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.

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.

The European Citizens’ Initiative for Psychedelic-Assisted Therapies – launching at the start of 2025 – is aiming to collect one million signatures to urge the European Commission (EC) to take action on psychedelic-assisted therapies.

There are 150 million people in Europe living with a mental health condition, according to the World Health Organization (WHO). While there are treatments available, there has been no innovation in this area for over 50 years, and the treatments do not work for everyone.

For example, 10 to 30% of patients with major depressive disorder are resistant to currently available treatments, highlighting an urgent need for new therapies.

Adding to this, data from the Organisation for Economic Co-operation and Development (OECD) shows that mental health conditions cost the European economy up to €600 billion a year.

However, in recent years, increasing scientific research has shown psychedelic-assisted psychotherapy as an innovative and effective treatment for conditions such as depression, anxiety, addiction, and post-traumatic stress disorder (PTSD).

This mounting evidence has led to changes in policy and psychedelic access in countries such as Australia and Canada, where authorised patients are now able to access safe, legal psychedelic therapies.

Against this backdrop, the European Citizens’ Initiative for Psychedelic-Assisted Therapies has launched to urge the EC to support the future roll-out of psychedelic-assisted therapies in European healthcare systems.

The initiative is backed by 24 organisations, associations, researchers, therapists, patients, and citizens from 17 European countries, that are supporting the right of EU citizens to access affordable psychedelic-assisted therapies.

From 14 January 2025, the campaign will have one year to collect one million signatures from at least seven EU Member States in order to formally call for action from the EC. If the campaign collects the signatures successfully, the EC will have six months to respond to the initiative.

“With the launch in January begins a year-long campaign that can bring hope to millions of European citizens suffering from mental health problems,” commented Théo Giubilei, Founder of the PsychedeliCare Initiative.

Dr Rayyan Zafar, Chair of the recently launched Psychedelic Industry UK, which is also backing the initiative, commented: “On behalf of Psychedelic Industry UK, we welcome the launch of the First European Citizens’ Initiative for Psychedelic-Assisted Therapies, a pivotal step in addressing the growing mental health crisis in Europe.

“With the mental health burden rising across the continent and an increasing body of scientific research supporting the efficacy of psychedelic-assisted therapies (PAT), public support for this initiative is essential.

“Psychedelics, when used in a controlled, therapeutic setting, have shown remarkable potential in treating conditions such as depression, PTSD, addiction, anxiety, and other neuropsychiatric disorders which have reached epidemic proportions globally. However, regulatory barriers continue to limit their integration into modern healthcare.

“Public engagement can be a powerful catalyst for change, as we’ve seen in the UK with cannabis regulations. A groundswell of public support was instrumental in shifting political conceptions, leading to regulatory reform.

“A similar trajectory is possible for psychedelic therapies, but it requires broad public endorsement to pressure policymakers into action.

“This initiative presents an unparalleled opportunity for regulatory authorities to engage with the growing evidence base supporting psychedelic-assisted therapies. By doing so, we can develop a comprehensive regulatory framework that not only facilitates access to these treatments under medical supervision but also ensures the highest standards of safety and efficacy.

“We have witnessed the strides made in North America and Australia where medical and regulated access models for psychedelics are being developed and are in fruition. Europe must not be left behind.

“The time has come for our regulatory systems to reflect the scientific advancements in the field, many of which were discovered here, to improve patient access to life-changing therapies, and help tackle the escalating mental health crisis in Europe.

“This initiative is not just about signatures. It is about creating a movement that encourages policymakers to embrace innovation and evidence-based solutions in mental health care.

“I urge the public, professionals, and advocates across Europe to support this campaign.”

Organisations from across France, Croatia, the Netherlands, the Czech Republic, Italy, Portugal, Sweden, Greece, the United Kingdom, Ireland, Spain, Switzerland, Belgium, Estonia, and Poland are backing the campaign.

To find out more and to join the network, visit the official initiative website psychedelicare.eu.

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.