Alcoholics to be given ketamine to overcome addiction in largest-ever trial
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Ketamine and therapy could help alcoholics overcome their addiction.
Led by the University of Exeter, a new £2.4 million phase III trial —the largest of its kind — delivered across seven NHS sites in the UK will look into the concoction of ketamine-assisted therapy and if it could help alcoholics stay off alcohol for longer.
The latest trial is a follow-up on the positive result of an earlier proof-of-concept phase II trial by the Ketamine for Reduction of Alcohol Relapse team, which determined if the treatment was safe.
Building on an earlier, positive trial
Anne Lingford-Hughes, professor of Addiction Biology at Imperial College London and Consultant Addiction Psychiatrist at Central North West London NHS Foundation Trust, said in a statement: "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.
Not only did the earlier study show that ketamine and therapy were safe for people with severe alcohol use disorder, but it also found that the participants stayed completely sober - there was an 86 percent abstinence noted in the six-month follow-up.
The need for new treatments
A licensed medical drug, ketamine is widely used as an anesthetic and in pain relief. It is also used as a recreational drug and is classified as a Class B banned substance by the Home Office.
Researchers will recruit 280 alcoholics in the summer to take part in the phase three trial. The patients will be randomly allocated to two arms - while one 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.
Trial lead Professor Celia Morgan, from the University of Exeter, said: "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."
Ketamine promotes the growth of new synapses in the brain
Morgan told The Guardian that the low dose wouldn't necessarily have any therapeutic effects but would help keep the participants unaware of their study groups. This would help the team control for placebo effects.
"In our proof of concept study, people were experiencing some quite unusual things like having out-of-body experiences, feeling like they were having these insights and epiphanies into their life," she said.
Such experiences could help the participants change their perspectives. The ketamine "promotes" the growth of new synapses in the brain.
"We time one of our psychological therapies so that the brain is really primed for new learning," she told The Guardian.
Understanding the mechanisms of the ketamine-assisted therapy treatment
The participants will be followed up at three and six months.
"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," said 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.
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