A new £2.4 million phase III trial delivered across seven NHS sites including Oxford Health NHS Foundation Trust will investigate whether ketamine-assisted therapy could help alcoholics stay off alcohol for longer.

Oxford Health will be recruiting patients with alcohol-use disorder to determine if a short course of ketamine alongside psychotherapy reduces heavy drinking days for people six months after treatment.

Participants will be supported to abstain from alcohol ready for the start of the study. They will receive ketamine alongside mindfulness relapse-prevention therapy or alcohol education.  The placebo arm involves low dose ketamine and education about alcohol.

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 found that participants who had ketamine combined with therapy stayed completely sober, representing 86 per cent abstinence in the six month follow-up. Now, the Ketamine for Reduction of Alcohol Relapse (KARE) 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 at Oxford Health NHS Foundation Trust plus six other NHS sites across the UK. The trial will recruit 280 people with severe alcohol use disorder and participants will be randomly allocated to two 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 seven-session education package about the harmful effects of alcohol. Researchers will look at whether the ketamine and therapy package reduces harmful drinking.

Oxfordshire Consultant Psychiatrist Dr Rupert McShane said: “Oxford Health will be recruiting patients with alcohol-use disorder for this important study, which aims to answer the question, ‘Does a short course ketamine and adjunctive psychotherapy reduce heavy drinking days six months later?’.

“In the UK more than half a million adults have alcohol problems. But only one in five people with alcohol problems get treatment. Even of those who quit alcohol, three out of four 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. Alcohol-related deaths have increased still further since the pandemic and we urgently need new treatments.”

The new trial is being led by the University of Exeter and funded by the National Institute for Health and Care Research (NIHR) with additional funding from Awakn Life Sciences, a biotech company specialising in researching and developing therapeutics to treat addiction.

It will recruit participants across the following partner 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. To pre register interest in taking part, contact morekare@exeter.ac.uk