{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T17:57:04Z","timestamp":1759773424438,"version":"3.37.3"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T00:00:00Z","timestamp":1593388800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T00:00:00Z","timestamp":1593388800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000015","name":"Canadian Cancer Society Research Institute","doi-asserted-by":"publisher","award":["703187"],"award-info":[{"award-number":["703187"]}],"id":[{"id":"10.13039\/501100000015","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and in many cases, the amount of nicotine provided is much less than when a smoker is smoking their usual number of cigarettes. The proposed study will test if titrating the dose of the nicotine patch (up to 84\u2009mg) will improve quitting success compared to those receiving a 21-mg nicotine patch with increasing doses of placebo patch.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is a multicenter, pragmatic, two-arm, placebo-controlled, block randomized controlled trial. We will recruit participants who smoke at least 10 cigarettes daily and are interested in making a quit attempt. After 2\u2009weeks of usual treatment with a 21-mg patch, participants who fail to quit smoking (target <jats:italic>n<\/jats:italic>\u2009=\u2009400) will be randomized to receive escalating doses of a nicotine patch vs matching placebo patches for an additional 10\u2009weeks or up to a maximum dose of 84\u2009mg per day. Those who stop smoking during the first 2\u2009weeks of usual treatment will continue with 21\u2009mg patch treatment for 10\u2009weeks and will form an additional comparison arm. In addition to the medication, participants will receive brief behavioral counseling at each study visit. The primary outcome will be biochemically confirmed continuous abstinence from smoking during the last 4\u2009weeks of treatment (weeks 9 to 12).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings. Given the evidence that quitting smoking at any age diminishes the risk of tobacco-related morbidity and mortality, even small increases in absolute quit rates can have a substantial population-level impact on reducing smoking-related disease, mortality rates, and associated healthcare costs.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03000387\">NCT03000387<\/jats:ext-link>. Registered on 22 December 2016.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-020-04532-7","type":"journal-article","created":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T13:03:52Z","timestamp":1593435832000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Laurie","family":"Zawertailo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian S.","family":"Hendershot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel F.","family":"Tyndale","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Le Foll","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andriy V.","family":"Samokhvalov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin E.","family":"Thorpe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Pipe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert D.","family":"Reid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5401-2996","authenticated-orcid":false,"given":"Peter","family":"Selby","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,6,29]]},"reference":[{"key":"4532_CR1","volume-title":"Canadian Tobacco, Alcohol and Drugs Survey (CTADS): summary of results for 2017","author":"Government of Canada","year":"2019","unstructured":"Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): summary of results for 2017. 2019. https:\/\/www.canada.ca\/en\/health-canada\/services\/canadian-tobacco-alcohol-drugs-survey\/2017-summary.html. Accessed 19 May 2020."},{"issue":"6","key":"4532_CR2","doi-asserted-by":"publisher","first-page":"886","DOI":"10.15288\/jsad.2007.68.886","volume":"68","author":"J Rehm","year":"2007","unstructured":"Rehm J, Gnam W, Popova S, Baliunas D, Brochu S, Fischer B, et al. The costs of alcohol, illegal drugs, and tobacco in Canada, 2002. J Stud Alcohol Drugs. 2007;68(6):886\u201395.","journal-title":"J Stud Alcohol Drugs"},{"issue":"2","key":"4532_CR3","doi-asserted-by":"publisher","first-page":"569","DOI":"10.1007\/BF03391651","volume":"33","author":"P Jha","year":"2011","unstructured":"Jha P. Avoidable deaths from smoking: a global perspective. Public Health Rev. 2011;33(2):569\u2013600.","journal-title":"Public Health Rev"},{"issue":"1","key":"4532_CR4","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1177\/0269881112458731","volume":"27","author":"A McNeill","year":"2013","unstructured":"McNeill A, Munaf\u00f2 MR. Reducing harm from tobacco use. J Psychopharmacol. 2013;27(1):13\u20138.","journal-title":"J Psychopharmacol"},{"issue":"11","key":"4532_CR5","doi-asserted-by":"publisher","first-page":"1719","DOI":"10.1158\/1940-6207.CAPR-11-0453","volume":"4","author":"PG Shields","year":"2011","unstructured":"Shields PG. Long-term nicotine replacement therapy: cancer risk in context. Cancer Prev Res (Phila). 2011;4(11):1719\u201323.","journal-title":"Cancer Prev Res (Phila)"},{"unstructured":"Reid JL, Hammond D, Tariq U, Burkhalter R, Rynard VL, Douglas O. Tobacco use in Canada: patterns and trends. Waterloo: Propel Centre for Population Health Impact, University of Waterloo; 2019.","key":"4532_CR6"},{"issue":"1","key":"4532_CR7","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/1617-9625-8-8","volume":"8","author":"EJ Mills","year":"2010","unstructured":"Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010;8(1):8.","journal-title":"Tob Induc Dis"},{"issue":"7","key":"4532_CR8","doi-asserted-by":"publisher","first-page":"968","DOI":"10.1016\/j.amjcard.2012.05.028","volume":"110","author":"KJ Woolf","year":"2012","unstructured":"Woolf KJ, Zabad MN, Post JM, McNitt S, Williams GC, Bisognano JD. Effect of nicotine replacement therapy on cardiovascular outcomes after acute coronary syndromes. Am J Cardiol. 2012;110(7):968\u201370.","journal-title":"Am J Cardiol"},{"key":"4532_CR9","volume-title":"CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride) - revision to the consumer information of non-nicotine smoking cessation aids - for health professionals","author":"Health Canada","year":"2013","unstructured":"Health Canada. CHAMPIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride) - revision to the consumer information of non-nicotine smoking cessation aids - for health professionals. 2013. https:\/\/www.healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2013\/33621a-eng.php. Accessed 18 Aug 2014."},{"issue":"4","key":"4532_CR10","doi-asserted-by":"publisher","first-page":"506","DOI":"10.1111\/j.1360-0443.2007.01750.x","volume":"102","author":"R West","year":"2007","unstructured":"West R. The clinical significance of \u2018small\u2019effects of smoking cessation treatments. Addiction. 2007;102(4):506\u20139.","journal-title":"Addiction"},{"issue":"5","key":"4532_CR11","first-page":"CD000146","volume":"5","author":"J Hartmann-Boyce","year":"2018","unstructured":"Hartmann-Boyce J, Chepkin SC, Ye W, Bullen C, Lancaster T. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018;5(5):CD000146.","journal-title":"Cochrane Database Syst Rev"},{"issue":"3","key":"4532_CR12","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1111\/add.12429","volume":"109","author":"D Kotz","year":"2014","unstructured":"Kotz D, Brown J, West R. \u2018Real-world\u2019effectiveness of smoking cessation treatments: a population study. Addiction. 2014;109(3):491\u20139.","journal-title":"Addiction"},{"issue":"5","key":"4532_CR13","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1080\/09595230802245527","volume":"27","author":"RA Walsh","year":"2008","unstructured":"Walsh RA. Over-the-counter nicotine replacement therapy: a methodological review of the evidence supporting its effectiveness. Drug Alcohol Rev. 2008;27(5):529\u201347.","journal-title":"Drug Alcohol Rev"},{"issue":"3","key":"4532_CR14","first-page":"958","volume":"287","author":"NL Benowitz","year":"1998","unstructured":"Benowitz NL, Zevin S, Jacob P. Suppression of nicotine intake during ad libitum cigarette smoking by high-dose transdermal nicotine. J Pharmacol Exp Ther. 1998;287(3):958\u201362.","journal-title":"J Pharmacol Exp Ther"},{"issue":"17","key":"4532_CR15","doi-asserted-by":"publisher","first-page":"1353","DOI":"10.1001\/jama.1995.03530170033028","volume":"274","author":"LC Dale","year":"1995","unstructured":"Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR. High-dose nicotine patch therapy: percentage of replacement and smoking cessation. JAMA. 1995;274(17):1353\u20138.","journal-title":"JAMA"},{"issue":"4","key":"4532_CR16","first-page":"CD013308","volume":"4","author":"N Lindson","year":"2019","unstructured":"Lindson N, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2019;4(4):CD013308.","journal-title":"Cochrane Database Syst Rev"},{"issue":"7\u20138","key":"4532_CR17","doi-asserted-by":"publisher","first-page":"247","DOI":"10.2119\/molmed.2009.00159","volume":"16","author":"JE Rose","year":"2010","unstructured":"Rose JE, Behm FM, Drgon T, Johnson C, Uhl GR. Personalized smoking cessation: interactions between nicotine dose, dependence and quit-success genotype score. Mol Med. 2010;16(7\u20138):247\u201353.","journal-title":"Mol Med"},{"issue":"3","key":"4532_CR18","first-page":"1608","volume":"282","author":"ES Messina","year":"1997","unstructured":"Messina ES, Tyndale RF, Sellers EM. A major role for CYP2A6 in nicotine C-oxidation by human liver microsomes. J Pharmacol Exp Ther. 1997;282(3):1608\u201314.","journal-title":"J Pharmacol Exp Ther"},{"issue":"1","key":"4532_CR19","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1038\/clpt.1993.117","volume":"54","author":"RD Hurt","year":"1993","unstructured":"Hurt RD, Dale LC, Offord KP, Lauger GG, Baskin LB, Lawson GM, et al. Serum nicotine and cotinine levels during nicotine-patch therapy. Clin Pharmacol Ther. 1993;54(1):98\u2013106.","journal-title":"Clin Pharmacol Ther"},{"issue":"5","key":"4532_CR20","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1038\/clpt.2010.3","volume":"87","author":"C Lerman","year":"2010","unstructured":"Lerman C, Jepson C, Wileyto E, Patterson F, Schnoll R, Mroziewicz M, et al. Genetic variation in nicotine metabolism predicts the efficacy of extended-duration transdermal nicotine therapy. Clin Pharmacol Ther. 2010;87(5):553\u20137.","journal-title":"Clin Pharmacol Ther"},{"issue":"2","key":"4532_CR21","doi-asserted-by":"publisher","first-page":"348","DOI":"10.1093\/ntr\/nts129","volume":"15","author":"RA Schnoll","year":"2012","unstructured":"Schnoll RA, Wileyto EP, Leone FT, Tyndale RF, Benowitz NL. High dose transdermal nicotine for fast metabolizers of nicotine: a proof of concept placebo-controlled trial. Nicotine Tob Res. 2012;15(2):348\u201354.","journal-title":"Nicotine Tob Res"},{"issue":"3","key":"4532_CR22","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1007\/s00213-010-2069-3","volume":"214","author":"N Lindson","year":"2011","unstructured":"Lindson N, Aveyard P. An updated meta-analysis of nicotine preloading for smoking cessation: investigating mediators of the effect. Psychopharmacology. 2011;214(3):579\u201392.","journal-title":"Psychopharmacology"},{"issue":"5","key":"4532_CR23","doi-asserted-by":"publisher","first-page":"667","DOI":"10.1097\/JCP.0b013e31829a829d","volume":"33","author":"P Selby","year":"2013","unstructured":"Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013;33(5):667\u201374.","journal-title":"J Clin Psychopharmacol"},{"issue":"3","key":"4532_CR24","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1007\/s002130000382","volume":"149","author":"R West","year":"2000","unstructured":"West R, Hajek P, Foulds J, Nilsson F, May S, Meadows A. A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler. Psychopharmacology. 2000;149(3):198\u2013202.","journal-title":"Psychopharmacology"},{"issue":"2","key":"4532_CR25","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1016\/S2213-2600(14)70294-2","volume":"3","author":"C Lerman","year":"2015","unstructured":"Lerman C, Schnoll RA, Hawk LW Jr, Cinciripini P, George TP, Wileyto EP, et al. Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2015;3(2):131\u20138.","journal-title":"Lancet Respir Med"},{"issue":"4","key":"4532_CR26","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1016\/0306-4603(82)90005-3","volume":"7","author":"HA Skinner","year":"1982","unstructured":"Skinner HA. The drug abuse screening test. Addict Behav. 1982;7(4):363\u201371.","journal-title":"Addict Behav"},{"key":"4532_CR27","volume-title":"Manual for the Depression Anxiety & Stress Scales","author":"PF Lovibond","year":"1995","unstructured":"Lovibond PF, Lovibond SH. Manual for the Depression Anxiety & Stress Scales. 2nd ed. Sydney: Psychology Foundation; 1995.","edition":"2"},{"doi-asserted-by":"crossref","unstructured":"Heatherton TF, Kozlowski LT, Frecker RC, Karl-Olov F. The Fagerstr\u00f6m test for nicotine dependence: a revision of the Fagerstr\u00f6m tolerance questionnaire. Br J Addict. 1991;86(9):1119\u201327.","key":"4532_CR28","DOI":"10.1111\/j.1360-0443.1991.tb01879.x"},{"issue":"6","key":"4532_CR29","doi-asserted-by":"publisher","first-page":"791","DOI":"10.1111\/j.1360-0443.1993.tb02093.x","volume":"88","author":"JB Saunders","year":"1993","unstructured":"Saunders JB, Aasland OG, Babor TF, De la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption-II. Addiction. 1993;88(6):791\u2013804.","journal-title":"Addiction"},{"key":"4532_CR30","first-page":"476","volume":"30","author":"JE Ware","year":"1992","unstructured":"Ware JE. A 36-item short-form health survey (SF-36), I: conceptual framework and item selection. Med Care. 1992;30:476\u201383.","journal-title":"Med Care"},{"issue":"1","key":"4532_CR31","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1097\/00005650-199401000-00004","volume":"32","author":"CA McHorney","year":"1994","unstructured":"McHorney CA, Ware JE Jr, Lu JR, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32(1):40\u201366.","journal-title":"Med Care"},{"issue":"1","key":"4532_CR32","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1080\/14622200020032051","volume":"3","author":"LS Cox","year":"2001","unstructured":"Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001;3(1):7\u201316.","journal-title":"Nicotine Tob Res"},{"issue":"11","key":"4532_CR33","doi-asserted-by":"publisher","first-page":"1467","DOI":"10.1111\/j.1360-0443.1991.tb01732.x","volume":"86","author":"ST Tiffany","year":"1991","unstructured":"Tiffany ST, Drobes DJ. The development and initial validation of a questionnaire on smoking urges. Br J Addict. 1991;86(11):1467\u201376.","journal-title":"Br J Addict"},{"issue":"9","key":"4532_CR34","doi-asserted-by":"publisher","first-page":"606","DOI":"10.1046\/j.1525-1497.2001.016009606.x","volume":"16","author":"K Kroenke","year":"2001","unstructured":"Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606\u201313.","journal-title":"J Gen Intern Med"},{"issue":"3","key":"4532_CR35","doi-asserted-by":"publisher","first-page":"289","DOI":"10.1001\/archpsyc.1986.01800030107013","volume":"43","author":"JR Hughes","year":"1986","unstructured":"Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986;43(3):289\u201394.","journal-title":"Arch Gen Psychiatry"},{"issue":"5","key":"4532_CR36","doi-asserted-by":"publisher","first-page":"912","DOI":"10.1016\/j.addbeh.2006.06.028","volume":"32","author":"JC Cappelleri","year":"2007","unstructured":"Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007;32(5):912\u201323.","journal-title":"Addict Behav"},{"issue":"9","key":"4532_CR37","doi-asserted-by":"publisher","first-page":"1460","DOI":"10.1093\/clinchem\/48.9.1460","volume":"48","author":"TP Moyer","year":"2002","unstructured":"Moyer TP, Charlson JR, Enger RJ, Dale LC, Ebbert JO, Schroeder DR, et al. Simultaneous analysis of nicotine, nicotine metabolites, and tobacco alkaloids in serum or urine by tandem mass spectrometry, with clinically relevant metabolic profiles. Clin Chem. 2002;48(9):1460\u201371.","journal-title":"Clin Chem"},{"issue":"12","key":"4532_CR38","first-page":"1668","volume":"11","author":"P Jacob 3rd","year":"2002","unstructured":"Jacob P 3rd, Hatsukami D, Severson H, Hall S, Yu L, Benowitz NL. Anabasine and anatabine as biomarkers for tobacco use during nicotine replacement therapy. Cancer Epidemiol Biomark Prev. 2002;11(12):1668\u201373.","journal-title":"Cancer Epidemiol Biomark Prev"},{"issue":"1","key":"4532_CR39","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1080\/1462220031000070552","volume":"5","author":"JR Hughes","year":"2003","unstructured":"Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003;5(1):13\u201325.","journal-title":"Nicotine Tob Res"},{"issue":"10","key":"4532_CR40","first-page":"1339","volume":"165","author":"VM Montori","year":"2001","unstructured":"Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ. 2001;165(10):1339\u201341.","journal-title":"CMAJ"},{"key":"4532_CR41","first-page":"CD000146","volume":"11","author":"LF Stead","year":"2012","unstructured":"Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD000146.","journal-title":"Cochrane Database Syst Rev"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04532-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-020-04532-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04532-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,29]],"date-time":"2021-06-29T00:23:32Z","timestamp":1624926212000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04532-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,29]]},"references-count":41,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4532"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04532-7","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2020,6,29]]},"assertion":[{"value":"25 May 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 June 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 June 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study protocol was approved by the Research Ethics Board at the Centre for Addiction and Mental Health (#039-2015). Written, informed consent will be obtained from all participants by research staff who have no clinical relationship with the patient. The study has also been approved by Health Canada Natural Products Directorate Clinical Trials Application (File number: HC6-24-c200364).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"LZ has received funding that includes salary support from Pfizer Inc. (GRAND Award) and the Health Services Research Fund from the Ontario Ministry of Health. PS declares that Johnson & Johnson, Novartis, and Pfizer Inc. are vendors of record for having provided free\/discounted smoking cessation pharmacotherapy for other research studies unrelated to this study. RFT has consulted for Ethismos and Quinn Emanuel. BLF has obtained funding from Pfizer Inc. (GRAND Awards, including salary support) for investigator-initiated projects and has received a coil for TMS smoking cessation study from Brainsway. Other funding sources are not related to smoking studies. All other authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"592"}}