BPL-5MEO – first doses in humans
Research type
Research Study
Full title
A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects (20-011)
IRAS ID
290995
Contact name
Ian MacLeod
Contact email
Sponsor organisation
Beckley Psytech Ltd.
Eudract number
2021-000552-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Research Summary:
This is a study of 5-MeO-DMT – a psychedelic substance that occurs naturally in some plants and animals. We’re testing 5-MeO-DMT as an experimental new drug for treatment-resistant depression (TRD). Depression is a common mental illness that affects more than 350 million people worldwide. There are existing treatments for depression, but they don’t work well in all patients. About a third of patients (30–40%) have TRD, meaning their depression doesn’t respond to at least 2 commonly available treatments. 5-MeO-DMT stimulates the serotonin system in the brain – a system known to regulate mood and a sense of wellbeing. We believe 5-MeO-DMT will provide relief from depression for patients for whom other treatments haven’t worked.
We’ll give up to 56 healthy men and women aged 25–55 single doses of the 5-MeO-DMT or placebo, as a nasal spray. We’re doing the study in volunteers who are experienced users of psychedelic substances and volunteers who’ve never taken a psychedelic substance. 5-MeO-DMT has never been given to humans in a clinical study before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects, blood levels, psychedelic effects, and its effects on mood, feelings, and the ability to read facial expressions.
Participants will take about 1 week to finish the study. They’ll have a screening visit during the 8 weeks before their dosing visit. Depending on their previous experience with psychedelic drugs, they’ll have 1–2 psychedelic preparation visits (or video call) with an experienced psychedelic researcher in the week before their dosing visit. They’ll then stay on the ward for 1 night and have up to 2 follow-up visits.
A pharmaceutical company (Beckley Psytech Limited) is funding the study.The study will take place at 1 centre in London.
Summary of Results:
BPL-5MeO-101: A double-blind, randomized, phase 1, first-in-human, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of intranasal 5 Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in healthy subjects.
We would like to thank everyone who participated in this study. This document is a summary of the study. It is written for a general audience. Researchers look at the results of many studies to understand which drugs work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary only shows the results from this one study. Other studies evaluating the same drug may find different results.
Why was this study done?
BPL-5MeO is a liquid nasal spray containing 5-MeO-DMT. 5-MeO-DMT is a psychedelic. Some people have reported health benefits after taking psychedelics. This is an early study that will help researchers plan future studies. After BPL-5MeO is sprayed into the nose it enters the body and moves to different areas after which it is removed from the body. The main aim of the study was to find out what side effects occur following administration of BPL-5MeO. In addition, researchers wanted to find out the levels of 5-MeO-DMT in the blood after different amounts were sprayed into the nose.When and where did this study take place?
This study started in September 2021
It ended in July 2022.
This study was conducted in London at the NIHR Wellcome Clinical Research Facility, King’s College Hospital.Who participated in the study?
36 volunteers participated in this study. In order to take part, the following main criteria had to be met (Note – this is not the full criteria):
• Be aged from 25 – 55 years (inclusive) • Healthy with no findings on a physical examination, blood tests or electrocardiogram (which is a test of how the heart is working) • Not have taken a psychedelic in the past.
• Have a body mass index, which is a calculation based on height and weight, of 18.0–30.9 kg/m2.Which treatments did participants receive?
The study drug was BPL-5MeO, a liquid nasal spray of 5-MeO-DMT, or placebo. The placebo looked the same as BPL-5MeO but did not have any real drug in it. 12 participants received placebo and 24 participants received BPL-5MeO. The study drug was administered along with psychological support. 30 participants received one single spray into one nostril. 6 participants received two sprays, one in each nostril. The amount of BPL-5MeO ranged from 2.5 mg to 14 mg.How was the study done?
In this study, researchers looked at how this drug works in the human body. Researchers did medical tests on participants before and after they took the drug. The researchers wanted to know if there were:
• Any chemical changes in blood, and
• Any unwanted side effects of the drug
This trial did not test if the drug helped to improve health.
This study is called a single ascending dose trial. In this type of study one dose strength is given to some of the participants and the study results collected and analysed. If it is assessed safe to do so the next group of participants receive a higher dose.
This study is called a “randomized” study which means that participants were put into the placebo or BPL-5MeO group by chance.
This study was also “double-blinded”. This means that neither participants nor doctors knew who was given BPL-5MeO and who was given placebo. This was done to make sure that the trial results were not influenced in any way.
All participants visited the study clinic once before the study started to make sure they met the criteria required to participate in the study. Participants attended 2 meetings with the psychedelic monitor, a type of therapist before the dosing. The psychedelic monitor explained what to expect from a psychedelic experience and discussed ways to navigate the experience. After receiving the dose on the treatment day participants remained at the clinic until the next day. Researchers took samples of blood from participants to measure the amount of 5-MeO-DMT in their blood. The psychedelic monitor remained with the participant after the dosing to provide psychological support if needed. The participants attended a meeting 3 days after dosing to discuss the experience with the psychedelic monitor. The final meeting with the research team was 7 days after the treatment day.
What were the side effects?
Like all medicines, the study drug can cause side effects, although not everybody gets them. Side effects are unwanted events thought to be related to the treatments in the study. The most common side effects in this trial which occurred in more than 10% of participants were:
Side Effects – Participants who received placebo or BPL-5MEO :
• Short term increases in blood pressure = Placebo - 3 (25%) / BPL-5MEO = 9 (37%) • Short term increases in heart rate = Placebo - 1 (8%) / BPL-5MEO = 5 (21%) • Throat irritation = Placebo – 0 / BPL-5MEO = 12 (50%) • Nasal discomfort = Placebo – 0 / BPL-5MEO = 4 (17%)What were the study results?
The study was completed as planned.
All side effects were mild or moderate in severity and most went away within 2 hours. All of the participants who received BPL-5MeO told the researchers they would be prepared to receive the same dose, or a higher one, again in the future.
The highest amount of 5-MeO-DMT was found in the blood approximately 30 minutes after it was sprayed into the nose. All of the 5-MeO-DMT was gone from the blood after approximately 2 and a half hours.How has this study helped patients and researchers?
Findings from this trial will be used in other studies to find whether patients with various psychiatric diseases are helped by 5-MeO-DMT.Are there plans for further studies?
No further studies with the liquid nasal spray BPL-5MeO are planned at the current time. Clinical trials with a dry powder nasal spray BPL-003 are ongoing and further trials are planned.Further information
If you have questions about the results of your study, please speak with the doctor or staff at the study site.
For more details on the study protocol, please visit:
https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Cbrent.rec%40hra.nhs.uk%7C82ad6fc67bf14d857ff108db7ef7d14a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638243375055672775%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=FM6o%2FlBMltEJDxD5QCqjJh6cyNlFBlnD6BeQlLedYv0%3D&reserved=0 Use the study identifier NCT05032833
The identification numbers of this clinical study are • Protocol Number: BPL-5MeO-101 • EudraCT Number: 2021-000552-19The company organising and funding the research, called the “Sponsor”, is Beckley Psytech Ltd.
Again, if you participated in this study, thank you for volunteering
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0110
Date of REC Opinion
6 Apr 2021
REC opinion
Further Information Favourable Opinion