Safety, blood levels and effects of N,N-dimethyltryptamine [DMT (SPL026)] in healthy participants that have taken psychedelic substances before (Part A) and in healthy participants with little to no psychedelic experience (Part B)

This open-label, crossover trial (n=30) will study the safety, blood levels, and effects of DMT (SPL026) in two groups: psychedelic-experienced healthy participants (Part A) and participants with little to no psychedelic experience (Part B).

Part A will involve up to 6 participants receiving single intramuscular (IM) doses of DMT followed by intravenous (IV) doses, while Part B will include up to 24 participants receiving single IM or IV doses based on Part A’s results.

The study aims to assess the safety, blood levels, and effects of DMT on mood, feelings, and thoughts. Participants must be aged 25-65 years and meet specific criteria regarding psychedelic experience. The study, funded by Cybin UK Ltd, was conducted at Hammersmith Medicines Research Limited, UK, from May 2022 to April 2023.

Topic Healthy Subjects Safety
Compound DMT
Country United Kingdom
Visit trial
Status Completed
Results Published No
Start date 22 May 2022
End date 05 April 2023
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 14
Sex All
Age 25- 65
Therapy No

Trial Details

This trial will investigate the effects of DMT in two groups: those with psychedelic experience and those without. It aims to assess safety, blood levels, and effects on mood and thoughts. Participants aged 25-65 will receive single doses of DMT via injection. The study runs from May 2022 to April 2023 in the UK.

NCT Number ISRCTN63723571

Sponsors & Collaborators

Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

Data attribution

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