Correcting misclassification of overdose events in a randomised trial comparing buprenorphine and naltrexone for opioid dependence
Public Deposited- Creator
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Dasgupta, Nabarun
- Affiliation: Injury Prevention Research Center
- Other Affiliation: Gillings School of Global Public Health
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Ajazi, Elizabeth M.
- Affiliation: Gillings School of Global Public Health
- Other Affiliation: University of Pennsylvania
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Schwartz, Todd A.
- Affiliation: Gillings School of Global Public Health
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Marshall, Stephen W.
- Affiliation: Injury Prevention Research Center
- Other Affiliation: Gillings School of Global Public Health
- Abstract
- MANUSCRIPT UNDER REVIEW. The X:BOT study (CTN-0051) is an influential randomized trial comparing safety and efficacy of buprenorphine and naltrexone to treat opioid dependence. The original publication reported no statistically significant difference in the safety endpoint of overdose. We reanalysed the trial using the public dataset and replicated most findings. However, we identified six additional overdose events that the original analysis missed. Five of these additional events were in the naltrexone arm, and one in the buprenorphine arm. Assuming similar efficacy, inclusion of these originally misclassified cases fundamentally alters clinical risk-benefit: 19/283 participants experienced overdoses in the naltrexone arm, compared to 9/287 for buprenorphine. In addition to correcting the misclassification, our reanalysis accounted for timing of safety outcomes. The hazard ratio for overdose in the naltrexone arm, relative to buprenorphine, becomes 2.40 (95% CI 1.09, 5.30; p=0.03) with misclassification corrected.
- Date of publication
- February 25, 2022
- DOI
- Resource type
- Article
- Rights statement
- In Copyright
- Language
- English
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