The first clinical trial of using the DMT to treat depression has been given the go-ahead by UK regulators. VulcanChem
PASADENA, CALIFORNIA, UNITED STATES, December 17, 2020 /EINPresswire.com/ — The world’s first clinical trial testing the efficacy of the psychedelic compound N,N-dimethyltryptamine (DMT) has won approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The trial is a Phase I/IIa trial, meaning that it will test the safety of DMT and the efficacy of its treatment in a small number of patients. The trial is targeting major depressive disorder (MDD), a mental health condition that affects more than 16 million people in the US alone.
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 afterward 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.”
The treatment will be modeled 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 undergoes 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.
In a press release, Peter Rands said, “DMT delivers a psychedelic experience in 20 mins and has unique properties that lend themselves to clinical use. By adopting responsible evidence-based research and development into psychedelic medicine, we hope to help rebrand these once stigmatized compounds as highly effective medical therapies, which can be integrated into current healthcare systems and made accessible to the millions of people suffering from depression.”
About DMT: DMT is a tryptamine derivative having two N-methyl substituents on the side-chain. It is a tryptamine alkaloid and a member of tryptamines. DMT acts as a non-selective agonist at most or all of the serotonin receptors. Experimental studies state that DMT is an endogenous sigma-1 receptor agonist. DMT interacts with sigma-1 receptors and blocks voltage-gated sodium ion (Na+) channels in both native cardiac myocytes and heterologous cells that contain sigma-1 receptors. DMT was found to reversibly inhibit Na currents by 62% in vitro. N,N-Dimethyltryptamine also induced hypermotility in WT mice (but not in sigma-1 KO mice), all evidence of its sigma-1 agonist activity.