiac patients and relapsed individuals, promise further insights, potentially transforming cessation strategies worldwide. Trial registration Registered at Clinicaltrials.gov (CT04286295) on 14 March 2022. https://clinicaltrials.gov/study/NCT04286295?locStr=Canada&country=Canada&intr=Cytisine&rank=3 .https://doi.org/10.1186/s40814-024-01591-4CytisineNicotine replacement therapyCardiovascular diseaseSmoking relapse |
| spellingShingle | Hassan Mir Javad Heshmati Kerri-Anne Mullen Ashley Baldwin Evyanne Quirouette Andrew Pipe Robert Reid Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial Pilot and Feasibility Studies Cytisine Nicotine replacement therapy Cardiovascular disease Smoking relapse |
| title | Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial |
| title_full | Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial |
| title_fullStr | Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial |
| title_full_unstemmed | Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial |
| title_short | Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial |
| title_sort | cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers protocol for a pilot randomized controlled trial |
| topic | Cytisine Nicotine replacement therapy Cardiovascular disease Smoking relapse |
| url | https://doi.org/10.1186/s40814-024-01591-4 |
| work_keys_str_mv | AT hassanmir cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT javadheshmati cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT kerriannemullen cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT ashleybaldwin cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT evyannequirouette cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT andrewpipe cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial AT robertreid cytisinecomparedtocombinationnicotinereplacementtherapytoreducecigaretteconsumptioninrelapsedsmokersprotocolforapilotrandomizedcontrolledtrial |