ATAI's Aya Project; Prohibition's Burden; Psychedelics for Pain; Challenge of Mental Illness; and more

Jul 22, 2020

ATAI Enters the DMT Race

I was about to hit send when I got this announcement, here are highlights from the FierceBiotech announcement:

“The company aims to develop new formulations of the brew’s active ingredient, N,N-dimethyltryptamine, or DMT, to use alongside talk therapy to treat “a variety of mental health disorders.”…
ATAI will also pair its DMT products with a digital therapeutic, which can help doctors monitor patients remotely and tailor treatment to each patient…
Isolating DMT could result in a drug that triggers psychedelic experiences that are much shorter than what’s usual with ayahuasca and other substances, such as psilocybin, the active ingredient in magic mushrooms.
A shorter experience could open up psychedelic-assisted treatment to people who can’t or don’t want to undergo a longer psychedelic experience, said ATAI CEO Florian Brand in a statement…
“I think there are methods to consider for alternative routes, such as mucosal administration,” Short said. That could include delivering the drug to mucous membranes in the nose or mouth, but Short declined to discuss specifics. The company aims to start clinical trials in early 2021.”

Preamble: The Bureaucratic Burden of Prohibition

Coming up on Friday's Trip Report Pro dispatch—have I mentioned we have a premium offering which goes out to hundreds of investors, activists, operators, executives intent on understanding the emerging psychedelic space???— we're going to look at the impact of prohibition on scientific progress and the bureaucratic burden on scientists to comply with federal regulations pertaining to research on controlled substances.

Here's a short preamble:

Last week the Medical Psychedelics Working Group got working with a digital launch event, which I regretfully missed. Fortunately, they have made the recording available.

Who?

To recap, Drug Science is a group in the UK founded by David Nutt, psychiatrist, scientist, and advocate sensible drug reform, currently at the Imperial College of London.

Prof. Nutt has long argued for evidence-based drug policy and was infamously ousted for his position from the UK government's Advisory Council on the Misuse of Drugs. Acknowledging that the addiction potential of MDMA was no more than the addiction potential of horseback riding—an allegory meant to reframe the actual qualities of MDMA as compared to the government-sanctioned position, was enough for his departure.

For this, he was sacked, which makes the establishment of the Medical Psychedelics Working Group all the richer since it includes Members of Parliament Crispin Blunt and Jeff Smith and has the stated goal of reforming drug policy in the UK.

While many groups are working towards various goals in the psychedelic landscape, Drug Science is unique because they're made up of a wide swath of stakeholders (scientists, clinicians, policymakers, and industry people) all seeking to the right the wrongs of prohibition as a first step in the integration of psychedelics into conventional medical practice.

“Drug Science believes that the future of psychedelic medicine is extremely promising, and there is potential for widespread application of psychedelic drugs within public health models. The UK is a world leader in the development of clinical psychedelic research, which is now expanding globally.
However, current UK regulations have created serious and considerable barriers to legitimate research associated with Schedule 1 regulations. While current legislation does not preclude scientific research with these drugs, it does make them significantly more difficult, time-consuming and costly to study.”

The burden of Prohibition on Science

I want to better understand the actual implications of prohibition on the scientific progress in psychedelics in both academic and industry settings, and Friday's dispatch will dig into this topic.

Won't you join us?

Trip the Pain Away?

The burden of pain, particularly chronic pain, is an area I've been passionate about for the last few years outside of psychedelics.

A recent article from Drug Topics highlights the growing interest in psychedelic-based pain treatments.

I am bullish on the idea and wrote about psychedelics and pain a few weeks ago in response to research out of UCSD and the role of neuroplastic changes in chronic pain in Psychedelics for Chronic Pain? The Problem and The Unmet Need:

“In painful conditions that extend beyond the normal healing time, the nervous system develops a heightened capacity to produce pain in a process called Central Sensitization.
So even though the pain is experienced at a certain part of the body, perhaps with certain movements (which reinforces the idea that the pain is the result of local tissue damage) the culprit is, in fact, the result of neuroplastic changes in the brain and spinal cord…
Without getting overzealous about the potential for psychedelics to change the world and treat every ailment, I think that serious exploration into Psychedelic Assisted Therapy directed at Chronic pain in conjunction with physical therapy and pain education deserves a close look. With the understanding that Chronic Pain is both a neurological and a conceptual/cognitive condition research into psychedelics for pain should consider following in the footsteps of MDMA and Psilocybin assisted therapies and when it comes time for clinical research including Therapeutic Pain Science Education in conjunction with preparation and integration sessions I am convinced will yield results for chronic pain.”

I am less confident about the idea of psilocybin as next-generation anti-inflammatories or pain killers.

I think the utility is in reshaping neural pathways that contribute to persistent pain in conjunction with Physical Therapy, exercise, acupuncture, education, etc.

The trouble with medicating chronic pain is similar to The Trouble Medicating Mental Illness….

The Trouble Medicating Mental Illness

An article highlighting the work of psychiatrist/historian Joel Braslow came across my desk in which he laments the decades-long shift in psychiatry:

“..there’s our shrinking vision of what causes psychiatric disease and what we can do clinically for those who suffer from it. Prior to the late 1960s and 1970s, American psychiatrists tended to take a more expansive view. Today’s greater focus on the individual and a simple model of disease has helped justify the belief that drugs or psychotherapies hold the key to alleviating psychiatric disease. However, this view ignores the fundamental nature of psychiatric disease as simultaneously biological, psychological and social.

Back in December, we covered the Biopsychosocial Model in Psychedelics and the Resilient Phenotype:

“Psychedelic stakeholders especially would do well to familiarize themselves with the Biopsychosocial Model.
“The biopsychosocial model reflects the development of illness through the complex interaction of biological factors (genetic, biochemical, etc.), psychological factors (mood, personality, behavior, etc.) and social factors (cultural, familial, socioeconomic, medical, etc.)”
Like psychedelics, the biopsychosocial model is not new, but it has struggled and operated under stigma, condescension, and misunderstanding in medical circles since its inception.
And it’s not just intended to model psychological conditions. No pathology is free from the influence of the mind and society.”

This transition that Braslow and the above article highlights is a manifestation of the reductive quality of pharmaceutical science of the time.

Hopefully, the advent of psychedelic science offers additional insight into managing complexity in clinical science. The model of psychedelic-assisted therapy provides a way forward for a new model of combining a therapeutic relationship with psychopharmacology.

The article finishes with:

“Once we acknowledge the reality of mental illness as a disease that robs its victims of meaning, social connections and the ability to function in contemporary society, we can start designing interventions that address this reality. We cannot simply wish away the complexity of psychiatric disease and the kinds of interventions that are necessary for humane, scientifically based care.”

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