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First-of-its-kind study to investigate the evolution of psilocybin

A team at the University of Plymouth will be focusing on the role of psilocybin in nature.

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Using psilocybin in natural settings shows lasting results
Photo by Tania Malréchauffé on Unsplash

An increasing amount of research is investigating the efficacy of psychedelic mushrooms for the treatment of a number of health conditions, however, knowledge about how psychedelic compounds have evolved and their role in the natural world is limited.

To understand more about this, Scientists from the University of Plymouth are conducting a study that will harness advanced genetic methods and behavioural experiments to address previously untested hypotheses about the origin of psychedelic compounds in fungi.

This includes exploring whether such traits have evolved as a form of defence against fungus-feeding invertebrates, or whether the fungi produce compounds that manipulate insect behaviour for their own advantage.

The study is being led by a team of experienced researchers in molecular ecology, animal-plant interactions and fungal biology in the University’s School of Biological and Marine Sciences. Driving the study are Post-Doctoral Research Fellow Dr Kirsty Matthews Nicholass and Research Assistant Ms Ilona Flis.

Testing hypotheses 

The main focus will be on psilocybin. The researchers are sampling psychedelic and non-psychedelic fungi, and using next-generation DNA sequencing to test whether or not there is a diverse animal community feeding on psychedelic fungi.

Study supervisor, Dr Jon Ellis, Lecturer in Conservation Genetics, commented: “In recent years, there has been a resurgence of interest in psychedelic compounds from a human health perspective. However, almost nothing is known about the evolution of these compounds in nature and why fungi should contain neurotransmitter-like compounds is unresolved.

“The hypotheses that have been suggested for their evolution have never been formally tested, and that is what makes our project so ambitious and novel. 

See also  Australian patients can now access psilocybin and MDMA

“It could also in future lead to exciting future discoveries, as the development of novel compounds that could be used as fungicides, pesticides, pharmaceuticals and antibiotics is likely to arise from ‘blue-sky’ research investigating fungal defence.”

The team will be using laboratory tests to investigate fungal-insect interactions, and whether the fungi undergo genetic changes during attack and development, as well as the effect of psilocybin on the growth of soil bacteria.

Additionally, cutting-edge gene editing technology will be used to try and create mutant fungi that cannot synthesize psilocybin. It is hoped this will help researchers better understand the role of a wide range of fungal compounds in future.

Matthews Nicholass said: “Within Psilocybe alone, there are close to 150 hallucinogenic species distributed across all continents except Antarctica. 

“Yet, the fungal species in which these ‘magic’ compounds occur are not always closely related. This raises interesting questions regarding the ecological pressures that may be acting to maintain the biosynthesis pathway for psilocybin.”

Legislation has impeded research

Researchers involved in this project have previously explored the genetic diversity among UK pollinators, the feeding preferences of slugs and snails, and developed an early warning system for plant disease.

Ellis highlights that research into psychedelic fungal compounds has been inhibited through restrictive legislation.

Ellis commented: “Fungi generally receive less attention overall than animals and plants, partly because they are less apparent, people interact with them less and they can be hard to study. 

“Historically, there have also been legal barriers which meant certain research has not previously been possible. Saying that, there were some very interesting studies in the 1940s and 50s into the use of LSD as a psychotherapeutic treatment for alcoholism and obsessive-compulsive disorder. Around that time, people also became interested in fungi from an anthropological perspective.

See also  Are there interactions between psychedelics and psychiatric treatments?

“One couple, the Wassons, went to Mexico and witnessed the ritual use of fungi for the first time in religious ceremonies. Articles they published brought public attention to psychoactive mushrooms. 

“Around this time, there were also other charismatic individuals, such as Timothy Leary, who advocated the use of LSD more widely by the general public. In the 1960s, psychedelic compounds really came to widespread public attention and that ultimately led to governments introducing new laws to restrict their use.

“For some time, that also restricted the fundamental research that could be carried out. More recently, people have returned to that initial research and found that compounds such as psilocybin can have psychotherapeutic benefits. However, that has not addressed their evolution in nature, which is what makes the research we are doing so exciting.

“I hope our project can change the public perception of magic mushrooms. But beyond that, asking questions about the biological world is a fundamental part of our human nature and this project fits into a long narrative of research asking questions about biodiversity and its evolution.”

The research is being funded by the Leverhulme Trust and builds on the University’s long-running expertise in novel elements of conservation genetics.

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Psilocybin analogue shows positive results in Phase 2 depression study

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Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

See also  First MDMA administration in PTSD trial completed

Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

See also  Clerkenwell Health is launching a free UK psychedelic therapist training programme

Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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Paper explores extended difficulties following psychedelic trips

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Paper explores extended difficulties following psychedelic trips

A new paper has explored the extended difficulties experienced by some people following psychedelic drug use and discusses psychedelic harm reduction.

While multiple studies have shown that psychedelics can be safe when administered appropriately, some people experience difficulties following their use. These difficulties can last anywhere from a few days to years.

With a rise in clinical research surrounding these compounds, there is a drive to change drug policy and several places have already implemented progressive approaches to accessing these therapies such as decriminalisation or including them on authorised medical access schemes. 

In light of these developments, it is vital to understand the potential risks associated with psychedelic use and what actions can be taken to reduce these risks.

The paper has been published in Plos One and authored by a team of leading psychedelic scientists from the Universities of Exeter, Greenwich and Queen Mary, University College London and Royal Holloway, New York University and the Perception Restoration Foundation.

Extended difficulties following psychedelic use

The team of researchers has gathered data on the context of use, nature and duration of these difficulties and explored risk factors and perceived causes that may contribute to these experiences. 

The most common forms of extended difficulty that the team uncovered include symptoms such as anxiety/fear and existential struggle, as well as social disconnection, depersonalisation and derealisation.

“For approximately one-third of the participants, problems persisted for over a year, and for a sixth, they endured for more than three years,” the authors write.

The findings revealed that the length of time these experiences last following psychedelic use could be predicted by the participants’ knowledge of dose and drug type, and that the experiences were shorter if a participant had taken part in a guided psychedelic experience. 

Additionally, the most common length of time such difficulties lasted was between one and three years. When asked about mental illness onset following the psychedelic experience, 18.8% said they had gone on to be diagnosed with a mental illness, while 76.8% said they had not.

The authors write: “Our findings support the results of Simonsson et al., who found that anxiety was the most common enduring difficulty, based on quantitative questionnaire data and Bouso et al’s study of the Global Ayahuasca Survey, in which ‘feeling nervous, anxious or on edge’ was the second most common adverse mental health effect. Our findings also suggest that a Sense of disconnection from others was within the top five most prevalent themes, as did the studies by Simonsson et al. and Bouso et al. 

“Some extended adverse effects that were quite common in other studies weren’t so common in our data set–for example, feeling a harmful connection to the spirit world was reported by 14% of respondents to the Global Ayahuasca Survey but by less than 4% of our data set, which may suggest some forms of difficulty are particularly associated with certain psychedelic substances and/or their associated cultures.”

Reducing risk factors

The authors suggest a number of actions that could be taken to reduce these risks.

Highlighting that, as anxiety and fear are some of the most commonly reported difficulties, the authors suggest that all legal psychedelic experience providers give guidance on methods for “self-soothing and overcoming bouts of anxiety following the retreat, clinical trial or ceremony.”

Further suggestions include informing participants of potential harms and risks and advising participants that the integration process may take some time, and what practices can be done to help people cope with difficulties. The authors say these practices will be explored in an upcoming paper.

The team writes: “We envisage using the information in this study, and accompanying future papers that focus on social support and forms of coping used by those with enduring difficulties, to provide structured guidance and training to psychedelic retreats, therapists and clinical trial centers about the potential for adverse experiences, what the potential risk factors are and what can be done to help individuals who report such extended difficulties.”

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