5MEO - Alcohol Use Disorder
Research type
Research Study
Full title
An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder
IRAS ID
1005284
Contact name
Beckley Psytech Ltd
Contact email
Sponsor organisation
Beckley Psytech Ltd
Eudract number
2022-000810-33
Clinicaltrials.gov Identifier
Research summary
This is a study of 5-MEO-DMT (BPL-003; the study treatment) – a psychedelic substance that occurs naturally in some plants and animals. 5-MeO-DMT is being tested as an experimental new medicine for Alcohol Use Disorder (AUD). The study will determine the side effects and potential benefits as well as the psychedelic effects of the study drug in patients with AUD. The dose of BPL-003 to be given in this study will be determined from a study in healthy volunteers, which will be completed before this study can begin. The dose will be safe and well tolerated by the healthy volunteers.
Drinking alcohol is widely socially accepted, however a number of people consume alcohol in a way which is potentially harmful to their health and/or wellbeing. A proportion have a significant degree of addiction to alcohol, which makes it difficult for them to reduce their drinking or abstain.
5-MeO-DMT acts at sites in the brain (called serotonin receptors) that are related to mood and mental health. We hope the study drug will give patients with AUD more treatment options.
BPL-003 will be given to a total of 12 men and women aged 18-64 years with diagnosed AUD, but who are otherwise healthy. A single dose of the study treatment will be given, as a spray up one nostril.
Participants will take up to 16 weeks to finish the study. They will make up to 18 outpatient visits. Outpatient visits will include 3 psychedelic preparation visits with an experienced psychedelic therapist in the week before their dosing visit, as well as weekly relapse prevention intervention with an AUD therapist.A pharmaceutical company, Beckley Psytech Ltd, is the study Sponsor and is funding the study.
The study will take place at 1 centre in London
What were the study results?
Of the 13 participants who entered the study 10 were male (76.9%), 12 were white (92.3%) and ages
ranged from 27 – 62 years with an average of 49 years.
Alcohol use by the participants was reduced over the 12-week study period. Six of the 12
participants (50%) who completed the study did not drink any alcohol during the 12 weeks after
receiving the study drug, three (25%) had substantial reductions in alcohol consumption; and three
(25%) had no change or a limited change in their drinking patterns. The average percentage days
during which participants did not drink any alcohol increased from 33.2% at the start of the study to
80.8% at the end. The average percentage of HDD reduced from 56.2% to 13.2%. Overall, measures
of the negative consequences of alcohol, craving, and well-being indicated improvement. All of the
participants reported feeling improved at the end of the study with 9 of the 12 (75%) feeling much
or very much improved.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0297
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion