Exclusive: UK regulators give go-ahead for drug to be trialled ahead of possible treatment alongside psychotherapy

UK regulators have given the go-ahead for the first clinical trial of the use of the psychedelic drug dimethyltriptamine (DMT) to treat depression.

The trial will initially give the drug – known as the “spirit molecule” for the powerful hallucinogenic trips it induces – to healthy individuals, but it is expected to be followed by a second trial in patients with depression, where DMT will be given alongside psychotherapy.

Taking the drug before therapy is akin to shaking up a snow globe and letting the flakes settle, said Carol Routledge, chief scientific and medical officer at Small Pharma, the company running the trial in collaboration with Imperial College London.

“The psychedelic drug breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections.

“Then the [psychotherapy] session afterwards is the letting-things-settle piece of things – it helps you to make sense of those thoughts and puts you back on the right track. We think this could be a treatment for a number of depressive disorders besides major depression, including PTSD, treatment-resistant depression, obsessive-compulsive disorder, and possibly some types of substance abuse.”

DMT is found in several plants and is one of the active ingredients in ayahuasca, a bitter drink consumed during shamanistic rituals in South America and elsewhere. DMT is also available as a street drug in the UK, where it classified as a class A substance, carrying a maximum penalty of seven years in jail for possession and life imprisonment for supply.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the trial on Monday, and Small Pharma is currently involved in discussions with the Home Office, which must also give permission because DMT is a controlled substance.

The hope is that the initial trial, which aims to establish the lowest dose of DMT that elicits a psychedelic experience, could begin in January. It will involve 32 healthy volunteers, who have never previously taken a psychedelic drug, including ecstasy or ketamine. This will be followed by trial in 36 patients with clinical depression.

The treatment will be modelled on studies of psilocybin – the psychedelic ingredient in magic mushrooms – in depression. Here patients are brought into a clinic, where they undergo a “setting” session, during which the clinician primes them to open their mind to the drug, and ensures that they are comfortable and relaxed. Next, they are administered the drug, and once the psychedelic experience ends, the patient immediately undergo a session of psychotherapy.

The difference with DMT is that the psychedelic experience comes on faster and more intensely, but is over more quickly. “Whereas a psilocybin session takes all day – and if you’re doing two or even more of those, that’s a large time commitment – a DMT session, all in, will probably take under two hours,” said Peter Rands, Small Pharma’s CEO.

“We expect DMT to be rapid-acting, equivalent or perhaps even better than psilocybin, so within hours of a session you will get rapid relief [from your depression]. We also expect the effect to be sustained over a similar time period.”

One recent trial of psilocybin and psychotherapy found a continued reduction in patients’ depressive symptoms four weeks after taking the drug.

Previous studies of ayahuasca have also suggested that it might have an antidepressant effect, said Amanda Feilding, founder and director of the Oxfordshire-based Beckley Foundation, which designs and develops psychedelic drug research to inform global drugs policy.

“I myself don’t find DMT to be a very lovable compound, but it is definitely an interesting study to do,” she said. “It is a harsher compound than other psychedelics like psilocybin or LSD, where the experience is more like a flower opening and receiving what’s already inside you.

“DMT triggers a strong [psychedelic trip], where people experience what they call ‘the entities’ – they meet beings who seem to be real, like being in a dream. But it can rather take one over.”

Unconventional therapy: which other illicit drugs are being investigated to help which illnesses?

Cannabis British doctors have been allowed to prescribe cannabis-based products to people with drug-resistant conditions, including epilepsy, since 2018. However, the high cost of products like full-extract cannabis oil means few are choosing to do so. A large UK trial is also assessing the drug’s effects on patients with chronic pain, epilepsy, multiple sclerosis, post-traumatic stress disorder (PTSD), Tourette’s syndrome, anxiety disorder or a history of substance misuse.

Psilocybin The psychedelic ingredient in magic mushrooms is being investigated alongside psychotherapy as a treatment for depression. Other studies are assessing whether it could help people to quit smoking.

LSD Microdoses of this psychedelic drug are showing promise as a non-addictive alternative for pain management.

MDMA Researchers in the US are exploring whether a combination of MDMA (ecstasy) and psychotherapy could help people recover from PTSD.

Ketamine A ketamine-like drug called esketamine, given as a nasal spray, was recently licensed for use in the UK as a treatment for severe depression.