Filament Health is the leading supplier of psilocybin for academic research. We currently supply our botanical psilocybin drug candidate, PEX010, on a low cost basis to over 30 institutions globally, including Johns Hopkins, UPenn, and University College London. This philanthropic program facilitates much-needed research into a range of mental health indications.
Among the most prevalent of these indications is alcohol use disorder (AUD), which affects an estimated 400 million people worldwide. We spoke to Dr. Leah Mayo and Dr. Mathias Ebbesen Jensen, researchers who are leading clinical trials which examine psilocybin's potential for treating AUD at the University of Calgary and Psychiatric Centre Copenhagen respectively. Dr. Mayo and Dr. Ebbesen Jensen shared insight into their research:
1. What makes psilocybin a compelling candidate for treating alcohol use disorder compared to existing treatments?
Dr. Mayo: Psilocybin-assisted psychotherapy is a promising candidate for many disorders, including AUD, because it may have the potential to help shift maladaptive thought and behavioral patterns, including those that can drive continued alcohol use when individuals are trying to cut back or abstain. Psilocybin, when combined with an appropriate therapeutic intervention, can create a situation where the brain is more ready to engage in ‘new’ learning, harnessing the neuroplasticity induced by psilocybin together with the motivation to reduce alcohol use to shift existing brain circuits that would ordinarily promote continued alcohol use.
Dr. Ebbesen Jensen: Current evidence suggests that one or very few administrations of psilocybin, when combined with appropriate care and support, can produce robust and lasting reductions in alcohol craving and consumption—far exceeding the drug’s acute effects and presence in the body. The precise mechanisms underlying psilocybin therapy remain to be fully understood, but it appears to both catalyze meaningful psychological processes and enhance cortical neuroplasticity in brain regions critical for addiction. Moreover, although psilocybin administration requires substantial resources, it may be preferred by many patients and could prove more cost-efficient than current treatments that require daily or near-daily administration
2. Was botanical psilocybin of particular interest to you? If so, why?
Dr. Mayo: The idea of botanical psilocybin is interesting. We’ve worked a lot in the cannabis space, where we know the primary psychoactive component of cannabis is THC and a lot of the research focus has historically been on the effects of THC itself. However, many people are now interested in the potential ‘entourage effect’, or the impact of other non-THC cannabis components. Whether or not there will be a similar movement with psilocybin remains to be seen, but is definitely interesting!
Dr. Ebbesen Jensen: Botanical psilocybin was not a particular focus for us. However, Filament proved to be a highly efficient and reliable provider, which was invaluable when we were struggling to get the project off the ground. That said, botanical psilocybin may have certain advantages that have yet to be thoroughly investigated. To my knowledge, preliminary animal studies suggest that natural psilocybin may exhibit greater neuroplastic effects compared to its synthetic counterpart. It will be interesting to explore these differences in humans in the future.
3. What challenges have you faced in recruiting participants and how do individual differences impact outcomes?
Dr. Mayo: Our biggest challenge in recruitment so far has been how many people are interested in psilocybin; we’ve had people sign up for the study who don’t even have an alcohol use disorder. I think this speaks to how favourable psychedelic-based interventions are portrayed in the media right now. However, it can cause issues with participants expecting that this is a cure-all, when, like all interventions, it won’t work for everyone. As a result, mitigating expectancies is a big issue for us, and other researchers in this space.
Dr. Ebbesen Jensen: Recruiting participants for clinical trials is always challenging. In our case, the stigma surrounding AUD and the illegal status of psilocybin may have made it even more difficult. Another challenge is ensuring a representative sample of AUD patients—many who express interest in participating are already pro-psychedelics and have prior experience with these substances. AUD is a highly heterogeneous condition, and future research should focus on analyzing subgroups to better understand variations in treatment outcomes. For instance, studies suggest that personality traits can influence the effects of psilocybin, which may be an important factor to consider in future trials.
4. Can you explain what the process of administering psilocybin in a clinical setting looks like? Any best practices?
Dr. Mayo: There is a lot of preparation and support that goes into each psilocybin administration session. Our participants have to complete a thorough screening process to determine if they are eligible for the study. Those who are eligible will then have a dedicated therapist assigned to them, who they will meet with before dosing, up to 8hrs over a couple of weeks. During the dosing session, they are provided eyeshades, choose one of our preselected music playlists to listen to, and get to lay back and relax. We have the therapist and a co-monitor with the participant through the dosing session (up to 8hrs), though they are there more for support than for providing therapy during the session. Afterwards, the participant comes back the next day for an integration session, and then will come in weekly for the next month for additional therapy. Our therapists adhere to a standardized therapeutic protocol based off an existing psychotherapy used in AUD treatment (Motivational Enhancement Therapy), ensuring that all patients will receive evidence-based care, in addition to psilocybin.
Dr. Ebbesen Jensen: There are yet to be established formal guidelines and best practices. However, most studies adhere to some overall practices including some form of pre-drug preparation meetings, monitored drug sessions accompanied by music listening and in a calm and comfortable facility, and some form of post-drug debriefing or integration sessions. These are safeguards to ensure the safety of the drug administration which induces a psychologically vulnerable state for some hours. It remains to be formally investigated whether these safeguards are also enhancing the therapeutic efficacy.
5. If the results from your trials are positive, what hurdles could stand in the way of psilocybin becoming an approved treatment for AUD?
Dr. Mayo: Right now, the biggest hurdle is how this sort of intervention would be administered within existing healthcare infrastructure. It is fairly resource-intensive to have 1-2 therapists present throughout the 8hr dosing session, as well as the preparation (pre-posing) and integration (post-dosing sessions). We also lack any standardization or regulatory oversight in training of therapists and practitioners, so it is unclear what would make someone ‘qualified’ to be a psychedelic-assisted therapist. We are able to handle these challenges on a small scale, such as in our clinical trials, but it isn’t clear how this would work when things would become more widely accessible and we would need to dramatically scale up these efforts.
Dr. Ebbesen Jensen: This was also the first study to characterize the pharmacokinetics and pharmacodynamics of psilocybin in AUD patients. Our results are promising but should be interpreted with caution, as the sample size was small (n = 10) and there was no control group. That being said, we observed robust reductions in alcohol consumption and craving, which were sustained for at least 12 weeks. We are currently evaluating this single-dose therapy approach in a phase 2 trial. Ultimately, large phase 3 trials will be needed to firmly establish safety and efficacy before regulatory approval. Even if psilocybin is approved, additional work will be required for implementation, including the development of therapist training programs.
