Safety, blood levels and effects of N,N-dimethyltryptamine [DMT (SPL026)] in healthy participants and participants with major depressive disorder
Depression is a common mental health condition that can be hard to treat. This clinical study tests an experimental medicine called SPL026, which contains DMT. DMT is a natural psychedelic substance known for causing short, intense changes in perception and emotion. Researchers want to find out whether giving DMT through a slow injection into a vein is safe and whether it helps lift depression. The trial has two parts: one with healthy volunteers to see how the body handles the medicine, and another with adults who have major depression. Participants receive their dose in a hospital setting with trained therapists present throughout. The psychedelic experience usually lasts around 20 minutes. The study involves staying on a ward for two nights, followed by regular check-ins and video calls over three months. The results will help doctors understand if psychedelics could offer new hope for treating depression.
At a glance
What is this study about?
Major depressive disorder is a serious illness that affects millions of people across the UK. While standard treatments such as talking therapies and antidepressant tablets help many people, they do not work for everyone. Even when they do work, they can take weeks or months to provide relief. Because of this, scientists are actively researching new, faster-acting ways to support the brain, including the use of psychedelic compounds.
This trial focuses on a substance called DMT (prepared for research as SPL026). DMT is a naturally occurring psychedelic found in various plants and animals. It is best known as the active ingredient in ayahuasca, a plant mixture used for centuries in South American ceremonies. In medical research, DMT causes a brief but intense psychedelic experience—often called a 'trip'—lasting roughly 20 minutes. During this time, a person's thoughts, senses, and emotions temporarily shift.
Researchers want to see if DMT can help 'reset' brain circuits linked to low mood. The study looks at how the drug travels through the bloodstream, how quickly the body clears it, and what emotional effects it produces. By testing the medicine in both healthy volunteers and people living with depression, the research team hopes to learn whether DMT is safe and whether it holds promise as a future medical treatment.
Key takeaways
- Testing whether DMT can safely and quickly reduce symptoms of depression.
- Includes a two-night stay at a specialist clinic in London or Liverpool.
- The psychedelic experience lasts around 20 minutes with trained therapists present.
- Open to healthy volunteers (aged 25+) and people with depression (aged 18+).
- Health and mood are monitored closely for three months after treatment.
Who may be eligible?
The trial is divided into two separate groups. The first group (Part A) is for healthy adults aged 25 or older who have never taken any psychedelic drugs before. The second group (Part B) is for adults aged 18 or older who have been diagnosed with major depressive disorder and have not taken any psychedelic substances in the past six months.
To be eligible, you must be in good general physical health, with normal blood pressure, heart rhythm, and blood test results. You must also have access to the internet for follow-up video calls. If you have depression, you must either not be taking antidepressants or be willing to safely stop taking them under medical supervision before the study starts.
You cannot take part if you are pregnant or breastfeeding, have a history of drug or alcohol dependence, or smoke heavily. People with serious physical health conditions, such as liver infections or heart problems, are also unable to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or over (or 25+ if I am a healthy volunteer).
- I have major depression, OR I am healthy and have never tried psychedelics.
- I have not used psychedelic drugs within the past 6 months.
- I am not currently pregnant or breastfeeding.
- I am willing to stop antidepressant medicines under a doctor's guidance.
- I can travel and stay two nights at a trial clinic in London or Liverpool.
What does participation involve?
Taking part involves an initial screening visit to check your general health, followed by a stay of three days and two nights at a specialist clinical ward in London or Liverpool. During your stay, you will receive two doses given as slow injections into an arm vein over 6 to 11 minutes. One dose may be a dummy medicine (placebo) to ensure fair comparison, but all participants receive DMT during the trial. Specially trained therapists will remain at your side before, during, and after each 20-minute psychedelic experience to offer guidance and support. After leaving the ward, you will have video check-ups around seven days after each dose, an in-person clinic visit two weeks after your final dose, and follow-up calls at one month and three months to see how you are feeling. The entire study lasts about three to four months.
Potential risks and benefits
Locations (2)
- Hammersmith Medicines Research LimitedCity onlyLondon, England
- MAC Clinical Research LiverpoolCity onlyLiverpool, England
Common questions
Is DMT legal to take in this trial?
Yes. While DMT is normally a Class A drug in the UK, the researchers have special government licences to test it safely and legally in a controlled hospital environment.
Will I be left alone during the psychedelic experience?
No. Trained therapists and clinical staff will stay in the room with you the entire time to make sure you feel safe and supported.
Do I have to stop my regular antidepressants?
Yes. If you join the depression group, you must pause your regular antidepressant medication before the study starts, guided safely by study doctors.
Can I keep taking DMT once the trial is over?
No. DMT is an experimental drug undergoing testing and cannot be prescribed or taken after your study visits are complete.
How long does the psychedelic effect last?
The active experience from DMT is unusually short compared to other psychedelics, typically lasting about 20 minutes from the time of injection.
How to find out more
David Erritzoe
Always speak to your GP or specialist before deciding to take part in a study.
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