The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial
Introduction Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may...
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BMJ Publishing Group
2020-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/10/e038184.full |
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| author | Michael J Abramson Billie Bonevski Rukshar Kaizerali Gobarani Gregory R Weeks Michael J Dooley Brian J Smith Antony Veale Ashley Webb Sue Kirsa Dennis Thomas Alistair Miller Rudi Gasser Eldho Paul Jacqueline Parkinson Darshana Meanger Lisa Coward Zoe Kopsaftis Olivia Rofe Paula Lee Johnson George |
| author_facet | Michael J Abramson Billie Bonevski Rukshar Kaizerali Gobarani Gregory R Weeks Michael J Dooley Brian J Smith Antony Veale Ashley Webb Sue Kirsa Dennis Thomas Alistair Miller Rudi Gasser Eldho Paul Jacqueline Parkinson Darshana Meanger Lisa Coward Zoe Kopsaftis Olivia Rofe Paula Lee Johnson George |
| author_sort | Michael J Abramson |
| collection | DOAJ |
| description | Introduction Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.Aims To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.Methods and analysis This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.Ethics and dissemination The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.Trial registration number Australia New Zealand Clinical Trials Registry (ACTRN12618001792213). |
| format | Article |
| id | doaj-art-8a9185db5f654668a360cf6e778641be |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8a9185db5f654668a360cf6e778641be2024-11-25T04:30:09ZengBMJ Publishing GroupBMJ Open2044-60552020-10-01101010.1136/bmjopen-2020-038184The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trialMichael J Abramson0Billie Bonevski1Rukshar Kaizerali Gobarani2Gregory R Weeks3Michael J Dooley4Brian J Smith5Antony Veale6Ashley Webb7Sue Kirsa8Dennis Thomas9Alistair Miller10Rudi Gasser11Eldho Paul12Jacqueline Parkinson13Darshana Meanger14Lisa Coward15Zoe Kopsaftis16Olivia Rofe17Paula Lee18Johnson George19School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, AustraliaFlinders Health and Medical Research Institute, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaPharmacy Department, Barwon Health, Geelong, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaGeneral and Respiratory Medicine, Bendigo Health, Bendigo, Victoria, AustraliaDepartment of Respiratory Medicine, Queen Elizabeth Hospital, Woodville South, South Australia, AustraliaDepartment of Anaesthesia and Pain Management, Frankston Hospital, Frankston, Victoria, AustraliaPharmacy Department, Monash Health, Clayton, Victoria, AustraliaPriority Research Centre for Healthy Lungs, The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, AustraliaRespiratory and Sleep Medicine, Royal Melbourne Hospital, Melbourne, Victoria, AustraliaDepartment of General Medicine, Barwon Health, Geelong, Victoria, AustraliaMonash University, Melbourne, Victoria, AustraliaPharmacy Department, Monash Health, Clayton, Victoria, AustraliaPharmacy Department, Frankston Hospital, Frankston, Victoria, AustraliaDepartment of Anaesthesia, Frankston Hospital, Frankston, Victoria, AustraliaRespiratory Medicine and Clinical Practice Unit, The Queen Elizabeth Hospital, Woodville South, South Australia, AustraliaPharmacy Department, Eastern Health Foundation, Box Hill, Victoria, AustraliaPharmacy Department, Eastern Health Foundation, Box Hill, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaIntroduction Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.Aims To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.Methods and analysis This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.Ethics and dissemination The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.Trial registration number Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).https://bmjopen.bmj.com/content/10/10/e038184.full |
| spellingShingle | Michael J Abramson Billie Bonevski Rukshar Kaizerali Gobarani Gregory R Weeks Michael J Dooley Brian J Smith Antony Veale Ashley Webb Sue Kirsa Dennis Thomas Alistair Miller Rudi Gasser Eldho Paul Jacqueline Parkinson Darshana Meanger Lisa Coward Zoe Kopsaftis Olivia Rofe Paula Lee Johnson George The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial BMJ Open |
| title | The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial |
| title_full | The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial |
| title_fullStr | The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial |
| title_full_unstemmed | The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial |
| title_short | The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial |
| title_sort | efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers vanish study protocol for a randomised placebo controlled trial |
| url | https://bmjopen.bmj.com/content/10/10/e038184.full |
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