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The harms of psychedelics: separating anecdotes and misinformation

Classic psychedelics fall into the lowest-risk category for drugs, say experts.



Phase 2 LSD for major depression trial shows positive topline data

A new narrative review of systematic evidence has been published by leading researchers at Drug Science to get the facts on the adverse effects of classic psychedelics.

Classic psychedelics fall into the lowest risk category for drugs, the review findings show. This means they are non-toxic to the human body and have a very low dependence rate.

Published by non-profit organisation Drug Science in the Journal of Psychopharmacology, the paper highlights that policy has yet to catch up with the science – attributed largely to misinformation.

The authors focus on classic psychedelic compounds – serotonergic psychedelics such as psilocybin, DMT, ayahuasca, mescaline and LSD. 

Authors include Dr Katrin Anne Schlag of Imperial College London and King’s College London, Jacob Aday of Central Michigan University and the University of California, Davis, Iram Salam, Professor Jo Neil of the University of Manchester, UK and Professor David Nutt of Imperial College London.

An unwarranted reputation 

Decades of anecdotes have given psychedelic substances a reputation for being dangerous. Sensationalist reports of people losing their minds, getting hallucinogenic flashbacks or jumping off buildings have contributed to negative public attitudes towards these compounds.

In recent years, despite costly regulatory barriers, scientists at institutes such as Imperial College London, Harvard University, Johns Hopkins and many more, have been able to look more closely at them – revealing strong therapeutic potential in the areas of mental health and addiction.

Speaking to Psychedelic Health, paper co-author Dr Anne Katrin Schlag, head of research Drug Science, department of brain science, Imperial College London, and department of geography, King’s College London, commented: “Psychedelics previously received quite a bad reputation within the media and within the public domain, unreservedly so.

“One concern that people tend to have is that they are addictive and you can become dependent on them. Their scheduling as Class A together with heroin and cocaine would suggest this, but this is not based on scientific evidence.

“However, with the recent research, especially the past decade, and media reports of people who have actually have been helped and healed by various types of psychedelics, it seems there is now a move towards a more favourable attitude towards these substances From the public, as well as politicians, doctors and potential prescribers who are looking at the research in-depth.

“In our review, we are presenting the scientific evidence of various harms and look in detail at which of these are supported by the current science, and which are merely based on previous myths and negative perceptions.

“These substances are not new, and they have been studied before.”

See also  Findings give new insight into how psychedelics help mental health

The counterculture movement in the 60s saw an explosion of cultural liberation and experimentation with fashion, music and drugs. Prominent figures including Ken Kesey, Allen Ginsberg, Timothy Leary, Richard Alpert and Aldous Huxley – as well as popular musicians such as Jim Morrison, Jimi Hendrix, Gerry Garcia and Janis Joplin – were all experimenting with LSD.

Frequent reports of their use led to the perception that the compounds had a high dependence rate. In 1971 Nixon declared the worldwide “war on drugs”, labeling drug abuse as “America’s public enemy number one”. The same year, psychedelics were scheduled in the highest category of the UN Convention on Psychotropic Substances. 

By this time there was a large body of research into the use of LSD in humans, reporting largely positive effects but with significant shortcomings. The paper highlights: “The emergence of 1960s counterculture, led to a media frenzy and sensationalised representations of these substances, contributing to the halt of promising scientific research and national and international [under the 1971 UN Conventions] bans on LSD”.

Schlag commented: “Before Nixon declared the war on drugs there was quite a lot of promising research with psychedelics such as LSD, but due to their increasingly bad reputation within the counterculture movement, and sometimes not sufficiently high ethical research standards, this research came to a standstill.

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“We found some of this earlier research, in addition to the current research, and looked at it in detail, to actually find that there were few medical risks reported – and there were thousands of patients during that period of time as well.

“All drugs or substances – legal or illegal – have risks but we do know that if you look at the medical risks, such as toxicology, neurotoxicity, hypertension, cardiovascular disease, classic psychedelics consistently rank very low in comparison to other substances.

“When there are issues, these tend to be resolved very quickly – within the session usually – and are transient.

“The potential for addiction is very low as well. Some of these substances have now been shown to be anti-addictive and could actually help people with addiction very substantially.”

Psychedelics are undeserving of their current scheduling

Timothy Leary, Richard Alpert and Ralph Metzner’s work, The Psychedelic Experience, based largely on the Tibetan Book of the Dead, emphasises “set and setting” as fundamental to the positive psychedelic experience. 

The new paper echoes this importance for clinical outcomes when using these compounds: “Looking at differences between clinical vs non-clinical uses and users, we stress that whilst these categories are blurred and use and users might be overlapping between categories, notable differences can be discerned in users’ set and setting, as well as the pre- and aftercare experienced – both areas where above adverse effects are potentially exacerbated.”

Schlag et al highlight some of the common challenging experiences induced by classic psychedelics are “bad trips”, but these are quite rare and “are often found to be extremely cathartic”.

See also  Global coalition launches to push for psilocybin rescheduling 

“When we are looking at medical uses of psychedelics in a clinical environment – in a safe setting, under supervision, where the patient is fully supported before, during, and after the session with integration by a fully trained psychiatrist or therapist – then these adverse effects are extremely rare,” said Schlag.

“What has also been shown globally now with the multi-criteria decision analysis work that Drug Science is doing, which was first published in The Lancet in 2010, they consistently rank very low. 

“Especially for magic mushrooms – classic psychedelics are undeserving of their current scheduling. We have done multi-criteria analysis regularly to analyse the harms of drugs, and not just the individual health harms and physiological harms, but also the societal harms and the harms to others.”

More research is needed

The authors conclude that it is vital that clinicians and therapists keep to the highest safety and ethical standards and that balanced media reporting is also key in “avoiding future controversies, so that much needed research can continue”.

Schlag said: “We need more research to be funded and to reschedule psychedelics so that the research can actually happen easier and become less costly. I think we have only just started to see their potential, but this has to be done extremely carefully in a regulated environment.

“People reading about it and taking a psychedelic to heal their PTSD, for example, could potentially be very damaging if they are in an unsafe environment because these are very strong drugs – they need to be administered and taken in a safe set and setting.

“However, that is not to say that there’s no room for non-clinical applications, because a lot of these plant medicines have been used for millennia, very successfully, within various cultures.

“I think we are really very much at a crossroads – psychedelics will be able to help a lot of people but we have to be cautious, because a lot of these people are also very ill and need to be treated correctly within the medical – or otherwise safe – environment.

“At the moment, the main issue is that’s not really possible because our Western society does not allow access to these medicines.”

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Psilocybin analogue shows positive results in Phase 2 depression study



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.”

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



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



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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