Alcoholics will be offered ketamine to help them stay off the booze for longer in a new medical trial led by the University of Exeter. The £2.4 million trial, now in its third phase, will be delivered to 280 people with severe alcohol use disorder across seven NHS sites before determining whether to make it accessible to the wider public.
The latest trial builds on a positive result of an earlier phase II trial, designed to test whether the Ketamine-led treatment is safe. The earlier stages showed positive findings and that ketamine and therapy treatment was tolerable for people with severe alcohol use disorder. It also found that participants who had ketamine combined with therapy stayed completely sober, with 86 per cent of participants abstinent in the six-month follow-up.
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.”
Now, the Ketamine for Reduction of Alcohol Relapse (KARE) trial will move to the next step of drug development, a phase III trial. Half of the participants 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.
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 new trial will recruit participants across the following organisations: Imperial College London; Oxford Health NHS Trust; Greater Manchester Mental Health NHS Trust; Northern, Eastern, and Western Devon CCG; South London and Maudsley NHS Foundation Trust; the Exeter Clinical Trials Unit; Mersey Care NHS Trust; University College London Hospitals NHS Foundation Trust; NHS Forth Valley; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust. Recruitment will commence mid-way through 2023.