Psychedelics News December 2020

December was no sleepy winter month this year as the psychedelics field keeps pushing forward. We identified seven new significant papers that advanced the field of psychedelics. NGOs kept pushing for access and this year has seen patients in Canada (finally) get access to psilocybin-assisted psychotherapy. MAPS shared that its Phase III study was a success and that a final approval is expected within two years.

First Week of December

Research

A review of psychedelic therapy and nature relatedness argues that both may work in synergy. If you maximizing nature relatedness during psychedelic therapy, it could provide added benefits. The authors from Imperial College London and Synthesis offer a review of what we currently know about both topics together.

NGOs and Advocacy

Numinus and MAPS PBC (the public benefit corporation owned by MAPS) seek to give MDMA-assisted psychotherapy for PTSD in a compassionate use trial. The companies are pursuing this in Canada, where recent regulatory changes give this trial a fighting change of expanding the access to these therapies before the Phase III trials are finished.

Corporate Corner

Silo Pharma announced that it will be working together with Maastricht University (led by Kim Kuypers). Together they will investigate the effect of repeated (low) dosages of LSD and psilocybin on cognitive and emotional dysfunctions in Parkinson’s disease.

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Second Week of December

Research

Usona has published a process for making 5-MeO-DMT at multigram-scale (139g made in the paper). By making this information publicly available, the institute prevents others from trademarking (this way of making) 5-MeO-DMT.

Imperial College London, in cooperation with Small Pharma, has been granted permission to start a trial to examine the combination of DMT and therapy. A first trial (n=32) will be done on healthy volunteers, a second trial (n=36) in patients with clinical depression.

And a recent nature paper by a team at UC Davis describes an analog to ibogaine (tabernanthalog) with similar therapeutic potential that is non-toxic, and non-psychedelic. Although it’s only tested in animal (rodent) models, it shows promise as a safer and effective way of helping people fight addiction and mental health in general.

A day later two viewpoint articles were published that may be of interest in the context of this finding. David Yaden and Roland Griffiths argue that the subjective effects of psychedelics are necessary for their enduring therapeutic effects. Whereas David Olson (co-author on tabernanthalog paper) argues that it may not be so. Matthew Johnson did offer his own perspective on Twitter where he rightly points out that the experience is rooted in biology, there are interactive effects, and that different types of psychedelic (therapies) will be needed and welcome.

NGOs and Advocacy

After much waiting, a few healthcare professionals are now approved to use psilocybin for professional training in Canada. TheraPsil, which earlier this year got approval for use of psilocybin in patients with life-threatening diseases and later also depression, was the leading force behind this approval.

Corporate Corner

Psychedelic stocks experienced a big rise last week, even elevating MindMed to a valuation of $1 billion.

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Third Week of December

Research

This semi-final week of the year is a great moment to review what we know about psychedelics. A review by Antonio Inserra, Danilo De Gregorio & Gabriella Gobbi presents the neurobiological therapeutic mechanisms by which psychedelics work. In the paper they focus on outcomes on 1) neuroplasticity, 2) immune system, and 3) effects on neurotransmitter (-modulator) systems.

A further analysis by Andrea Luppi and colleagues of experiments done in 2016 sheds more light on how LSD alters brain function. The novelty of the paper is that it presents more data on how changes take place over time, and how these map onto subjective experiences (e.g. ego dissolution).

A follow-up study (n=18) to Anderson and colleagues (2020) finds that attachment anxiety, but not attachment avoidance, decreased significantly 3 months after psilocybin-assisted group therapy.

NGOs and Advocacy

MAPS has shared that their (part 1 of 2) Phase III FDA study is a success. This means that there is a significant difference in PTSD measures in the double-blind placebo-controlled 90 person study. The funding they have raised (from PSFC, Tim Ferriss, and many more) will allow them to go through the FDA final studies/approval (expected 2023). MAPS will raise an additional $30 million to also get MDMA-assisted therapy for PTSD approved in the EU (EMA).

Corporate Corner

Beckley Psytech (the spinoff from the Beckley Foundation) raised $18.6 million to continue their work with 5-MeO-DMT. Part of the funding came from the Noetic venture fund. It will be interesting to (in a few years) see how they will develop, especially as Usona last week made the process for making 5-MeO-DMT at scale public.

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Fourth Week of December

Research

Music selection during psychedelic therapy was investigated by Justin C. Strickland, Albert Garcia-Romeu, and Matthew W. Johnson. Their study found no significant effect, though on several outcomes it did trend toward overtone-based music (vs classical music). With only ten participants, the study is quite limited and highlights the need for larger trials to study this part of the therapeutic setting.

A literature review and meta-analysis of MDMA-assisted psychotherapy studies (n=67) found that at two dosages (75 and 125, not 100mg) it significantly improved PTSD scores (CAPS-IV). The number of participants in the analysis was small, and all results trended towards significance. But this study, in comparison to the current narrative around MDMA-assisted psychotherapy for PTSD, is less favorable than we normally read in the papers.

The perception of psychedelic researchers is influenced by their use of psychedelics and association with psychedelic culture in a survey study by Matthias Forstmann and Christina Sagioglou. The former negatively influenced ratings on their integrity, the latter on the quality of their research. The study was limited to hypothetical scenarios and done via an online survey tool, but at the very least shows that negative stereotypes still persist.

NGOs and Advocacy

For those who want to learn more about how to hold psychedelic sessions, Jeffrey Guss and colleagues have recently released the Yale Manual for Psilocybin-Assisted Therapy of Depression. The 79-page manual offers information on methods, structure, and more to consider around psychedelic-assisted therapy.

The battle for legalization and access continues. In the final week of December, Syntac was the second NGO to get approval for psilocybin-assisted therapy in Canada.

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