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Home > Article > Psychedelics

Psychedelics 101: The Emergence, Regulatory Framework, & the Need for Quality Testing

By Martha Hernández

Published: Mar 15, 2022   

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Psychedelics 101: The Emergence, Regulatory Framework, & the Need for Quality Testing

We live in a world plagued by mental health diseases, which only seem to magnify each year. Conditions like addiction, depression, anxiety, and post-traumatic stress disorder affect a large swath of the population – according to a 2017 study, depression alone affects over 4.4 percent of the global population – and current events like Covid-19 don’t tend to help matters. 

Can you imagine a world where anxiety, depression, addiction, and post-traumatic stress disorder are remnants of the past? It’s a tough rationalization, especially considering the aforementioned current events. But what if society could significantly diminish these debilitating mental health conditions with a single use of a substance? It may sound too good to be true, but that’s exactly what’s been said about several psychedelic substances, including magic mushrooms.

Psychedelics like psilocybin and psilocin in magic mushrooms, ketamine, N,N-dimethyltryptamine (DMT), mescaline (peyote), and lysergic acid diethylamide (LSD) have been cast aside by US federal lawmakers. These substances have been categorized as Schedule I drugs in the United States that are claimed to be devoid of medicinal merit and highly addictive. But this is a lie, and modern society is finding its way back to these substances.


Psilocybin/psilocin

Psychedelic substances, in general, have the ability to induce transcending changes in mood, perception, and cognition. Psilocybin, for example, has been labeled as a “breakthrough therapy” by the US Food and Drug Administration (FDA) for addressing treatment-resistant depression – a ruling that came despite the drug's Schedule I stance.

Various places around the US have decriminalized magic mushrooms, such as Denver, Oakland, Santa Cruz, Washington, DC, Seattle, Ann Arbor, and Somerville. In 2020, Oregon boldly legalized psychedelic mushrooms outright for treating mental health conditions. And in Canada, doctors can request access to restricted substances like psilocybin and ecstasy from Health Canada.

Often, the health benefits of a substance that are reported in the scientific literature are gleaned from animal models (pre-clinical) and may not translate to humans. With psilocybin, however, clinical trials (on humans) have demonstrated the power of the substance in treating depression. A recent study of 24 participants produced “large, rapid, and sustained antidepressant effects in patients with major depressive disorder.” While this study had a small sample size, another clinical trial gave one dose of psilocybin to 233 people. Participants provided with the highest dose of psilocybin showed the greatest results. Three months’ later, the antidepressant effects were still present from the single dose.


Ketamine and DMT

Other psychedelics also show promise for treating depression. A single dose of ketamine, for example, was found to have quick and effective antidepressant properties for treating major depressive disorder and bipolar depression. DMT has also demonstrated antidepressant and anxiolytic properties. The swift pace at which these substances spring into action is as startling as it is liberating. Fortunately, the scientific field is validating the decision of awakened places that have chosen to relax prohibitive laws.

Psychedelic Drugs of Interest


Figure 1: A schematic representation of psychedelic drugs of interest (Figure courtesy of
CloudLIMS).

The data is coming, but do you have a LIMS?

This volume of scientific literature is generated by research groups in academia, clinical R&D labs, and companies conducting in-house experimentation around their production. These data may relate to chemical purity, dose response curves, or p-values comparing data sets to determine statistical relevance. No matter what the data means, they should and will help guide future legalization efforts, especially if these psychedelics prove to be as powerful as current literature indicates.

The mountains of data may be daunting, and to make sense of it all, the data will need to be properly managed, processed, and analyzed. As these data will likely drive clinical applications for psychedelic; they’re a treasure that needs to be mined with the utmost diligence and organization, so a good Laboratory Information Management System (LIMS) is essential.

A LIMS can help a lab:

  • Manage testing, calibration, and validation of data.
  • Schedule preventative maintenance of analytical instruments.
  • Manage standard operating procedures and documents.
  • Track data changes, including who made the changes with a date and time stamp.
  • Manage training requirements and certificates of analysis (CoAs).


Laboratory Information Management System (LIMS) for Psychedelic Drugs

Figure 2: A Laboratory Information Management System (LIMS) for managing tests for psychedelic drug (Figure courtesy of CloudLIMS).

Because of the aforementioned Schedule I status of these psychedelics, researchers studying them will need to track the storage and use of the substances, and the subsequent waste streams that are generated. The tracking aspect of the LIMS platform can aid keeping mass balances in check and can point to any anomalies in real-time.


Summary

As we look to quickly evolve and transcend the mental health conditions that afflict our modern world, the therapeutic properties of psychedelics hold substantial promise for chaperoning us to better health and happier existences. Embarking on this decreasingly taboo path will require lots of data to validate the decisions to enable access to substances that were once brushed aside as worthless. A strong LIMS platform can simplify the gathering, processing, analyzing, and storing of that data, such that research efforts can more readily assess the full power of the psychedelics.


Martha Hernández is a scientist at CloudLIMS.com


Martha Hernández

Scientist, CloudLIMS.com

Martha is a chemist with expertise in diverse areas of analytical chemistry. She had worked as an analyst at a licensed 3rd party analytical laboratory where she focused on developing and validating analytical methods for bioequivalence studies. Later, she had served as a quality control expert in the analytical domain and as a monitor in clinical trials. Her interest in the clinical industry led her to be a part of two of the biggest hospitals in Mexico where she gained expertise in hematology, microbiology, and blood banking. Later, she became a member of the team of forensic chemical experts and started working from day one as a specialist in narcotics and drugs. This enabled her to gain rich experience in GC-MS, FTIR, HPLC-MS/MS, ICP-MS, and other analytical techniques for the separation, detection, and quantification of different molecules such as cannabinoids. She had participated in multiple oral trials defending her legal opinions and worked as an expert consultant. She had worked on the synthesis of small molecules for testing them on multi-drug resistant bacteria and mycobacteria, further developing her analytical skills in column chromatography, thin-layer chromatography, microbiology, and compound elucidation by NMR and HRMS. She carried out a research stay at the University of Barcelona with the organic synthesis team. She had also worked on natural products in France and presented her work at conferences in the USA and France. She received awards and accolades for her exceptional work. She has participated in several conferences as a moderator as well. Martha holds a bachelor’s degree in Clinical Chemistry from the Faculty of Medicine UANL and a master’s degree in Pharmacy from the Faculty of Chemical Sciences UANL, Mexico.

 

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