Recently the Medicines and Healthcare products Regulatory Agency of the United Kingdom has approved the first clinical trial of the use of the Psychedelic substance N,N-Dimethyltryptamine (DMT), to treat depression.
Rick Strassman, one of the pioneer researchers of DMT, researched DMT for more than two decades and called this substance ‘Spirit Molecule’ as it occurs naturally in the Plant and animal kingdom.
DMT is often also an active compound in the Holy Medicine of the Holy and Divine Mother Ayahuasca, which historically originates from the Amazons, with a history of thousands of years – and has been revered for the various roles including ‘Healing’, spiritual enlightenment, divination, and more. The Holy Medicine helped the indigenous people of Amazons to enhance their psychic ability and skills, to sharpen their senses before hunting. Nowadays, DMT is also available as a street drug in the UK, where it is identified as a class-A narcotic.
Small Pharma, the company processing this trial in collaboration with Imperial College London, was involved in discussions with the Home Office of the UK, which also must approve this trial because DMT is a controlled substance in the UK. With the permission of the Home Office, the first part of the trial has already started in February of 2021.
The trial is divided into two parts.
- Part A or Phase I is the first phase of the study which started in February of 2021, presently evaluating the effects of DMT-assisted therapy in healthy individuals who have never previously experienced DMT or other Psychedelic drugs like ecstasy or ketamine.
- Part B or Phase IIa or in the second part of this trial will test the efficacy of DMT-assisted therapy in patients suffering from MDD (Major Depressive Disorder). This will be the first patient clinical trial using DMT for depression.
Existing research done by Robin Carhart-Harris, who is a neuroscientist and psychologist and the head of the Centre for Psychedelic Research Division, highlights the application of supporting therapy to improve the potential therapeutic benefit from the DMT dosing experience.
This clinical trial will combine psychological support provided by trained psychiatrists alongside the administration of Small Pharma drug products. During the session, two psychiatrists will be present to provide support and guidance.
According to Carol Routledge, the chief medical and scientific officer at Small Pharma, taking the drug before therapy is like shaking up a snow globe and letting the snowflakes settle. She further explained this to The Guardian – “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 trial is designed on the studies of psilocybin of magic mushrooms in depression. Where the patients are brought into a clinical environment and undergo a setting session, during which the participants receive a number of preparation sessions to help them feel at ease with the psychiatrist and the setting of the dosing session. With the help of the psychiatrist, patients explore their intentions for the trial session. In the DMT dosing session, the participants receive a single administered DMT injection in a calming, comfortable room while lying down on a bed and listening to a specifically engineered music playlist. During this session, two psychiatrists will be present the whole time.
In the third phase of the session, participants are encouraged to discuss their experiences with the psychiatrists. This phase encourages patients to integrate insights from the session with an intention to guide breaking away from behavioral and challenging emotional patterns.
The recent trial of psilocybin and psychotherapy lead by Alan K. Davis and his team found a continued reduction in depressive symptoms of the patients even after four weeks of taking the drug. Amanda Feilding, director and founder of the Oxfordshire-based Beckley Foundation, which develops and designs psychedelic drug research to inform global drugs policy, mentioned that the previous studies on the Holy Medicine also suggested the Holy Medicine may potentially be contributing to have an antidepressant effect.
This latest development towards understanding the nature of Psychedelic compounds and their application in reducing depression clearly speaks to a very exciting time in psychiatry, pharmacology, and psychology. Studies like this may lead us to a future where innovative thinking on display by Small Pharma and the Centre for Psychedelic Research may produce the answer humanity is seeking for ‘healing’ mental diseases, depression, ADHD, PTSD, and any other mental conditions.
Davis AK, Barrett FS, May DG, et al. (2020) Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry, [online] Volume, 78(5), p. 481–489. Available at: https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2772630 [Accessed 28th June 2021].
Small Pharma, (2020). About Our Depression Study. [online] Available at: https://www.smallpharma.co.uk/our-clinical-trials [Accessed 28th June 2021].
Small Pharma, (2020). DMT-Assisted Therapy. [online] Available at: https://www.smallpharma.co.uk/spl026-project [Accessed 28th June 2021].