A £2.4 MILLION phase III trial delivered across seven NHS sites will investigate whether ketamine-assisted therapy could help alcoholics stay off alcohol for longer.
Led by the University of Exeter, the new trial is being funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR) through their Efficacy and Mechanism Evaluation (EME) Programme, with additional support from Awaken 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 earlier study that MRC also funded found that participants who had ketamine combined with therapy stayed completely sober. This represented 86% abstinence in the 6-month follow-up.
Now, the Ketamine for Reduction of Alcohol Relapse trial will move to the next step of drug development, a phase III trial. It will test this promising finding further to roll it out into the NHS if it proves effective.
The trial will be run in conjunction with the NHS, and the treatment will be provided in 7 NHS sites across the UK.
The trial will recruit 280 people with severe alcohol use disorder, and participants will be randomly allocated to 2 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 7-session education package about the harmful effects of alcohol.
Researchers examine if the ketamine plus therapy package reduces harmful drinking.
Trial leader Professor Celia Morgan, from the University of Exeter, said: “More than 2 million UK adults have serious alcohol problems, yet only 1 in 5 of those get treatment. 3 out of 4 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 yearly, 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 plus therapy works, we hope we can begin to see it used in NHS settings.
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: “We desperately 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.”