The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Electronic Nicotine Delivery Systems*; Mental Disorders/*therapy ; Smoking Cessation/*methods ; Substance-Related Disorders/*therapy ; Varenicline/*therapeutic use; Adult ; Combined Modality Therapy ; Female ; Humans ; Male ; Mental Disorders/epidemiology ; Motivation ; New Zealand/epidemiology ; Smoking/epidemiology ; Smoking/psychology ; Smoking Cessation/psychology ; Substance-Related Disorders/epidemiology ; Treatment Outcome ; Varenicline/adverse effects

Background: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions.
Methods: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups.
Discussion: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates.
Trial Registration: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Tob Control. 2014 Nov;23(e2):e147-53. (PMID: 24727731)
Addict Behav. 2013 Oct;38(10):2529-31. (PMID: 23773961)
Drugs. 2010 Apr 16;70(6):643-50. (PMID: 20394453)
BMC Med. 2013 May 29;11:140. (PMID: 23718718)
BMC Public Health. 2009 Jun 18;9:194. (PMID: 19538719)
JAMA. 2014 Jan 8;311(2):145-54. (PMID: 24399553)
Cochrane Database Syst Rev. 2016 Sep 14;9:CD010216. (PMID: 27622384)
JAMA. 2014 Jan 8;311(2):155-63. (PMID: 24399554)
Am J Prev Med. 2016 Dec;51(6):1060-1071. (PMID: 27617367)
Int J Methods Psychiatr Res. 2010 Jun;19 Suppl 1:4-22. (PMID: 20527002)
Tob Induc Dis. 2015 Mar 24;13(1):5. (PMID: 25814920)
J Dual Diagn. 2012;8(2):117-125. (PMID: 22888309)
Addiction. 2016 Feb;111(2):220-30. (PMID: 26392127)
Health Econ. 2003 Jul;12(7):529-44. (PMID: 12825206)
Am J Psychiatry. 2014 Nov 1;171(11):1199-205. (PMID: 24934962)
Ann Intern Med. 2013 Sep 17;159(6):390-400. (PMID: 24042367)
J Biomed Inform. 2009 Apr;42(2):377-81. (PMID: 18929686)
J Clin Psychiatry. 2014 Jul;75(7):765-72. (PMID: 25006684)
Lancet. 2015 Sep 26;386(10000):1237. (PMID: 26338257)
Am J Psychiatry. 2013 Aug;170(8):860-7. (PMID: 23640009)
Lancet. 2013 Nov 16;382(9905):1629-37. (PMID: 24029165)
Nicotine Tob Res. 2012 Jan;14(1):75-8. (PMID: 22025545)
Addict Behav. 2007 May;32(5):912-23. (PMID: 16875787)
Am J Psychiatry. 2013 Dec;170(12):1460-7. (PMID: 24030388)
Addiction. 2005 Apr;100 Suppl 2:59-69. (PMID: 15755262)
Nicotine Tob Res. 2013 May;15(5):978-82. (PMID: 22990219)
Addiction. 2014 Nov;109(11):1801-10. (PMID: 25078252)
Drug Alcohol Depend. 2007 May;88 Suppl 2:S24-30. (PMID: 17056207)
Shanghai Arch Psychiatry. 2014 Dec;26(6):376-83. (PMID: 25642116)
JAMA. 2014 Jan 8;311(2):172-82. (PMID: 24399556)
Br J Addict. 1991 Sep;86(9):1119-27. (PMID: 1932883)
Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. (PMID: 15179542)
Arch Intern Med. 2011 Apr 25;171(8):770-7. (PMID: 21518946)
Lancet. 2016 Jun 18;387(10037):2507-20. (PMID: 27116918)
JAMA. 2014 Jul;312(2):155-61. (PMID: 25005652)
Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):949-53. (PMID: 20602347)
Annu Rev Clin Psychol. 2012;8:21-48. (PMID: 22224838)
Annu Rev Med. 2008;59:443-53. (PMID: 17914924)
Addiction. 2009 May;104(5):719-33. (PMID: 19413788)
JAMA. 2000 Oct 4;284(13):1689-95. (PMID: 11015800)
BMJ. 2015 Sep 21;351:h4065. (PMID: 26391240)
Eur Arch Psychiatry Clin Neurosci. 2015 Apr;265(3):259-68. (PMID: 25283510)
BMJ. 2015 May 08;350:h2147. (PMID: 25956159)
Addiction. 2013 Jul;108(7):1336-43. (PMID: 23445269)

16/066 International Health Research Council of New Zealand

Keywords: Addiction; E-cigarettes; Effectiveness; Electronic cigarettes; Mental illness; Randomised trial; Safety; Smoking cessation; Varenicline

W6HS99O8ZO (Varenicline)

Date Created: 20180506 Date Completed: 20190320 Latest Revision: 20240314

20240314

PMC5935940

10.1186/s12889-018-5351-7

29728074