Ketamine-assisted psychological therapy to reduce alcohol relapse

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.

Topic Alcohol Use Disorder Addiction
Compound Placebo Ketamine
Country United Kingdom
Visit trial
Status Not yet recruiting
Results Published No
Start date 30 August 2023
End date 30 November 2026
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 280
Sex All
Age 18- 99
Therapy Yes

Trial Details

This trial (n=280) investigates the effectiveness of ketamine-assisted therapy in severe alcohol use disorder patients. Administered at NHS sites across the UK, the study assesses if KARE therapy reduces alcohol consumption compared to standard treatment. Funded by NIHR and AWAKN Life Sciences, it runs from August 2023 to November 2026, aiming to improve AUD treatment outcomes.

NCT Number ISRCTN85955128

Sponsors & Collaborators

Awakn Life Sciences
AWAKN Life Sciences aims to bring psychedelics therapy to the UK. Under this company fall three arms; psychedelic research, clinic platform, and practitioner training.

Data attribution

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