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.
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