Psych News - September 2025

There have been some key developments throughout the psychedelic industry over the past couple of weeks. Findings include a large-scale review providing some concerning evidence that high-concentration THC cannabis is linked to adverse mental health outcomes. Separate research has backed this up, indicating that self-medicating with cannabis can, in fact, exacerbate paranoia.

In the psychedelic therapy space, new studies are exploring the potential of LSD to tackle issues with anxiety. Also, we explore the use of non-drug alternatives like breathwork to promote similar states to those created by psychedelics, as well as the development of non-hallucinogenic psychedelics being pioneered in the treatment of chronic inflammation. We will discuss further developments in the FDA decision on MDMA-assisted therapy and the response to it from the wider community. Finally, some positive market projections relating to companies in the psychedelic space, and a strange emerging trend in which people are using AI chatbots as trip sitters, providing psychedelic guidance.

Cannabis and Mental Health

A comprehensive review of almost 100 studies has raised definite concerns with the health impacts of high-potency, high-THC cannabis products. Researchers found strong correlations between THC use and conditions such as psychosis, schizophrenia, and cannabis use disorder. Results for anxiety and depression, however, were inconclusive and contradictory.

Researchers from the University of Colorado Anschutz Medical Campus and colleagues reviewed 99 studies, consisting of 221,097 participants, and carried out between 1977 and 2023. The selection criteria were broad, attempting to encompass as much data as possible, regardless of whether the studies themselves were geared towards mental health or potential therapeutic effects. High-concentration cannabis products were defined as those with over 5 mg, or 10% THC per serving, as well as concentrates with extremely high potency, like shatter or dabs.

While the research provided a huge amount of data, researchers were unable to conclude categorically that higher concentrations of THC increase the regularity of adverse mental health outcomes. This means that, although the strong correlations on display here definitely suggest there are likely to be links and risks, we are not yet in a position to provide clear clinical guidance on this.

Cannabis Self-Medication and Paranoia

In further troubling news surrounding cannabis usage, new research is revealing that people who use cannabis to self-medicate a variety of conditions are more likely to experience paranoia. This is also accompanied by an increase in THC usage, which in turn results in more paranoia, a vicious cycle. Childhood trauma worsens these outcomes, especially emotional abuse, which is strongly correlated with individuals experiencing unmanageable paranoia.

Two studies using data from the Cannabis & Me survey, one from Cambridge University, the other published in BMJ Mental Health, found that using cannabis as a long-term solution to mental health ills may be counterintuitive and, in fact, have a lasting negative impact.

LSD to Treat Anxiety

Between 1950 and 1965, around 40,000 patients were prescribed lysergic acid to treat conditions as diverse as alcoholism, schizophrenia, and PTSD. Subsequent legislation and cultural demonisation removed LSD from the psychiatric world until more recently. However, an increasing number of studies are now showing LSD’s potential. Recently published research has revealed that LSD can promote significant reductions in a variety of psychiatric symptoms, including anxiety and depression. These improvements were seen to persist for 16 weeks following the final treatment. The study also found a correlation between the effectiveness of the treatment and the reports from participants of greater feelings of oneness with the world, or mystical/transcendent experiences.

While the study was limited in scale, it does provide further evidence that LSD-assisted treatment has some potential. As a final point, while the study does not specifically reference it, the correlation between perceived importance/extremity of the experience does perhaps throw some doubt as to the effectiveness of microdosing smaller amounts of a substance for similar reasons.

Psychedelic Breathwork

For millennia, tribal rituals and other religious/spiritual practices have employed breathwork to access altered states of consciousness. A study led by Amy Amla Kartar from the Brighton and Sussex Medical School has now provided some concrete, scientific grounding for these widely understood effects. Kartar aimed to investigate the actual impact on the brain of the practice. Participants in the study were monitored during 20-30 minute breathwork sessions, accompanied by a variety of music at varying intensities. The study utilised both self-report and MRI scans to get a comprehensive understanding of the subjective experience as well as any specific alterations to brain function.

Breathwork not only induced the experience of “oceanic boundlessness” first described by Sigmund Freud: the well-known subjective feeling of oneness and connection with the universe. This was accompanied by changes to the function of specific brain regions involved in self-awareness and emotional processing. These changes to brain function were witnessed regardless of whether or not the body’s stress response had been triggered.

This provides some potentially exciting non-pharmacological means for therapeutic intervention in conditions which are often distressing and powerfully limiting. There may, of course, be initial issues with scaling the potential therapy due to the need for direct support and monitoring throughout. However, this scaling problem is identical for the use of traditional psychedelics in hallucinatory dose ranges.

Anti-Inflammatory Properties of Psychedelics Derived Compounds

Professor Nicholas Barnes at the University of Birmingham is leading work to establish whether psychedelic adjacent drugs can be harnessed to tackle neurodegenerative diseases like Alzheimer's and Parkinson’s. The research is centred on the use of new compounds derived from psychedelics, designed to avoid any conscious altering activity. These compounds, “PIPI drugs”, are Psychedelic drug Informed but Psychedelic-experience Inactive.

Traditional psychedelics have been shown to have anti-inflammatory effects. PIPI drugs attempt to avoid all hallucinogenic effects while maintaining their potential benefits – particularly important when tackling degenerative brain conditions, as psychedelic effects may be unmanageable.

The research, published in the British Journal of Pharmacology, highlights that the anti-inflammatory effects may well be separate from their hallucinogenic effects, potentially allowing researchers to isolate what it is in the substances that is responsible for each effect. Psychedelics' consciousness/visual altering effects are known to stem from their impact on the 5-HT2A receptor, which is not only found in brain cells, but also in immune cells. Influencing these cells specifically could be the key to capturing the anti-inflammatory properties. The difficulty here would be specifically targeting immune cells. Aside from the challenges, this research holds the potential to promote a new class of chemicals for safe, targeted therapies for many chronic conditions.

Fallout from FDA Rejection of Lykos Therapeutics

The FDA has released the specifics of their rejection letter to Lykos Therapeutics’ MDMA-assisted therapy trial. The letter outlines several key reasons for its decision not to approve the potential therapy:

Inadequate Safety Data

The FDA found that Lykos failed to adequately collect and report data relating to important information on the specifics of events described as “positive” or “negative”. This data is necessary to assess both the impairment of an individual as a result of the therapy, as well as the addiction potential of the substance employed – in this case, MDMA. The FDA also expressed some concern that there had been cases of unreported negative outcomes or adverse reactions at some study sites.Lack of Durability Data

The FDA determined that the application did not provide enough evidence to support their conclusion that the treatment remained effective following the 18-week assessment period of the study itself. The FDA also criticised the format of the follow-up study to form these conclusions. Variability in follow-up timing, the fact that it consisted of a single visit with no control of, or seeming interest in, any self-medication by participants in the meantime. Potential for Bias

Approximately 40% of trial participants had already had experience using MDMA in a recreational context. This is a far higher rate than seen in the wider population of individuals suffering from PTSD. This, combined with high rates of failures when pre-screening participants, suggests potential issues with selection bias. This could limit the applicability of the study to individuals as a whole, rather than those already familiar with the drug’s effects.The FDA has not outright rejected the study, but rather recommended means to remedy these perceived issues. They suggest Lykos conduct a new, randomised, double-blind clinical trial to assess the durability of the effects they studied as well as the safety profile of the substance administered. They also recommended an independent third-party audit of all the findings thus far, to assess whether or not they are, in fact, valid or representative.

Lykos Therapeutics expressed its disappointment with the decision, announcing its desire to meet with the FDA and appeal the decision. Lykos believes that the FDA’s concerns can be alleviated using the already existing data or with reference to other already existing scientific data. The delay caused by the necessity for a mult-year Phase 3 study could prove catastrophic to the viability of continuing research. Lykos also cited worries with the approval process itself, due to the perceived lack of experts in the subject matter present on the panel.

Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), now Lykos, has expressed dissatisfaction with the decision, claiming the FDA has “moved the goalposts”. Doblin says that the FDA’s concerns with the continued durability of the substance following treatment have not been a standard used to approve drugs previously, like those approved for use in cancer treatment, where relapses are common, for example. Doblin also explained that while Lykos had in fact submitted an amendment to their application to respond to the advisory committee’s concerns, the FDA did not take this into account when rejecting the study. Doblin did, however, praise the full release of the rejection letter, allowing for wider, constructive debate, with the hope Lykos may be able to push ahead following further discussion.

Growth in the Global Psychedelics Market

The global psychedelics market is predicted to top 10.11 billion USD by 2032, continuing to grow rapidly at a rate of 13.68% from 2025 to 2032. The market was valued at just 3.63 billion USD in 2024, illustrating the rapidity of the growth. The psychedelic renaissance continues apace! This growth is being driven by increasing research efforts, relaxing legislation, and the fact that mental health has become increasingly recognised as a public health priority – due to its sheer ubiquity. Synthetic compounds like ketamine and MDMA are currently the market leaders, holding around 55% market share. The Asia-Pacific region is projected to have the highest global growth rate in the coming years.

AI as Tripsitter

A growing trend is seeing solitary users of psychedelics turning to AI chatbots like ChatGPT to act as trip sitters, or guides throughout their experiences. This trend is likely driven by a large and increasing demand for psychedelic experiences, both therapeutic and recreational, combined with the expense of a session with a licensed facilitator. This could cost thousands of dollars. Chatbots can be completely free of charge or low-cost. Experts are warning of potential dangers here, especially with the well-known phenomenon of AI hallucination. The large language models (LLMs), which chatbots are built upon, are effectively very complex versions of autocorrect on your phone keyboard; they predict the most likely words following from a user’s query, as opposed to actually thinking or understanding what has been said. To be completely clear here, ChatGPT is not in any way conscious or self-aware in any way, shape or form and interacting with it as if it is is simply misguided, maybe even dangerous.

Chatbots are designed to be agreeable and supportive, which can lead you down completely fabricated, potentially crazy routes with complete confidence. If a user is interacting with something they believe to be trustworthy, especially when under a suggestive, easily influenced state, things could go very wrong. This has led to concerns about the (albeit limited) cases of what is being described as “ChatGPT psychosis”, where the AI actively encourages delusional thinking.