Connect with us

Research

The harms of psychedelics: separating anecdotes and misinformation

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

Published

on

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.

Find out what the decriminalisation of psychotropic substance cultivation means for the Right to Science

“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.”

To read the full paper please visit journals.sagepub.com/doi/full/10.1177/02698811211069100.

[activecampaign form=52]

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Research

Landmark UK trial to investigate psilocybin for opioid addiction relapse

Published

on

For the first time, a government-funded UK trial will investigate psilocybin-assisted psychotherapy for targetting relapses associated with opioid addiction, aiming to bring an innovative new therapy to the NHS if successful. 

Research shows that the UK had the world’s highest rate of opioid consumption in 2019, amounting to a serious public health concern. Further, figures show that around 140,000 people are accessing treatment for opioid dependence in the country. Despite the prevalence of opioid addiction, there are currently limited medicines to help prevent relapses during recovery.

Led by Imperial College London, the new study will use psilocybin combined with psychological support in people who have recently undergone detoxification from opioids such as heroin, methadone or buprenorphine.

While previous research into psilocybin has shown its potential as a treatment for conditions such as depression, anxiety PTSD and addiction, this is the first trial looking at the medicine for addiction relapse.

See also  Compass Pathways launches Phase 3 psilocybin trial in UK

The study is one of four projects focused on reducing drug deaths that have been funded by the National Institute for Health and Care Research (NIHR) as part of the Addiction Healthcare Goals programme, led by the Office for Life Science (OLS). 

According to the NHIR, the programme forms part of the Department of Health and Social Care’s plan to deliver a world-class treatment and recovery system for people experiencing drug and alcohol addictions.

Dr David Erritzoe, Clinical Director and Deputy Head of the Centre for Psychedelic Research at Imperial College London, project co-lead, said in a press statement: “We know that up to 90% of people relapse back to opioid use within 12 months of finishing detox, so finding new and effective treatments is essential. 

“If this trial is successful, it offers hope for a new type of treatment that could make a significant difference to this group of people.

“If our initial trial is successful, we will work to enable the development of further clinical trials in larger populations, to bring a new treatment to patients and the NHS.”

Participants will attend Imperial’s NIHR Clinical Research Facility at Hammersmith Hospital campus to receive psilocybin-assisted psychotherapy and will receive functional MRI brain scans to enable investigation of the mechanisms of psilocybin in the brain.

Imperial has confirmed that participants will be monitored for up to six months following dosing to track any changes to their opioid use, cravings, mental health outcomes and psychological wellbeing. 

Study co-lead Dr Louise Paterson said in a press statement: “This trial will examine whether we can improve recovery in a severely under-served group of people – namely, those with opioid dependence during their most vulnerable post-detox phase. 

“Clinical studies, including those in our Centre for Psychedelic Research, have shown great promise for this type of treatment in other mental health conditions. We want to see if it works equally well for opioid use disorder.”

Professor Anne Lingford-Hughes, Chair of the Addiction Healthcare Goals, and who is also a Professor of Addiction Biology at Imperial, added: “New approaches to treat drug addiction and reduce drug-related deaths, particularly from overdose, are urgently needed. 

“The Addiction Healthcare Goals programme is pleased to fund promising innovations that have brought together partnerships between industry, academia and organisations involved in delivering treatment and care for those experiencing drug addictions.” 

Recruitment is expected to begin in Spring 2025.

Continue Reading

Research

Psilocybin versus escitalopram for depression shows positive results

Published

on

Compass Pathways launches Phase 3 psilocybin trial in UK

A six-month follow-up study of a Phase 2 clinical trial investigating psilocybin versus escitalopram for the treatment of major depressive disorder has shown positive results.

Around 30% of people living with depression in the UK are resistant to current treatments, highlighting an urgent need for new therapies. As the researchers of this study highlight, even for patients who have had their depression successfully treated, there is a high risk of relapse, with one in three patients relapsing within the year.

Equally, SSRI treatments often include side effects such as sexual dysfunction, weight gain, fatigue, and emotional blunting.

The authors note that a key consideration of any treatment of major depressive disorder “is its capacity to produce sustained antidepressant response or remission.”

Mounting evidence is increasingly pointing to psilocybin-assisted therapy as an innovative new treatment for the condition, with clinical trials showing that the therapy is capable of producing rapid and long-lasting antidepressant effects.

However, while clinical trials have investigated the treatment itself, they have not compared the treatment to the current gold standard in depression medications or looked at the long-term effects of the treatment.

This Phase 2 trial is the first to compare the long-term antidepressant effects of these two treatments alongside mental health measures including work and social functioning, connectedness, and meaning in life. 

In the trial, patients with major depressive disorder recruited from a UK hospital were administered either two doses of 25mg of psilocybin along with psychological support, or a six-week course of the selective serotonin reuptake inhibitor (SSRI) escitalopram in combination with psychological support.

The findings, published in eClinicalMedicine, revealed that both administered treatments saw sustained improvements in depressive symptoms, however, patients who were administered psilocybin-assisted psychotherapy saw greater lasting improvements. 

These improvements included psychosocial functioning, meaning in life, and psychological connectedness.

Dr James Rucker, Consultant Psychiatrist & Senior Clinical Lecturer in Psychopharmacology, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, said: “The authors have tended to attribute differences observed in this study to comparative differences between the drugs themselves, however, it is also possible that the results reflect biased reporting between groups. 

“This is more likely here because A) studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and B) study participants were unblinded during the long-term follow-up phase that is reported in the paper, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. 

“The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe and the US.”

The authors write: “Key limitations of the study include its suboptimal power to detect small but meaningful differences between treatments, missing data, the potential use of additional interventions during the follow-up period, and reliance on self-reported treatment assessments. 

“These factors may affect the interpretation of the study findings and should be considered when evaluating the results.”

With these considerations in mind, the researchers suggest that the findings warrant further investigation into psilocybin-assisted psychotherapy for the treatment of depression.

Continue Reading

Research

Shortwave Life Sciences psilocybin drug shows positive results in anorexia trial

Published

on

Shortwave Life Sciences psilocybin drug positive results anorexia trial

Shortwave Life Sciences has announced it has achieved a significant breakthrough in its ambitions to transform eating disorder care with positive pre-clinical results from its latest pharmacodynamics study, demonstrating the safety of its psilocybin-based drug combination for the treatment of anorexia nervosa.

Anorexia nervosa has one of the highest fatality rates. The condition is a complex mental health condition as well as a metabolic disease, yet no FDA-approved pharmacological treatments are currently available for the condition.

Shortwave Life Sciences in collaboration with Science in Action, an expert pre-clinical GLP-certified lab in Israel, has now tested the safety of buccal administration of Shortwave’s combination drug comprised of psilocybin and a beta-carboline.

The company says this novel treatment provides an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain.

For the study, three groups of rats were given varying doses of the combination drug (0.23ml, 0.5ml, and 1ml), with results showing no adverse effects, weight changes, or behavioural changes following the psychedelic effects.

See also  Short Wave Pharma: innovating eating disorder care with psychedelics

“This is a monumental step forward for Shortwave. Our relentless pursuit of breakthrough mental health treatments comes with the responsibility of ensuring safety at every stage,” commented Shortwave Life Sciences CEO Rivki Stern Youdkevich.

“We are proud of the positive outcomes from this rigorous pre-clinical trial, further validating our patent-pending drug combination and buccal delivery system.

“With this success, we are reaffirmed in our approach to addressing the global mental health crisis.”

In the pre-clinical pharmacodynamics study, all subjects remained healthy and unaffected during the trial, which Shortwave has stated marks a strong foundation for future clinical development.

Furthermore, no adverse events or vital sign changes were reported across all groups, and the results confirmed the safety profile for the psilocybin-based combination drug at elevated doses.

This achievement comes on the heels of the International PCT Examining Committee’s recent acknowledgment of Shortwave’s patent claims for its novel, non-obvious, and industrially applicable mucoadhesive buccal film.

Designed for rapid absorption and bypassing liver and gut degradation, the platform holds transformative potential for patients facing metabolic and psychiatric challenges. This method of administration is designed to be sensitive to patient needs, who may not want to swallow the medicine, and also provides higher bioavailability.

Continue Reading

Trending

Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

Copyright © 2023 Psych Capital Plc