The largest ever trial investigating whether Ketamine-Assisted Psychotherapy can help people with alcohol addiction, carried out in partnership between the NIHR (the UK's National Institute for Health and Care Research) and the Medical Research Council, and led by the University of Exeter, is currently recruiting participants.
August 12th, 2024
The largest trial ever to investigate whether Ketamine-Assisted Psychotherapy [or ketamine] can help people with alcohol addiction to stop drinking is currently recruiting participants.
The study is called "Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse (MORE-KARE)". It is funded in a partnership between the NIHR (the UK's National Institute for Health and Care Research) and the Medical Research Council (MRC).
There is additional funding from the biotech company Awakn Life Sciences and the study is managed by the clinical trials unit at the University of Exeter.
The eligibility of the first patients is now being analyzed. The Phase III trial is being conducted by the University of Exeter and will initially be carried out in eight NHS units across the UK.
Very positive initial conclusions
This latest trial is based on very positive conclusions drawn from the Phase II trial. That earlier trial showed that for people with very severe alcohol disorder, the combination of ketamine and therapy is safe and tolerable. Participants who took the ketamine [or ketamine] treatment went from daily drinking to sobriety 86% of the time. This over a period of more than six months.
The new trial will deepen these conclusions. The aim is to make this treatment available on the national health service if it proves to be effective.
Professor Celia Morgan, from the University of Exeter, and international partner of The Clinic of Change, which is running the trial, said: "More than half a million adults in the UK have serious alcohol problems that need monitoring, yet only one in five receive adequate treatment. The treatments currently available have a low success rate - we know that three out of four people who stop drinking will do so again after a year. This new trial wants to fill a serious gap in the search for new treatments. We are very excited that there is NIHR support for this research, which is the largest research in the world dedicated to Ketamine-Assisted Psychotherapy."
In the 1980s, researchers had already identified a promising reduction in relapse rates after treatment with ketamine. More recent studies also show that ketamine [or ketamine] has rapid results in the treatment of depression. It can also speed up the learning of new information. These last two conclusions also contribute to the prevention of alcohol addiction.
In a recent study, the KARE treatment team provided new data on why ketamine is effective. A pilot trial with 28 people, in which some were treated with ketamine and others with placebo, always alongside psychotherapy, showed that ketamine makes treatment more effective by making the mind more predisposed to therapy, enhancing the patient's involvement.
Random distribution, psychological support
Participants will be randomly assigned to two different arms of the trial. Each group will be treated with a different dose of ketamine. All will receive psychological support from the trial team. The dose of ketamine and the type of psychological support for each participant will be randomly determined by a computer. This information will not be disclosed to either the patient or the research team.
To determine the effectiveness of the treatment, alcohol consumption will be monitored. This will be done through drinking diaries and daily breath tests. Participants will then have face-to-face follow-up sessions at 3 and 6 months. Recruitment is now taking place in Exeter and Oxford.
