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 alcohol use disorder (AUD).
NHS figures suggest over 7.5 million people in the UK live with AUD – commonly referred to as alcohol dependency.
The open-label trial (NCT05674929), which is already underway at King’s College London, will evaluate the safety, tolerability and pharmacodynamic effects of a single dose of Beckley Psytech’s lead candidate, BPL-003, in combination with abstinence-oriented psychological support in participants with AUD. 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 near Harley Street, London and people interested in participating in this trial can register here.
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. 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.
Treating AUDs 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.
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.”
We're committed to developing a transformative and effective treatment option for individuals struggling with alcohol use disorder. Based on our preclinical and Phase I data, we are optimistic about the potential therapeutic benefits of BPL-003 for substance use disorders and we are excited to evaluate the compound further in this clinical trial. I want to extend my thanks to the team at Clerkenwell Health and King’s, as well as to the patients who have joined, and will join, this study. Their participation, support and collaboration are absolutely critical to furthering research into this area of huge unmet need.”
Dr Rob Conley, Chief Medical and Scientific Officer, Beckley Psytech
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.
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.
Alcohol consumption raises pain threshold and aggressive behavior