Safety, blood levels and effects of DMT (SPL026); version 1
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled study of intravenous doses of SPL026 (DMT fumarate), a serotonergic psychedelic, in healthy subjects (Part A) and patients with major depressive disorder (Part B) (HMR code 20-506)
IRAS ID
288450
Contact name
Ellen James
Contact email
Sponsor organisation
Small Pharma
Eudract number
2020-000251-13
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
This is a study of DMT (the study medicine) – a psychedelic substance that occurs naturally in plants and animals. We’re testing DMT as an experimental treatment for Major Depressive Disorder (MDD). MDD, or ‘depression’, is a common mental illness that affects about 322 million people worldwide. There are existing treatments for depression, but they don’t work well in all patients.
DMT acts at sites in the brain (called serotonin receptors) related to mood and mental health. We hope DMT will give patients with depression more treatment options.
We’ll test single doses of DMT (given by slow injection into a vein) to assess: its safety; how well it’s tolerated; its blood levels; psychedelic effects; and effects on mood, feelings, thoughts and beliefs.
The study is in 2 parts.
In Part A, we’ll give up to 32 healthy volunteers (who’ve never taken a psychedelic substance before) a single dose of DMT or placebo. We’ll start with a low dose and increase it as the study progresses. Participants will take up to 13 weeks to finish the study and have 1 study session. They’ll stay on the ward for 2 nights, and have 3 follow-up phone or video calls.
In Part B, we’ll give 28–36 MDD patients up to 2 single doses of DMT (they may receive placebo instead of 1 dose of DMT). They’ll take up to 3.5 months to finish the study and have 2 study sessions. They’ll stay on the ward for 4 nights in total, have 1 follow-up visit, and up to 5 follow-up phone or video calls.
Participants will attend a screening visit during the 3 weeks (Part A) or 3 months (Part B) before the study.A pharmaceutical company (Small Pharma, UK) is funding the study.
The study will take place at 2 centres in London.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/1035
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion