This news release presents the latest vital policy and scientific developments in the field of psychedelic therapies. Notably, for the first time, the UN and the European Monitoring Centre for Drugs and Drug Addiction have included chapters on psychedelics in their reports. In addition, the U.S. Food and Drug Administration has released its first guidelines on this subject. A recent paper in Nature also discussed the potential for psychedelics to reopen critical periods of brain development, a possibility that could have far-reaching implications.

Global interest and regulatory challenges: UN's World Drug Report 2023

The UN has released the World Drug Report 2023. An 11-page chapter is dedicated to "Recent developments involving psychedelics," signifying the growing global interest in this area.

The report highlights the rapid growth of psychedelic research, calling the pace "unprecedented." This surge is expected to have extensive effects on treating various mental health conditions, contingent on evolving regulatory frameworks.

The report also emphasizes potential risks. As the perception of psychedelics as remedies for mental health disorders outpaces the accumulation of scientific evidence, concerns arise around unsupervised self-medication and recreational use before establishing supervised therapeutic use.

Another challenge is the need for supervised medical treatment paired with psychotherapy, which necessitates substantial resources, including trained professionals and infrastructure. This requirement may limit accessibility, potentially leading to an unregulated, underground market for these therapies and an increased risk of misuse and abuse.

Importantly, the report ranks psychedelics lower in terms of "abuse liability and dependence potential" compared to substances like opioids, psychostimulants, cannabis, or alcohol.

The report states that, by February 2023, there were 450 registered clinical studies exploring the therapeutic effects of psychedelics. A list of conditions for which clinical trials are proposed or ongoing includes the following: depression, bipolar disorder, anxiety (especially in patients with terminal illnesses such as cancer), PTSD, obsessive-compulsive disorder (OCD), eating disorders, cluster headaches, migraines, Alzheimer's disease, Parkinson's disease, post treatment Lyme disease, treatment of alcohol, tobacco, methamphetamine, cocaine, cannabis, and opioid use disorders, depression and anxiety in Parkinson's disease, chronic pain, ADHD, autism spectrum disorder, obesity, mood disorder, suicidal ideation, epilepsy, acute and chronic pain.

Psychedelics in Europe:
the EMCDDA report 2023

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) presented its latest analysis of Europe's drug situation in the European Drug Report 2023: Trends and Developments.

The report observes increasing clinical and public interest in the therapeutic use of psychedelic substances, and dissociative drugs like ketamine. Numerous clinical studies are exploring these substances' potential in treating diverse mental health conditions. While the research is still nascent and making broad conclusions is difficult, the initial findings are promising.

The report also underscores associated risks. Extensive media coverage could inadvertently encourage uncontrolled use of these substances, potentially exposing vulnerable individuals to adverse effects. Moreover, there are indications of unregulated programmes operating within the EU and globally, integrating the use of psychedelic substances within wellness, therapeutic, or spiritually oriented interventions. The report underlines the need for robust regulations and clear guidelines to ensure safe and efficacious use of these substances.

FDA guidelines: a step forward
for psychedelic medicines

The US Food and Drug Administration (FDA) has released new guidelines titled "Psychedelic Drugs: Considerations for Clinical Investigations" to assist sponsors developing psychedelic drugs for treating medical conditions, such as psychiatric disorders and substance use disorders. The guidelines acknowledge the unique challenges of designing clinical studies for these compounds due to their intense perceptual disturbances, alterations in consciousness, and hypothesized rapid-onset and long-term benefits.

The document provides foundational constructs for all sponsors studying the therapeutic potential of psychedelic drugs to ensure ethically conducted clinical trials, preserving the trial's integrity and the reliability of results. The guidance thoroughly details considerations for researchers during the drug development process, including trial conduct, data collection, participant safety, and new drug application requirements.

Tiffany Farchione, director of the division of psychiatry at the FDA's Center for Drug Evaluation and Research, emphasized that the goal is to assist researchers in designing studies that yield interpretable results to support future drug applications. Additionally, the guidance underscores the potential for safety issues and abuse, given that psychedelic substances can induce mood and cognitive changes or hallucinations.

The Nature paper: psychedelics and
the reopening of critical periods

A recent study published in Nature, titled "Psychedelics Reopen the Social Reward Learning Critical Period" has shed new light on the potential therapeutic benefits of psychedelics.

The study's findings build upon the theory of critical periods, first proposed by Konrad Lorenz in 1935. Critical periods refer to specific time frames during which an organism is particularly susceptible to certain types of learning or behaviour. The Nature paper suggests that psychedelics may have the potential to reopen these critical periods, thereby enhancing psychological flexibility and cognitive reappraisal.

The paper posits that all psychedelics tap into molecular mechanisms conserved across all types of critical periods, unveiling a neural substrate that underlies the ability of psychedelics to induce psychological and physiological flexibility. This could potentially make psychedelics a 'master key' for unlocking a broad range of critical periods, including those related to visual or motor functions, e.g., after a stroke. As such, psychedelics could be paired with other molecules that have shown promise in earlier studies, such as those related to autism, thereby reopening the critical period and allowing for more effective treatment.

Furthermore, the research delves into the potential correlation between the duration of psychedelic subjective effects and the length of the critical period. For instance, psilocybin, with subjective effects lasting 3-6 hours, corresponds to a critical period of two weeks, while LSD, lasting 8-10 hours, corresponds to about three weeks.

If these findings are further substantiated, they could have profound implications for the treatment of various brain conditions, particularly in adults, whose brains are not as malleable as during childhood. This groundbreaking research opens up new avenues for understanding and potentially treating a range of neurological and psychological conditions.