A series of clinical trials studying the effects of psychedelics on severe mental health conditions has been launched in the East of England.
People across Cambridgeshire and Peterborough with treatment-resistant mental health disorders now have the opportunity to participate in research trials using psychedelic compounds and neuroplastogens.
The newly formed Cambridge Psychedelic Research Group is the first in the East Anglian region to offer studies investigating the potential of psychedelics to support those with conditions that have not responded to conventional treatments.
The initiative is a result of a partnership between the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust (CUH) and Cambridgeshire and Peterborough NHS Foundation Trust (CPFT).
CPFT consultant psychiatrist and principal investigator Dr Liliana Galindo said: “We are excited to join the growing psychedelic research field with this new local partnership and help to develop the next wave of neuropsychiatric treatments. There is great potential to treat persistent mental health conditions that are resistant to standard therapies."
Traditional treatments for mental health issues, such as therapy and antidepressants, do not work effectively for approximately 30% of people with severe mental illness.
Recent studies have shown that certain psychoactive substances, when used under clinical supervision, can help improve the quality of life for those with treatment-resistant conditions.
The Cambridge Psychedelic Research group is now conducting its first major study. Sponsored by Transcend Therapeutics, the IMPACT-1 trial focuses on the effects of the fast-acting neuroplastogen TSND-201 on individuals with post-traumatic stress disorder (PTSD).
TSND-201 is a non-hallucinogenic drug designed to promote neuroplasticity — the brain’s ability to regrow and reform lost neural connections. This process is thought to play a crucial role in recovering from conditions such as PTSD.
Current treatments for PTSD — including talking therapies and antidepressant medications — do not work for everyone, which has led to the exploration of alternative treatment methods.
To ensure the safe and legal use of psychedelics in clinical settings, research centres must meet strict licensing requirements.
The Cambridge Psychedelic Research Group secured a licence from the Home Office, enabling researchers to administer experimental therapies in a controlled clinical environment. This approval allows the administration of psychedelics in a manner that aligns with UK government regulations on clinical practice and safety.
Dr Galindo added: “Thank you to everyone in Cambridge who has worked so hard to meet the rigorous standards to achieve our licence and set up our very first study to help people with PTSD.
"Our expert researchers and clinicians can contribute a great deal to the global evidence base and we will be trialling new mental health treatments that could help millions.”
An estimated one in ten people in the UK will experience PTSD at some point in their lives. The condition can result in symptoms such as flashbacks, nightmares and hypervigilance, often severely impacting an individual’s daily life.
TSND-201 offers a potential alternative for those who have not found relief through traditional means.
The research team is currently seeking participants with PTSD for whom standard treatments have been ineffective. Eligible participants will receive either TSND-201 or a placebo once a week for four weeks. They will be monitored for an additional six weeks following the trial to assess the treatment’s impact.
One of the first participants in the IMPACT-1 study said: “Having lived with PTSD since my tour in Iraq in 2007, I’ve been seeking out any new treatments available. I was excited to see this study being conducted by my local NHS nearby, and this study seemed to be the best option for me, as I could potentially expect to feel results in days, not months.
"Although I was hesitant about other drug trials with psychedelics, it set me at ease that the compound being tested was not a psychedelic and could be safely administered through this NHS clinical trial. Everyone involved has exceeded my expectations and I have so many military friends that will benefit from this research.”
The Cambridge Psychedelic Research Group is already in the approval stages for its next clinical trial, which will explore the use of psilocybin for mental health treatment. The study could begin later this year, adding to the growing body of research supporting the use of psychedelics in therapeutic settings.
Head of Pharmacy Clinical Trials Services at CUH Lynne Whitehead added: “The CUH pharmacy team are delighted to be able to support research into new drug treatments for this therapeutic area and contribute to building the evidence base required.”
Those interested in participating in the TSND-201 trial are encouraged to visit the IMPACT-1 website for more information. The trial is not recruiting volunteers who do not have mental health conditions.