United Kingdom NHS figures suggest over 7.5 million people in the UK live with alcohol use disorder (AUD), commonly referred to as alcohol dependency. Treating AUD is a pressing concern for the UK health system. Data from Public Health England shows there were 20,970 deaths related to alcohol in England in 2021, and from 2021 to 2022, there were 342,795 hospital admissions that were wholly due to alcohol, equating to 1 in 160 people. A growing body of research suggests that psychedelic drugs could be a pioneering force in the treatment of complex mental health conditions including substance use disorders. There have been already small trials and pre-clinical tests about psylocibine, for example, and the possibility for a “brain defrag” to reset the neurochemistry in major depression.
The other example is ketamine, whose prescription version called esketamine (Spravato), given through a nasal spray, has been approved in 2019 to treat resistant depression. Modern mental health company Clerkenwell Health announced today that it is working with clinical-stage biotechnology company Beckley Psytech on a Phase IIa study investigating whether a novel psychedelic compound, combined with psychological support, could be an effective treatment for AUD. The trial, which is already underway at King’s College London, will evaluate the safety, tolerability and pharmacodynamic effects of a single dose of BPL-003, in combination with abstinence-oriented psychological support.
BPL-003 is a novel, synthetic formulation of mebufotenin (5-MeO-DMT) which is a psychedelic of the tryptamine class naturally found in several plant species and the glands of at least one toad species. Basically, it is a serotonin-like agonist that acts on brain serotonin receptors (mainly the 5HT-2A subtype) to simulate the effect of other natural allucinogens like psylocibin, psylocine, lespedamine, LSD and DMT (dimethyl-tryptamine). BPL-003 is administered intranasally and can elicit psychedelic experiences of similar intensity but shorter duration than psilocybin, which is found in ‘magic mushrooms’ and has shown early promise in substance abuse disorders.
Participants will be followed for 12 weeks after initial dosing, with safety, pharmacokinetic and efficacy assessments conducted at multiple points throughout that period. The trial will now go ahead as well at Clerkenwell Health’s clinic in London. The novel combination of staged psychological support and the administration of a psychedelic compound in the presence of a trained counsellor is a paradigm shift for the substance abuse disorder and mental health treatment sector which has seen no significant new treatment options developed for a number of decades. The results of this AUD trial may be used to provide support for further study of psychedelic-assisted treatment for alcohol dependency.
Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, said: “An estimated 600,000 people are dependent on alcohol in England. This, coupled with an alarming increase in alcohol-related deaths of 89% over the past 20 years, shows the status quo isn’t working. Conventional treatments for alcohol dependency aren’t producing meaningful improvements and new avenues must be explored. This trial will assess whether psychedelic-assisted treatment can be an effective therapy for alcohol use disorder, with the hope of rolling out the treatment widely. Health professionals and policymakers should seriously consider such treatments, which could be genuinely ground-breaking for the NHS and for the hundreds of thousands of people being treated for alcohol use disorder in the UK.”
- Edited by Dr. Gianfrancesco Cormaci, PhD, specialist in Clinical Biochemistry.
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