The FINANCIAL — A £2.4 million phase III trial delivered across 7 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 Awakn Life Sciences.
Building on positive results
According to UKRI, 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 which was also funded by MRC through the Developmental Pathway Funding Scheme 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, with the aim of rolling 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 will look at whether the ketamine and therapy package reduces harmful drinking.
Urgent need for new treatments
Trial lead 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 each year, and wider UK society around £40 billion according to UKRI
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.
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.
Increased treatment options
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:
Ketamine assisted psychotherapy for people with alcohol dependence offers the chance for a paradigm shift in how we treat this challenging and frequently re-occurring problem.
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.
Ultimately, this study should lead to increased treatment options and improved outcomes for people with alcohol dependence, who at present have very few treatment options, when it comes to helping them stay sober or to develop a healthy relationship with alcohol after a detox.a