A new £2.4 million phase III trial is set to investigate whether ketamine-assisted therapy could help alcoholics stay off alcohol for longer.
The trial, delivered across seven NHS sites across the UK, is being led by the University of Exeter and funded by the National Institute for Health and Care Research (NIHR).
Awakn Life Sciences, a biotech company researching and developing psychedelic therapeutics to treat addiction, will provide additional funding.
Professor Anne Lingford-Hughes, Professor of Addiction Biology at Imperial College London and Consultant Addiction Psychiatrist at Central North West London NHS Foundation Trust, said:
“This is the largest trial of its kind in the world and builds on our earlier, smaller positive trial.
“We currently have few effective treatment options for people with alcoholism, and not all of these work for everyone.
“We desperately therefore need new treatments using different approaches such as this trial to help people regain control of their life and reduce the immense harms they experience from alcohol.”
The latest trial builds on a positive result of an earlier phase II trial, which showed ketamine and therapy treatment was safe and tolerable for people with severe alcohol use disorder.
Participants in the earlier study 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, with the aim of rolling it out into the NHS if the drug proves effective.
A total 280 people with severe alcohol use disorder will be recruited for the trial and participants will be randomly allocated to two arms.
Half of the participants will be given ketamine at the dose used in the first clinical trial with psychological therapy.
The other participants will be given a very low dose of ketamine and a seven-session education package about the harmful effects of alcohol.
The trial will reveal whether the ketamine and therapy package reduces harmful drinking.
Dr Stephen Kaar, one of the study leads of the University of Manchester, and Consultant Addictions Psychiatrist at Greater Manchester Mental Health NHS Foundation Trust, said:
“By bringing together the specific biochemical effects of ketamine and the supportive, structured and change focused space of psychotherapy, this study should finally establish the usefulness of this approach to treating addictions.”
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.”
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