Published: 12 August 2024
The largest ever trial to investigate whether ketamine-assisted therapy could help people with alcohol problems stop drinking is now recruiting participants.
The study is called Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse (MORE-KARE). It is funded by a partnership between NIHR and the Medical Research Council (MRC).
Additional funding comes from biotech company Awakn Life Sciences. The study is managed by the Exeter Clinical Trials Unit.
The first patients are now being screened to see if they are eligible to take part. The phase III trial is led by the University of Exeter. The trial will initially be delivered at 8 NHS sites across the UK.
Positive initial findings
The latest trial builds on positive initial findings of an earlier phase II trial. The second phase showed combined ketamine and therapy treatment was safe and tolerable for people with severe alcohol use disorder. It found participants who had ketamine combined with therapy went from drinking daily to remaining sober 86% of the time. This was over a 6-month period.
The latest phase will further test this finding. The aim is to roll out the combined treatment in the NHS if it 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 have funded this study, which is the largest study of ketamine combined with psychological therapy to take place anywhere in the world.”
In the 1980s, researchers found promising reductions in alcohol relapse rates following ketamine treatment. More recent studies have also shown ketamine has a fast-acting antidepressant effect. It may also improve learning of new information. Both of these findings 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 ketamine may improve treatment outcomes by making people more receptive to mindfulness therapy, increasing engagement.
Random allocation, psychological support
Participants will be randomly allocated into two arms of the trial. Each will 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. This will be done via drink diaries and daily self-breathalysing. Participants will be followed up in person at 3 and 6 months. Recruitment is currently open in Exeter and Oxford. More locations are expected to open soon.
The MORE-KARE study is funded by the Efficacy and Mechanism Evaluation (EME) Programme. The EME Programme is a partnership between NIHR and MRC. For more information, please visit the MORE-KARE study page.