Expanded Access; Microdosing & Meditation Study
Today we’re focusing on two developments at the intersection of access and research:
First up, Sunstone Therapies, a clinic and research center focused on psychedelics and cancer care, announced its participation in the MAPS’ Expanded Access Program
First, a word from our friends at the Open Foundation:
The Interdisciplinary Conference on Psychedelic Research is returning for its fifth edition on September 22nd-24th, 2022, in Amsterdam, the Netherlands.
Confirmed speakers include Paul Stamets, Katrin Preller, Michael Bogenschutz, David Nutt, Amanda Feilding, Roland Griffiths, Kim Kuypers, Rick Doblin, Janis Phelps, David Nichols, Monnica Williams, Bill Richards, Friederike Holze, Peter Gasser, Erika Dyck, Mendel Kaelen, Matthias Liechti, and Bernardo Kastrup.
OPEN has given us a special €30 discount code for our community! Use the code ttrlive30 when checking out your live stream tickets before Sep 20th here: https://icpr-conference.com/tickets
Update on MAPS’ Expanded Access Program
Expanded Access (EA) is an FDA-sanctioned program that allows patients that have exhausted all other treatment options access to investigational products not yet approved by the FDA.
These programs are set up as open-label research protocols that collect data but are separate and not included in New Drug Applications for FDA approval.
From the FDA:
“Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.”
Interestingly, the first compassionate use program in the US was established in 1978 to allow access to medical marijuana. Then in 1987, the FDA formally established EA in response to dying HIV/AIDS patients requesting access to drugs in development.
In January 2020, the FDA agreed to allow an EA of MAPS’ MDMA-Assisted Therapy for 50 patients.
Since then, four clinics in the US have been approved to participate in the program (I could not determine how many patients have been enrolled in the EA to date).
From the press release:
“Sunstone Therapies, a company dedicated to treating the psychological effects of cancer, announces today the launch of a new clinical trial to test the safety and tolerability of MDMA-assisted therapy for patients living with treatment-resistant post-traumatic stress disorder (PTSD). The trial is sponsored by the Multidisciplinary Association for Psychedelics Studies (MAPS), a non-profit research organization that develops psychedelic medicine. MAPS has received Food and Drug Administration authorization to establish an expanded access program for a limited group of patients who meet the study's eligibility criteria…
1 in 5 people living with cancer will experience PTSD at least six months after their initial diagnosis. Of individuals diagnosed with PTSD, more than 30% do not respond to FDA-approved treatments, such as antidepressants and selective serotonin reuptake inhibitors.”
Why EA is Interesting
Expanded Access Programs are interesting because they are a transition between the super rigorous and exclusive clinical trials and eventual real-world practice.
But more importantly, in the context of psychedelic-assisted therapies, EA and such programs have been put forward as the administrative infrastructure layer in several state-level policy initiatives.
I have dubbed this the “East Coast” model of state-level policy as it has gained traction in Eastern states as a way to expedite and scale ‘research-based treatment’ programs before and immediately after FDA approval.
“…the seemingly more reserved East Coast approaches seek to work within the previously established frameworks erected by the federal institutions, such as investigator-initiated clinical trials, Expanded Access Programs, and possibly the Right to Try Act.
East Coast models are structured to use state funds to develop research programs and subsidize access to what we might call ‘research-based-treatment’ for groups with high rates of mental illness, such as veterans and frontline healthcare workers.”
To be clear, MAPS has received authorization for only 50 patients to enroll in its EA program, but as this cohort completes enrollment and, hopefully, the data looks good, the FDA is expected to increase this number.
Meditation and Microdosing Study
“We still know very little about the relationship between meditation practice and psychedelic use.”—Marco Schlosser
A Beckley Foundation-sponsored study of the effect of microdosing on meditation training has opened for enrollment on the smartphone-based platform, Quantified Citizen.
In the below video, collaborator Marco Schlosser from University College London gives a brief overview of the study.
This study combines several features worth exploring.
First, the trial design leverages the smartphone-based platform Quantified Citizen. As was a central theme of this newsletter for some time, the role of technology in the psychedelic renaissance is noteworthy. For one, it allows for research at a distance.
Until recently, clinical trials relied on local populations, and the advent of remote patient monitoring and patient-reported outcome measures via smartphone allows anyone in the world to participate in this trial.
Second, despite a large amount of anecdotal support and popularity, the practice of microdosing has yet to garner scientific support. To date, trials have been unable to distinguish the effect of microdosing from placebo controls in several areas, such as mood, creativity, and well-being. This is one of the more polarizing areas of the psychedelic field and will likely only continue to be the case as more and more people give microdosing a whirl despite the evidence for benefit.
Finally, the cultural and historical intersection between psychedelics and meditation is significant, but the scientific literature is sparse.
Notably, in a previous trial run on the Quantified Citizen platform, the Microdose.me trial, the most common reason for subjects’ participation was related to meditation:
“‘Enhancing Mindfulness’ was reported as the most widely endorsed motivation for microdosing in the largest microdosing study to date, which was conducted by our collaborators at Quantified Citizens between 2019 and 2020, and comprised over 10,000 participants.
Harris Bricken’s Vince Sliwoski has provided excellent coverage of the proposed rules for the Oregon Psilocybin Services program. The details of this program, as it is the first of its kind, will be under intense scrutiny as seemingly small nuances could significantly impact the cost and accessibility of psilocybin services. Vince has done an incredible service by keeping us up to date on the nitty-gritty details.
“Remarkably, we have discovered that psychedelics are also potent anti-inflammatories and immunomodulators in peripheral tissues. In this review, the discovery of this phenomenon and the development of psychedelics as potential therapeutics for human inflammatory disease is presented. We believe that certain psychedelics represent a new class of small molecule, highly bioavailable, anti-inflammatory that is steroid sparing and efficacious at sub-behavioral levels that can be used to treat and prevent a variety of inflammatory-related diseases and conditions”
“Molecule has a growing list of partnerships, such as PsyDAO, which aims at using Molcecule’s model to create community-owned psychedelic IP-NFT in an attempt to move away from monopolies on research. Core developer Matt de Caussin explains:
“We see PsyDAO’s core mission as developing an IP asset class that can eventually support novel psychedelic research in perpetuity. We see all profits flowing back to the community to decide on what to fund. PsyDAO aims to harness the best aspects of for-profit and public benefit through the architecture of the DAO and its governance.””
That’s it for this week. Thanks for reading!