Saki Rubaiya Talukder , Julia Lappin , Veronica Clare Boland , Natasha Weaver , Hayden McRobbie , Ryan James Courtney
{"title":"有精神障碍和无精神障碍吸烟者服用胞二磷胆碱和伐尼克兰后出现的与精神健康相关的不良事件：随机对照试验的二次分析","authors":"Saki Rubaiya Talukder , Julia Lappin , Veronica Clare Boland , Natasha Weaver , Hayden McRobbie , Ryan James Courtney","doi":"10.1016/j.addbeh.2024.108148","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs.</p></div><div><h3>Methods</h3><p>Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose.</p></div><div><h3>Results</h3><p>Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94).</p></div><div><h3>Conclusion</h3><p>Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. However, larger clinical trials focused on MH-related AEs are needed for more conclusive evidence.</p></div>","PeriodicalId":7155,"journal":{"name":"Addictive behaviors","volume":"159 ","pages":"Article 108148"},"PeriodicalIF":3.7000,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0306460324001977/pdfft?md5=e9a117521df203fd1e73846973d21383&pid=1-s2.0-S0306460324001977-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Mental health related adverse events of cytisine and varenicline in smokers with and without mental health disorders: Secondary analysis of a randomized controlled trial\",\"authors\":\"Saki Rubaiya Talukder , Julia Lappin , Veronica Clare Boland , Natasha Weaver , Hayden McRobbie , Ryan James Courtney\",\"doi\":\"10.1016/j.addbeh.2024.108148\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs.</p></div><div><h3>Methods</h3><p>Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose.</p></div><div><h3>Results</h3><p>Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94).</p></div><div><h3>Conclusion</h3><p>Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. 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Mental health related adverse events of cytisine and varenicline in smokers with and without mental health disorders: Secondary analysis of a randomized controlled trial
Introduction
Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs.
Methods
Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose.
Results
Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94).
Conclusion
Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. However, larger clinical trials focused on MH-related AEs are needed for more conclusive evidence.
期刊介绍：
Addictive Behaviors is an international peer-reviewed journal publishing high quality human research on addictive behaviors and disorders since 1975. The journal accepts submissions of full-length papers and short communications on substance-related addictions such as the abuse of alcohol, drugs and nicotine, and behavioral addictions involving gambling and technology. We primarily publish behavioral and psychosocial research but our articles span the fields of psychology, sociology, psychiatry, epidemiology, social policy, medicine, pharmacology and neuroscience. While theoretical orientations are diverse, the emphasis of the journal is primarily empirical. That is, sound experimental design combined with valid, reliable assessment and evaluation procedures are a requisite for acceptance. However, innovative and empirically oriented case studies that might encourage new lines of inquiry are accepted as well. Studies that clearly contribute to current knowledge of etiology, prevention, social policy or treatment are given priority. Scholarly commentaries on topical issues, systematic reviews, and mini reviews are encouraged. We especially welcome multimedia papers that incorporate video or audio components to better display methodology or findings.
Studies can also be submitted to Addictive Behaviors? companion title, the open access journal Addictive Behaviors Reports, which has a particular interest in ''non-traditional'', innovative and empirically-oriented research such as negative/null data papers, replication studies, case reports on novel treatments, and cross-cultural research.
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