Discover more from The Trip Report by Beckley Waves
How to Start a Psyhcedelic Clinic: Part 2
The First Opportunity in the Nascent Field
In part 1 we covered pertinent information about required training, clinical research the unique designation of Breakthrough Therapy and Expanded Access which will allow for the first non-study patients.
In Part 2 we'll explore why Psychedelic Medicine is unique to other forms of treatment and why the psychedelic entrepreneur must consider the history, role of the guide or therapist and of course the Clinical Setting.
Part 2A: Because of its role as an adjunctive treatment to Psychotherapy as in the current trials, or perhaps group therapy as has been practiced in retreat settings, Psychedelic Medicine demands a new approach to the clinics and outpatient settings that doctors, patients, and payers (insurance, medicare, etc.) are used to. I am not sure how much thought goes into the doctor-patient relationship when developing and marketing conventional psychiatric drugs but Psychedelic Medicine demands it.
Part2B: Because of its history as an illicit drug, enthusiasts, advocates, proponents and especially entrepreneurs must be clear about the data and what interpretations and claims can and cannot be made based on the research to date. Secondly, Because there is a strong and enthusiastic Psychedelic Community there are going to be varied opinions on the roll-out of psychedelics from illegal to legal, sacred to profane, and indigenous to modern. Entrepreneurs must have a sense of history about the cultures that have made use of these tools in the past.
2A: Set and Setting
Most pharmaceutical drugs are developed and dosed to maintain adequate blood levels so that the drug works continuously. Conventional pharmacology, and psychopharmacology, in particular, are based on developing compounds with specific affinity to cellular receptors in order to upregulate or downregulate the mechanisms or pathways that the receptors act on.
Commonly people take a pill based on the 24-hour diurnal cycle in order to maintain this blood level. Pills that you need to take once a day are preferable to pills that you need to take twice a day, which are preferable to pills you must take 3 times a day.
However, most scientists and clinicians seem to agree that the benefits that are seen from psychedelic therapy are not based on maintaining a constant supply of MDMA, or psilocybin or Ayuhasca in the bloodstream or at receptor sites.
Rather, the psychedelic experience and subsequent integration seem to rewire, reprogram parts of the nervous system associated with attention, memory, fear, the sense of self and perhaps others.
This a fundamentally different paradigm for scientists attempting to discover or create new drugs.
Time spent with the clinician is likely never in the mind of chemists concerned with intake, affinity, and pharmacokinetics.
However, for the Psychedelic Entrepreneur seeking to build this industry, she must start with the doctor-patient relationship and clinical setting.
Set and Setting
There is a phrase invoked whenever members of the psychedelic community are asked about bad trips or those who injure themselves or others while tripping; “Set and Setting”.
The belief is that under the appropriate guidance, conditions, in the right environment, for the right reasons these compounds are therapeutic agents or spiritual tools. They are applicable to releasing one from the bondage of past trauma or to exploring one’s consciousness.
By Contrast, the psychopharmacological industry is, for the most part, a system in which patients are given a supply to take on their own and they are responsible for maintaining the regimen. (Yes, there are infusions and other modes of therapy that are administered in hospital or outpatient clinic.)
For this reason, Psychedelic Medicine will not be a runaway success like the current line up psych meds lie Xanax, Zoloft or Prozac.
Clinicians and entrepreneurs that will be building psychedelic medicine will, therefore, need to focus on finding (and possibly training) quality therapists and creating an environment that fosters the type of emotional work that Psychedelic Medicine aims to catalyze.
2B: Out of the Shadows
The most apt comparison when discussing Psychedelic Medicine is cannabis, which has similarities as an underground drug coming into the light of the legal market.
Inevitably the emergence of Psychedelic Medicine and a psychedelic industry is going to be compared to the recent cannabis movement. Both share a trajectory from underground and illegal, both are touted as alleviating significant medical conditions, both have activists advocating for decriminalization, legalization, and medicalization.
The principal components of cannabis, THC, and CBD can be bought as a whole plant, tincture, gummy, brownie, coated almonds, balm, vape pens, and others, many others.
It must be purchased at sanctioned facilities.
But Cannabis is marketed and sold as both recreational products (like alcohol) as well as medicinal products (like pharmaceuticals).
It is a weird space, with different players, many objectives and competing incentives that have created tension for the legitimacy of Cannabis as medicine (along with the inability to conduct high-quality research due to prohibition).
Initial medicalization efforts were directed at alleviating the suffering of people with HIV and AIDS and California was the first state to sanction Medical use in 1996 through Prop 215. A noble and worthwhile effort.
By comparison, the first wave of psychedelic medicine stands on the shoulders of the scientific process rather than political activism.
There will be MDMA from MAPS and Psilocybin from Usona and Compass and these will never reach your home, you won't pick them up with your other meds at Walgreens.
Unlike Cannabis evangelists who are often overzealous about the legitimacy of the medicinal claims. The conditions MDMA and Psilocybin are intended to treat are defined and their efficacy is being rigorously tested.
They will be administered in a clinic under the responsibility of trained therapists and clinicians and except with the consumption you will never handle them.
The medicinal case for marijuana is a house of cards in my opinion and medicalization, while it started with a legit case, to alleviate the suffering of the dying, the movement has jumped the shark and only time will tell what unintended consequences we might see. The “Vaping is Safer” argument is case in point.
Psychedelic Medicine, with it’s careful plodding and scrutiny through research and high-quality clinical trials have at least two conditions that clinicians and entrepreneurs can confidently market to and robust scientific literature to back it up and it would be prudent to focus on these conditions rather than touting Psychedelic Medicine as a panacea.
The Psychedelic Clinic
A major difference, from an investment perspective, between both Cannabis and conventional pharmaceutical is that Psychedelic Medicine will require clinical infrastructure unlike either.
The first wave of psychedelic medicine will be delivered in specialized clinics, with specially trained therapists and clinicians as part of a protocol that requires more of the clinician's time than conventional psychotherapy, much more, along with more space and resources.
The first opportunity and the first challenge will be the creation of clinics that satisfy the criteria set forth by the FDA.
Presumably, MDMA will be the first compound that reaches Expanded Access and MAPS has set forth the basic criteria for interested clinics. From the MAPS website:
Sites may apply with MAPS PBC to assess eligibility and obtain the required training to administer MDMA-assisted psychotherapy for PTSD under an approved protocol.
Applicants are required to have:
Treatment Facility conducive to MDMA-assisted psychotherapy
Therapy Team, qualified and able to complete MDMA Therapy Training Program
Prescribing Physician who can obtain a DEA Schedule I license for MDMA
From my research, I can identify three categories of the first wave of psychedelic clinic:
2. Venture/startups like Field Trip Ventures who plan to create and manage multiple locations
3. Smaller individuals and groups who are not part of the ongoing research but plan to satisfy the requirements of the Expanded Access Program, such as The Landing in Philadelphia.
People involved in the first category will be familiar with the clinical and organizational requirements since they are modeled off of the participating study sites. Larger operations, such as the second category will have done the research, hired the appropriate people, presumably from current study sites.
Presumably, those involved in creating single clinics will have gone through MAPS training along with a network of colleagues and already established psychotherapy practices that they will transition into Psychedelic Clinics.
In Part 3 we’ll explore the question who is going to pay for it?