Alcoholics to be given ketamine to see if it reduces alcohol use
Alcoholics are being given ketamine-assisted therapy to see if it helps them stay off alcohol longer in a £2.4million Phase 3 trial.
The study, led by the University of Exeter and funded by the National Institute for Health and Care Research (NIHR), is being conducted at seven NHS sites across the UK.
The NIHR is funded by the Department of Health and Social Care and funds health and social care research in the UK.
It comes after a phase 2 study showed ketamine and the therapy treatment are safe and tolerable for heavy drinkers.
The earlier study found that participants who received ketamine in combination with therapy remained completely fast, which corresponds to 86% of abstinence at the six-month follow-up.
The Ketamine for Reduction of Alcohol Relapse (Kare) trial will now move to the next step in drug development, with the aim of introducing it to the NHS if proven effective.
Ketamine is an approved drug that is widely used as an anesthetic and for pain relief.
It is also used as a recreational drug and is classified as a Class B Prohibited Substance by the Home Office.
The study will recruit 280 people with alcohol problems who will be randomly divided into two groups.
Half receive ketamine at the dose used in the first clinical trial of psychological therapy.
The other half receive a very low dose of ketamine and a seven-session education pack on the harmful effects of alcohol.
Researchers will study whether the ketamine and therapy package reduces harmful drinking.
Study leader Professor Celia Morgan of the University of Exeter said: “More than two million adults in the UK have serious drinking problems, but only one in five of them are treated.
“Three out of four people who quit alcohol will drink heavily again after a year.
“Alcohol-related harm is estimated to cost the NHS £3.5bn a year and around £40bn to wider British society.
“Alcohol problems affect not only individuals, but also families, friends and communities, and related deaths have only increased since the pandemic.
“We urgently need new therapies.
“If this study finds that ketamine and therapy work, we hope we can start using it in NHS settings.”
The new study will recruit participants from across Imperial College London; Oxford Health NHS Trust; Greater Manchester Mental Health NHS Trust; North, East and West 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 begin in mid-2023.
Additional funding will be provided by Awakn Life Sciences, a biotechnology company focused on the discovery and development of therapeutics for the treatment of addiction.