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£2.4million to fund largest-ever trial of ketamine-assisted therapy for alcohol disorder

Published: 19 December 2022

A new trial will investigate whether ketamine-assisted therapy could help alcoholics stay off alcohol for longer. 

The £2.4 million trial is led by the University of Exeter and will be delivered at seven NHS sites across the UK. 

It is being funded by a Medical Research Council (MRC) and NIHR partnership, with more funding from biotech company Awakn Life Sciences. 

The latest trial builds on a positive result of an earlier phase II trial, designed to test whether the treatment is safe. It showed ketamine and therapy treatment was safe and tolerable for people with severe alcohol use disorder. The phase II trial found that participants who had ketamine combined with therapy stayed completely sober. Representing 86 per cent abstinence in the six month follow-up. Now, the Ketamine for Reduction of Alcohol Relapse (KARE) trial will move to the next step of drug development, a phase III trial. It will test this promising finding further, with the aim of rolling it out into the NHS if it proves effective.

The trial will enrol 280 people with severe alcohol use disorder, who will be randomly allocated into two arms. Half will be given ketamine at the dose used in the first clinical trial with psychological therapy. The other half will be given a very low dose of ketamine and a seven-session education package about the harmful effects of alcohol. Researchers will look at whether the ketamine and therapy package reduces harmful drinking.

Trial lead Professor Celia Morgan, from the University of Exeter, said: “More than two million UK adults have serious alcohol problems, yet only one in five of those get treatment. Three out of four people who quit alcohol will be back drinking heavily after a year. Alcohol-related harm is estimated to cost the NHS around £3.5 billion each year, and wider UK society around £40 billion. 

“Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic. We urgently need new treatments. If this trial establishes that ketamine and therapy works, we hope we can begin to see it used in NHS settings.” 

Awakn CEO Anthony Tennyson added “For this phase III to have the support and funding from the NIHR and for it to be delivered in the NHS is a great endorsement of this treatment’s potential and a sign of how badly a new more effective treatment is needed to help the millions of people suffering from Alcohol addiction in the UK. We are very proud to be part of this important piece of work.

More information about the study is available on the NIHR Funding & Awards Website.

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