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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

    ian@beckleypsytech.com

  • Sponsor organisation

    Beckley Psytech Ltd.

  • Eudract number

    2021-000552-19

  • Duration of Study in the UK

    0 years, 11 months, 30 days

  • 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.

  • 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