The largest ever trial to investigate whether ketamine-assisted therapy could help people with alcohol problems stop drinking is now recruiting participants.
The first patients are now being screened to see if they are eligible to take part in the £2.4 million phase III trial is led by the University of Exeter. The trial will initially be delivered at eight NHS sites across the UK.
The study, called Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse (MORE-KARE), is co-funded by a partnership between the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC), and biotech company Awakn Life Sciences. It is managed by the Exeter Clinical Trials Unit.
The latest trial builds on positive initial findings of an earlier phase II trial, which showed combined ketamine and therapy treatment was safe and tolerable for people with severe alcohol use disorder. The previous trial found that participants who had ketamine combined with therapy went from drinking every day to remaining sober 86 per cent of the time over a six-month period
Now, the new trial, called MORE-KARE, will further test this finding, with the aim of rolling it out into the NHS if the combined treatment proves effective.
Trial lead Professor Celia Morgan, from the University of Exeter, said: "More than half a million UK adults have serious alcohol problems that require help, yet only one in five of those get treatment. Current treatments have low success rates – we know that three out of four people who quit alcohol will be back drinking heavily after a year. This new trial is helping to fill the gap in the urgent search for new treatments. We're excited that the NIHR and Awakn Life Sciences have funded this study, which is the largest study of ketamine combined with psychological therapy to take place anywhere in the world."
Early research conducted in the 1980s found promising reductions in alcohol relapse rates following ketamine treatment. More recent studies have also shown that ketamine has a fast-acting anti-depressant effect and may improve learning of new information - both of which may help prevent relapse in alcohol use disorder.
In a recent paper, the KARE team shed new light on why ketamine may be effective. A pilot study involved 28 people being given ketamine, or a placebo, combined with mindfulness therapy. They found that ketamine may improve treatment outcomes by making people more receptive to mindfulness therapy, increasing engagement with the therapy.
Associate Professor Rupert McShane, Consultant Psychiatrist at the University of Oxford and collaborator on the trial, said: "Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic. Alcohol-related harm is estimated to cost the NHS around £3.5 billion each year, and wider UK society around £40 billion. We urgently need new treatments. If this trial establishes that combined ketamine and therapy works, this will be a step closer towards seeing it used in the NHS, to help people turn their lives around."
Participants will be randomly allocated to receive a different dose of ketamine infusion, via a drip. They will also receive psychological support sessions with a trial therapist. The ketamine dose and type of psychological support received by each participant will be randomly assigned by a computer. Neither the participant nor the site research team will be told which dose/support they are given. To measure how effective the treatment is, alcohol use will be monitored via drink diaries and daily self-breathalysing. Participants will be followed up in person at three and six months. Recruitment is currently open in Exeter and Oxford, with more locations expected to open soon.
