Open letter to Richard Horton (editor of The Lancet) regarding X:BOT Clinical Trial

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  • Ajazi, Elizabeth
    • Affiliation: Gillings School of Global Public Health
    • Other Affiliation: University of Pennsylvania
  • Dasgupta, Nabarun
Abstract
  • We write to express concerns regarding the statistical analysis in the X:BOT study published by Lee et al. (2018), and to request that The Lancet correct misstatements about overdose risk with extended-release naltrexone arising from a data error in the original article. Reanalysis of public trial data from NIH shows that the authors of the 2018 publication failed to include multiple overdoses in their comparison of buprenorphine and naltrexone for opioid dependence. This error resulted in the erroneous conclusion that buprenorphine and naltrexone have no difference in overdose risk: The overdose risk among subjects in the naltrexone arm was in fact 2.4 times higher than buprenorphine. The Lancet was notified in February 2022 of this data error but as of October the journal has not issued a Notice of Concern or retraction of the original article.
  • ----------- Text of scientific comment submitted to The Lancet, under review since February 2022. https://cdr.lib.unc.edu/concern/articles/bk128n316
  • ----------- Public Access Dataset: https://datashare.nida.nih.gov/study/nidactn0051 Replication Code and Jupyter Notebook: https://cdr.lib.unc.edu/downloads/bk128n33r?locale=en
  • ----------- Video: https://vimeo.com/761473878 of Podium/Oral presentation at ISPE's 38th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2022), August 25 at the Bella Center, Copenhagen, Denmark. Slides: https://cdr.lib.unc.edu/concern/scholarly_works/qz20t335q
  • ----------- Original X:BOT trial publication in The Lancet Lee JD, Nunes EV Jr, Novo P, Bachrach K, Bailey GL, Bhatt S, Farkas S, Fishman M, Gauthier P, Hodgkins CC, King J, Lindblad R, Liu D, Matthews AG, May J, Peavy KM, Ross S, Salazar D, Schkolnik P, Shmueli-Blumberg D, Stablein D, Subramaniam G, Rotrosen J. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018 Jan 27;391(10118):309-318. doi: 10.1016/S0140-6736(17)32812-X. Epub 2017 Nov 14. PMID: 29150198; PMCID: PMC5806119.
  • ----------- Our re-analysis published in peer-reviewed journal Ajazi EM, Dasgupta N, Marshall SW, Monaco J, Howard AG, Preisser JS, Schwartz TA. Revisiting the X:BOT Naltrexone Clinical Trial Using a Comprehensive Survival Analysis. J Addict Med. 2022 Jul-Aug 01;16(4):440-446. doi: 10.1097/ADM.0000000000000931. PMID: 35960214.
  • ----------- Original Authors' Response: Lee JD, Nunes EV, Novo P, May J, Matthews A, Van Veldhuisen P, Lindblad R, Liu D, Rotrosen J. Commentary on Ajazi et al (2021) Re-analysis of the X:BOT Trial. J Addict Med. 2022 Jul-Aug 01;16(4):382-385. doi: 10.1097/ADM.0000000000000930. PMID: 35960212; PMCID: PMC9375053.
  • ----------- Full Ajazi dissertation: https://cdr.lib.unc.edu/concern/dissertations/td96kb39m?locale=en
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