This double-blind, randomised, controlled trial (n=280) will investigate the efficacy of ketamine-assisted psychological therapy in severe alcohol use disorder (AUD) patients.
Conducted across up to 10 NHS sites in the UK, the study aims to assess whether KARE therapy, involving ketamine infusions combined with mindfulness-based relapse-prevention therapy, impacts alcohol use compared to a control condition receiving a lower dose of ketamine and alcohol education.
Participants, adults with severe AUD seeking long-term reduction or cessation of alcohol consumption, will undergo a series of infusions and therapy sessions over six months. The study will evaluate various outcomes including the number of heavy drinking days, relapse rates, social functioning, depression levels, and more, with follow-up assessments extending to 12 months post-randomisation.
Funded by the National Institute for Health Research (NIHR) and AWAKN Life Sciences, the trial runs from August 2023 to November 2026 under the University of Exeter’s oversight. The results are anticipated to be disseminated through peer-reviewed journals, conferences, and regulatory authorities, with data archived for future research purposes.
Trial Details
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Sponsors & Collaborators
Awakn Life SciencesAWAKN Life Sciences aims to bring psychedelics therapy to the UK. Under this company fall three arms; psychedelic research, clinic platform, and practitioner training.