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No evidence for exosome treatment in reducing alcohol relapse – a failed confirmatory multi-center study

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dc.contributor.authorMeinhardt, Marcus
dc.contributor.authorHabelt, Bettina
dc.contributor.authorSkorodumov, Ivan
dc.contributor.authorSchwarz, Cindy
dc.contributor.authorBernhardt, Nadine
dc.contributor.authorWinter, Christine
dc.contributor.authorHardar, Ravit
dc.contributor.authorMüller, Christian
dc.contributor.authorIsrael, Yedy
dc.contributor.authorEzquer, Fernando
dc.contributor.authorSpanagel, Rainer
dc.date.accessioned2026-09-03T19:54:26Z
dc.date.available2026-09-03T19:54:26Z
dc.date.issued2025
dc.description.abstractPreclinical studies have suggested that intranasal administration of mesenchymal stem cell-derived exosomes can reduce alcohol intake and relapse-like behavior in rodents. To assess the translational potential of these findings, we conducted a preregistered, multi-center preclinical randomized controlled trial (preRCT) across several German research sites. Using the alcohol deprivation effect (ADE) model in both male and female Wistar rats, we evaluated whether exosome treatment attenuates relapse-like drinking behavior following repeated deprivation phases. Given the hurdles in standardizing exosome isolation, dosage, and intranasal delivery into the brain, we performed first a functional validation experiment of intranasally delivered exosomes. For providing such a functional proof, we conducted electrocorticography (ECoG) recording and showed that exosomes are capable of mitigating impaired electrophysiological activity in the prefrontal cortex in rats that underwent the ADE procedure. However, contrary to previously published positive findings, our confirmatory multi-site preRCT results did not demonstrate a significant reduction in ethanol consumption during an ADE in Wistar rats following exosome treatment. No sex or site-specific effects were observed. Given the absence of efficacy, the study was terminated early in alignment with the 3R principles of animal research ethics. These findings suggest that the previously reported benefits of exosome treatment may be model-specific and do not generalize to a broader genetic background or experimental model. Our results emphasize the necessity of replication across diverse preclinical models and rat lines prior to clinical translation and highlight the importance of publishing null results to improve transparency and reproducibility in addiction research.
dc.description.versionVersión Publicada
dc.identifier.citationMarcus W. Meinhardt, Bettina Habelt, Ivan Skorodumov, Cindy Schwarz, Nadine Bernhardt, Christine Winter, Ravit Hardar, Christian P. Müller, Yedy Israel, Fernando Ezquer, Rainer Spanagel. No evidence for exosome treatment in reducing alcohol relapse – a failed confirmatory multi-center study, Addiction Neuroscience, Volume 17, 2025, 100234, ISSN 2772-3925, https://doi.org/10.1016/j.addicn.2025.100234
dc.identifier.doihttps://doi.org/10.1016/j.addicn.2025.100234
dc.identifier.urihttps://hdl.handle.net/11447/11061
dc.language.isoen
dc.subjectExosomes
dc.subjectAlcohol relapse
dc.subjectMulti-center
dc.subjectAddiction reserach
dc.subjectReproducibility
dc.titleNo evidence for exosome treatment in reducing alcohol relapse – a failed confirmatory multi-center study
dc.typeArticle
dcterms.accessRightsAcceso Abierto
dcterms.sourceAddiction Neuroscience
dspace.entity.typePublication
relation.isAuthorOfPublicationc74766c7-dad8-4d11-b35d-01da0664f3da
relation.isAuthorOfPublication.latestForDiscoveryc74766c7-dad8-4d11-b35d-01da0664f3da

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