United Kingdom

Psilocybin

KEY TAKEAWAYS

  1. Psilocybin-assisted therapy for depression (MDD and TRD) is finishing phase II clinical trials and may become a licensed therapy as early as 2025.
  2. Academic studies conducted around the world using psilocybin with accompanying psychological support (PAT) are demonstrating rapid and long-lasting positive effects on patients suffering from depression and anxiety. In one study the positive effects were still evident up to four and a half years later.
  3. Next to health care reimbursed therapies, decriminalisation efforts are opening another avenue through which psilocybin, ‘magic mushrooms’, can become a tool for the improvement of mental well-being.

Psilocybin is a psychedelic that can be derived from over 200 varieties of fungi. Since its isolation in 1958 by Albert Hofmann, a variety of synthetic methods for producing psilocybin have been found. A human body quickly metabolises psilocybin into psilocin which is the pharmacologically active agent which interacts with several serotonin receptors in the brain. Specifically, it is best known for being a 5-HT2a agonist, meaning it can change serotonin activity in the human brain and disrupt dysfunctional brain connectivity. Through these and other mechanisms, psilocybin thus offers a potent new alternative for the treatment of a wide variety of mental health conditions.

Psilocybin in the United Kingdom

In 2017, Imperial College London conducted a psilocybin study with 16 patients suffering from TRD, using fMRI technology to measure changes in brain function in the subjects before and after doses of psilocybin were administered. The study found that psilocybin, with accompanying psychological support, produced rapid and sustained antidepressant effects, with the potential to ‘reset’ the brain, offering a potential new treatment for TRD. The College’s Centre for Psychedelic Research is positioning itself to serve as a model research clinic that serves as a prototype for the licensed psychedelic care facilities set to be a feature of mental health services in the future.

The Centre for Affective Disorders at King’s College London established a psychedelic trials group, which received funding from the National Institute for Health Research (NIHR) in 2017, to investigate the safety and efficacy of psilocybin for patients with TRD, coupled with a suite of psychological supports and medical supervision, through a randomised, placebo-controlled trial. The centre, which is headed up by Professor Allan Young, is currently involved in trials sponsored by mental health care company COMPASS Pathways, which began in 2019.

The phase II study, which was also conducted at 21 other sites in Europe and North America, of psilocybin-assisted therapy for TRD, was completed in June 2021. COMPASS Pathways will publish the results of this trial in late 2021. The trial is the largest of its kind to date and has treated 216 patients. At this time, COMPASS Pathways is furthest along with making psilocybin, specifically their proprietary COMP360, into a medicine.

LSD

KEY TAKEAWAYS

  1. LSD was widely studied in the 1960s and generated over 1000 scientific papers. These studies showed positive developments in reducing anxiety during ‘end-of-life’ care, depression and alcoholism.
  2. Modern-day studies using fMRI are enlightening researchers about the way everyday consciousness functions and how the hierarchy of the brain is ‘flattened’ or ‘segregated’ under the influence of LSD.
  3. The duration of an LSD trip makes it a less likely candidate to be developed as a medicine. Its microscopic effective dose and widespread use in recreational microdosing do still show opportunities for the further study of this psychedelic.

Lysergic acid diethylamide (LSD, LSD-25, acid) is a serotonergic psychedelic. LSD binds to serotonin receptors, specifically the 5-HT2a receptor, as well as dopamine receptors (which psilocybin doesn’t bind to). The effects of LSD are noticeable at dosages measured in the millionths of a gram. Research studies use between 50 and 200 micrograms, which can produce effects for upwards of 12 hours. The study of LSD played a pivotal role in the discovery of the function of serotonin in the brain. Although widely studied in the 1960s, LSD is trailing behind psilocybin in terms of scientific interest.

Psilocybin the United Kingdom

At Imperial College London (ICL), the Centre for Psychedelic Research (CPR) was set up in 2019, backed by five founding investors who contributed £3 million to get the project off the ground. The stated purpose of this research centre is two-fold: to investigate the potential of psychedelics in treating mental health disorders and secondly to probe the basis of human consciousness using the most modern imaging techniques available. One of the first studies conducted by the Psychedelic Research Group at ICL, prior to the establishment of the CPR, was a study on the effects of LSD on brain activity, using brain imaging techniques.

MDMA

KEY TAKEAWAYS

  1. MDMA is not regarded as a classic psychedelic; it is classified as an empathogen. It produces none or fewer hallucinogenic effects than classic psychedelics. The potential for abuse in recreational use is also higher than with classical psychedelics.
  2. MDMA-assisted psychotherapy for the treatment of PTSD has completed the first part of phase III clinical trials. After receiving Breakthrough Therapy designation from the US FDA in 2017 it is expected to get final approval in 2023.
  3. It may then take up to six months after FDA approval for MDMA-assisted psychotherapy to be administered to the first patients. A real-world trial underway in Canada and other ‘compassionate use’ trials may give earlier access to a small number of patients.

MDMA (3,4-Methyl​enedioxy​methamphetamine, ecstasy) is a psychedelic that was first discovered in 1912, whilst finding a novel chemical route towards making another compound, by Merck. MDMA works primarily by increasing the availability of serotonin, dopamine and noradrenaline. A sense of general well-being and happiness, increased self-confidence, and increased empathy towards others are some of the subjective effects of MDMA. These effects are also what may facilitate psychotherapy efficacy.

Unlike with classical psychedelics, many recreational users experience a slump in their mood a few days after MDMA use. This negative side-effect has not been observed in clinical research where the dose is lower and patients are not dancing throughout the night; two factors that possibly contribute to the slump. Although most ecstasy tablets contain MDMA, it is not uncommon for them to contain adulterants. Similar to LSD, MDMA was used by therapists before it became illegal – particularly in couple therapy – and is still being used by underground practitioners to aid in the therapeutic process.

MDMA in the United Kingdom

Researchers from Imperial College London (ICL), some of which are also associated with Awakn Life Sciences, have published the first results of MDMA-assisted therapy for those with alcohol use disorder (AUD). The study was an open-label trial, meaning all patients knew they were getting MDMA, and involved two sessions with MDMA and then eight further therapy sessions. Patients went from drinking an average of 131 to 19 units of alcohol per week from before the study to one year after completion. Although there was no head-on comparison, other treatments for AUD rarely, if ever, find results of this magnitude.

Ketamine

KEY TAKEAWAYS

  1. Unlike other psychedelics, ketamine has been available as a medicine (general anaesthetic) for decades. For this reason, it is on the World Health Organisation’s List of Essential Medicines. It is also used as an ‘off-label’ treatment for depression, anxiety and suicidal ideation in ketamine-infusion therapy clinics.
  2. There has been a proliferation of ketamine infusion therapy clinics throughout the US and to a lesser extent in Europe. These clinics may well become a prototype in the market, occupying a prime position to take advantage of future expansion into psilocybin and MDMA assisted-therapy, when these substances receive FDA and EMA approval. The sector is relatively unregulated and ketamine infusion therapy is often not combined with talk therapy.
  3. Esketamine, a subtype of ketamine, in the form of a nasal spray (Spravato) has been patented by Johnson & Johnson and has been approved for the treatment of TRD with accompanying suicidal ideation. The costs of Spravato are significantly higher than that of ketamine which has led the UK’s National Institute for Health and Care Excellence (NICE) and Health Canada to not approve it as a medicine.
  4. Ketamine is one of the only psychedelic substances to be the focus of clinical trials in Asia. In China, specifically, clinical trials are focused on ketamine as an intervention, to study the impact of ketamine on health conditions such as postnatal depression, autism in children and arthritis.

Ketamine was first synthesised in 1956 and is used most commonly in veterinary practise as an animal tranquilliser. It is also a human anaesthetic and a powerful psychoactive substance and is available in liquid-soluble form as ketamine hydrochloride. Ketamine was granted US FDA approval for medical use as a general anaesthetic and sedative back in 1970 and has been classified as ‘safe to use’ as an anaesthetic because it does not reduce blood pressure or compromise a patient’s respiratory system. Ketamine may be injected into the muscle (IM), passed through an intravenous (IV) drip, taken orally, or absorbed via an oromucosal (nasal) spray.

Ketamine in the United Kingdom

In the UK, little research is taking place regarding the therapeutic potential of ketamine. In February 2020, the National Institute for Healthcare for Excellence (NICE) in the UK rejected the use of Spravato, based on efficacy and cost-effectiveness grounds. Despite this, Awakn Life Sciences has opened a ketamine-infusion clinic in Bristol. At this clinic, therapy is taking place under the supervision of Dr Ben Sessa, Chief Medical Officer at Awakn. The clinic offers a nine week course which comprises 11 psychotherapy sessions, four of which involve giving the patient a dose of ketamine at a costs of £6,000.

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