The article F.I.V.E. Clinical: Developing Standards of Care for 5-MeO-DMT was originally published on Microdose.
“5-MeO DMT is the strongest psychedelic on the planet and has the very real potential to eclipse other psychedelics — but, if it’s not handled by people who know what they’re doing, it can also further destabilize and even harm participants. This is a different beast than psilocybin or ketamine.”
A quote from F.I.V.E. co-founder Joel Brierre, and a motivating factor behind the development of F.I.V.E. and its educational and clinical protocols.
“With psychedelic medicine still largely in its infancy, psychotherapeutic approaches with these drugs — and their quality — can widely vary across practitioners and centers. This is of particular concern with 5-MeO-DMT – a highly potent, rapid-acting and short-duration psychedelic that has significant potential to be transformative, but also destabilizing without proper care. Thoughtfully crafted clinical protocols are essential for the safety and efficacy of this powerful medicine” — Manesh Girn, Neuroscience Ph.D. and F.I.V.E. advisor
There’s been a big move towards short-acting psychedelics like DMT and 5-MEO-DMT, but are the current standards of practice ready to match the coming demand?
5-MeO-DMT: “The God Molecule”
A lofty nickname, earned from its powerful, otherworldly experiences. 5-MeO-DMT is a tryptamine-based psychedelic found in both animal and plant species, and can also be synthesized in the lab. Most famously, 5-MEO is found in the parotoid glands of the Sonoran Desert toad, known as Incilius Alvarius or Bufo Alvarius toad.
5-MeO-DMT is related to DMT (dimethyltryptamine) found in ayahuasca brews — yet they are two substantially different compounds. By adding the methoxy group in the R5-MeO position, 5-MeO-DMT is considerably more potent and produces a distinctly different experience to DMT (information paraphrased from the FIVE website, check it out for more on 5-MEO).
While some larger companies are beginning to study 5-MEO and bring it to mainstream research audiences (see GH Research and its Phase 2 clinical trial and Beckley Psytech’s Phase 2b trial of synthetic 5-MEO), the compound is still under-investigated compared to other psychedelics like psilocybin (see FIVE’s research page for more resources).
In summary, 5-MEO-DMT is a very powerful compound with tremendous healing potential. Anecdotally and experientially, people’s perceptual systems can be disrupted, and within seconds users can enter into states of non-duality, where the sense of self can be lost and deep inner exploration and discovery can be achieved. On the more scientific end, reports and clinical data show that a single inhalation of 5-MeO-DMT can induce intense mystical and spiritual experiences, which translate to results like increased life satisfaction and mindfulness, decreased anxiety, stress, and depression.
Powerful, full of potential, and requiring experienced quality of care
So we have a fast-acting, short-duration drug with the potential to heal many different conditions — what’s not to love? With high costs and scalability being a primary concern for companies looking to develop psychedelics for mainstream markets, many organizations are moving toward compounds like 5-MEO.
But these are serious medicines that require a commensurate amount of reverence, education, and preparation. Unfortunately, commercial incentives don’t always create conditions for such thoughtful and thorough development.
This is where F.I.V.E. hopes to help.
“We know that 5-MeO-DMT has the potential to eclipse other psychedelics in terms of efficacy, but we also know that it has the highest potential to harm someone if not held in a safe and well-informed container. We aim to lead by example and set a high standard of facilitation for this molecule by bringing together some of the top minds in the space to create protocols that promote real and lasting change,” said Joel Brierre, discussing the need for experienced practitioners to help guide this stage of 5-MeO development.
As we move into expanded clinical trials — and eventually legal commercial use — the need for experienced facilitators who understand the unique characteristics of the substance will be paramount. Proper facilitation is critical to ensure patient safety and well-being. Unfortunately, some training and protocol providers in the 5-MEO space are not always experienced with the compound. Something that can dramatically affect quality of care.
So F.I.V.E. brought in the expertise of nearly 40 contributors to develop its platform, from former MAPS trainers and clinical researchers to veteran facilitators who operated underground before the psychedelic renaissance. The company also draws data from its brother company Tandava Retreats, the world’s first center devoted to the safe and effective use of 5-MeO-DMT.
“From years of first-hand experience, we know 5-MeO-DMT has the potential to greatly evolve our understanding of mental health. While this molecule can be much more effective than other medicines, that efficacy comes with nuanced considerations for successful administration. We’re really proud of FIVE Clinical, it is our solution to an evolving research space by sharing protocol best practices, and specified education and training. Our mission is to mitigate financial risk for both researchers and psychological risk trial participants.” — Francesca Baci, Director of Business Development for F.I.V.E.
Bringing this into the growing field of clinical development, F.I.V.E. has developed F.I.V.E. Clinical, a program of clinical and training protocols aimed at helping biotech and drug development companies navigate 5-MeO with the highest standards possible. F.I.V.E. protocols are designed to care for every part of the participant’s experience, ensuring safety and best practices on all levels of clinical work.
“With the recent and rapid influx of corporate interest in short acting psychedelics, the most valuable neglected asset in the field is the art of administration, which is a chief strong suit of this team.” — Dr. Joseph Barsuglia PHD (F.I.V.E. advisor)
F.I.V.E. has successfully created protocols for conditions such as Treatment Resistant Depression, anxiety, and other mental disorders.
“The comprehensive program we’ve created is a unique collaborative effort bringing together educators with decades of collective experience,” said Dr. Ben Malcolm, a F.I.V.E advisor.
And this kind of experienced clinical container can have positive effects all the way down the chain. From patient safety and improved outcomes, to optimized results for companies as they go through the long and costly clinical trial process. Utilizing informed protocols can help companies avoid disappointing trial results — an especially important consideration in this time of volatile markets and when working with a uniquely potent medicine like 5-MeO.
We’re still in the early days of this psychedelic renaissance, and as companies and practitioners continue to enter the space, the risks of corner-cutting and shortcuts increase — something that’s potentially harmful to patients, companies, and the industry as a whole.
Expertise and quality of care will help ensure we do things the right way, for everyone involved.
Click here for more information on F.I.V.E. and its services, and here for more on F.I.V.E. Clinical