Researchers are hoping a new treatment combination will help with alcoholism.
The active ingredient of magic mushrooms, MDMA, is one of the drugs being studied to tackle mental health problems such as depression and post-traumatic stress disorder.
The trial will be the largest of its kind and will look at the use of ketamine in treating alcohol use disorders.
The leader of the new trial said that people with alcohol problems could find it difficult to engage in psychological interventions.
She said that the model is using the drug as a catalyst.
The team behind the study, known as Ketamine for Reduction of Alcohol Relapse (Kare), previously completed a proof of concept trial that suggested people with severe alcohol use disorder who were given ketamine together with psychological therapy were more likely to remain completely Abstinent six months later than
The aim of the phase 3 trial is to find definitive evidence of the effect so that we can roll out the treatment to patients.
Some of the studies used a one-off memory disruption intervention to tackle alcohol problems with a ketamine-based treatment.
Morgan noted that the group with severe alcohol use disorder is the most difficult to treat and the most likely to return to drinking.
The participants will be divided into two groups based on the previous work.
Half of the participants will be given three separate injections of a very low dose of ketamine over a period of one to two months with educational sessions about relaxation and the harmful effects of alcohol given before and after each injection.
Morgan said the very low dose was not expected to have any therapeutic effects but would help to keep participants unaware of which of the two study groups they were in.
The other group of participants will be given a larger dose of the drug and seven psychological therapy sessions. Morgan said that the level of the drug was comparable to a large recreational dose.
She said that people in the proof of concept study felt like they were having insights into their lives.
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Morgan said that such experiences can be useful in helping participants shift their perspective and view their alcohol problems in a different way.
She said that one of the therapies they use is to make the brain ready for new learning.
The groups of participants will be followed for three and six months, with their alcohol measured via a combination of self-report, smartphone-mounted breathalysers and Wearable Devices.
At six months, we are looking for differences in abstinence.
Morgan said that the drug alone wasn't thought to help people with alcohol problems.
The trial was welcomed by a professor of neuroscience at King's College London.
This larger investigation is needed because of the earlier trial. He said that we need to better understand the mechanisms of the treatment effect so that patients most likely to respond can be selected. We can learn about the most effective ways to refine treatment in the future.
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