A new study seeks to understand whether psychological therapy associated with ketamine can help alcoholics stop drinking. The study is already in phase 3.
Led by the University of Exeter, the new study is funded by the National Institute for Health and Care Research (NIHR) in the UK, with additional funding from Awakn Life Sciences, a biotech company specializing in the research and development of therapies for addiction treatment, for a total of £2.4 million.
The latest trial builds on the positive results of a previous phase II study designed to test the safety of the treatment . The study demonstrated that treatment with ketamine and psychological therapy is safe and tolerable for people with severe alcohol use disorder. The previous study found that participants who took ketamine in combination with therapy remained completely sober , with 86 percent abstinence over the six-month follow-up. Now the Ketamine for Reduction of Alcohol Relapse (KARE) study will move into the next phase of the drug’s development, a Phase III study. It will test this promising discovery further, with the aim of introducing it into thenational health system if it proves to be effective.
The trial will be conducted in collaboration with the NHS and the treatment will be administered at seven NHS sites across the UK. The study will recruit 280 people with severe alcohol use disorder and participants will be randomly assigned to two groups. One group will be given ketamine, at the dose used in the first clinical study, along with psychological therapy. The other half will receive a very low dose of ketamine and a seven-session educational package on the harmful effects of alcohol.
Professor Celia Morgan, from the University of Exeter, said: ‘More than two million UK adults have serious drinking problems, yet only one in five seek treatment. Three out of four people who give up alcohol return to heavy drinking after a year . Alcohol-related harm is estimated to cost the NHS around £ 3.5 billion and British society at large around £40 billion each year.of pounds. Alcohol-related problems affect not just the individual, but also families, friends and communities, and related deaths have increased further since the pandemic. We urgently need new treatments. If this study establishes that ketamine and therapy work, hopefully we can start to see its use in NHS settings.”
Professor Anne Lingford-Hughes, Lecturer in Addiction Biology at Imperial College London and Consultant Addiction Psychiatrist at Central North West London NHS Foundation Trust, said: “This is the largest study of its kind in the world and it builds on our previous study. We currently have few effective treatment options for people with alcoholism, and not all of them work for everyone. We therefore desperately need new treatments that use different approaches, like this study, to help people regain control of their lives and reduce the immense harm caused by alcohol.”
“By bringing together the specific biochemical effects of ketamine and the supportive, structured, change-focused space of psychotherapy , this study should finally establish the utility of this approach to addiction treatment,” said Dr. University of Manchester study “Ultimately, this study should lead to an increase in treatment options for people with alcohol dependence, who currently have very few treatment options, when it comes to helping them stay sober or develop a healthy relationship with alcohol after a detox.”
- Ketamine and psychological therapy helped severe alcoholics abstain for longer in trial (exeter.ac.uk)