Psychedelic Revolution Comes Full Circle: 3 Once-Stigmatized Substances Return to Lead A New Era of Mental Health Treatment

Integrating Medical, Scientific, and Subjective Knowledge: The New Psychedelic Research Rush

The value of an integral approach to mental health treatment has become increasingly evident, especially as the field of psychedelic drug research expands.

By combining medical, scientific, and subjective knowledge, experienced practitioners are now able to harness the powerful effects of substances such as psilocybin mushrooms, LSD, and N,N-Dimethyltryptamine (DMT).

This resurgence of interest, fueled by both scientific curiosity and a growing awareness of the limitations of traditional antidepressants, has led to a reevaluation of these natural substances, which have coexisted with humans for millions of years.

As research on the therapeutic potential of psychedelics continues to grow, Google Scholar citations for topics like “psychedelic therapy” and “microdosing” have increased dramatically, reflecting the shift in public and academic interest.

But even most academics will acknowledge their experience with psychedelics is extremely limited. That’s not the case for a generation of psychedelic pioneers, who studied what was available and then took research — and their own healing — into their own hands. Healers, the curious, and those for whom contemporary institutions have failed can all benefit from the invested and cultivated knowledge of decades of entheogenic practice and reverent, diligent study.

Psychedelics vs. Traditional Pharmaceuticals: A Comparative Look at Effectiveness for Major Depressive Disorder and Anxiety

The role of psychedelic drugs in treating major depressive disorder, anxiety, and other mental health conditions has gained significant attention in recent years. This was fueled in no small part to the rave scene of the 90s and the proliferation of psychedelic substances in the underground, including high-quality MDMA, LSD, psilocybin, mescaline, and ketamine, to name the most common but not the only substances available to anyone with some patients during the heyday of the late-90s rave scene in most major cities around the world.

In contrast to the fear-mongering today, very few reports of complications with these substances on their own were reported over many years. And Western medicine hadn’t even considered the effects and situation of using multiple drugs, so didn’t even understand the potential at the time for the value of multi-drug therapeutics in psychopharmacology.

Studies have demonstrated the potential of substances like psilocybin mushrooms, LSD, and DMT to alleviate symptoms and provide lasting relief for patients who have not responded well to conventional treatments such as antidepressants and benzodiazepines.

Unlike traditional pharmaceuticals, which often require ongoing use and may cause undesirable side effects, psychedelic therapies often involve only a few guided sessions, resulting in profound, lasting improvements in mental well-being. This paradigm shift in mental health treatment has the potential to revolutionize the way we approach and manage these complex conditions, offering hope to millions of individuals suffering from previously untreatable disorders.

But the rapid rise in interest in psychedelics as speculative investments has flooded a space that was once the domain of passionate weirdos that often tangled with law enforcement in their quests to provide for their friends and their own needs, bordering on or representing what others call addiction, it cannot be denied.

The Cultural and Historical Significance of Psychedelics: From Indigenous Practices to “Tune in, Turn on, and Drop out”

The cultural and historical significance of psychedelics cannot be understated, as they have played a vital role in the healing practices of indigenous communities for centuries. Native Americans, for instance, have long recognized the therapeutic potential of these substances and utilized them in sacred ceremonies to promote spiritual growth, emotional healing, and social cohesion.

In the 20th century, figures brought psychedelics into the mainstream, challenging societal norms and sparking a cultural revolution that questioned conventional approaches to mental health and personal growth.

Today, we are witnessing a resurgence of interest in a return of these practices, as the scientific community and general public alike acknowledge the potential value of psychedelics in promoting psychological well-being.

Navigating Legalization and Decriminalization: The Future of Psychedelic Substance Use in Society

The current state of legalization and decriminalization of psychedelic substances is a critical aspect of the ongoing conversation surrounding their therapeutic potential.

As the debate over psychedelic legalization and decriminalization intensifies, clear divisions are emerging.

• On one side, some individuals remain staunchly opposed to any changes in the legal status of these substances.
• On the other hand, proponents of reform highlight the apparent contradictions between the growing psychedelic industry’s mission to alleviate suffering and the ongoing persecution of those who practice traditional folk medicine or maintain contemporary sacred rituals involving psychedelics. These individuals have often face imprisonment, stigmatization, and social marginalization due to felony charges, frequently at the federal level, led by agencies such as the DEA.

This complex situation calls for a nuanced approach to ensure that the potential benefits of psychedelic therapies are not overshadowed by outdated policies and lingering misconceptions.

One thing is for certain: organizations like Multidisciplinary Association of Psychedelic Studies has already shown that the regulatory pathway is faster than expecting Congress to change any drug laws, any time soon. MAPS, as the organization is widely known among its fanatically-devoted fandom, has guided MDMA, a schedule I substance, first to be designated by the FDA as a “Breakthrough Therapy,” and now it has announced it will file its submission of MDMA for what’s called marketing approval by FDA in October 2023.

This brings us to the question, What is marketing approval by the FDA?

FDA Marketing Approval

FDA marketing approval refers to the authorization granted by the United States Food and Drug Administration (FDA) for a company to market and sell a specific drug, medical device, or biological product. Before a product can be legally sold in the U.S., it must undergo a rigorous review and evaluation process to ensure its safety, efficacy, and quality.

The FDA marketing approval process typically involves several stages, including:

1. Preclinical testing
   • Before testing a new drug in humans, the manufacturer conducts laboratory and animal studies to evaluate its safety and efficacy. If the results are promising, the manufacturer can proceed to submit an Investigational New Drug (IND) application to the FDA.
2. Clinical trials
   • If the IND is approved, the manufacturer can begin conducting clinical trials in human subjects, typically in three phases:
     • Phase 1: A small group of healthy volunteers is tested to evaluate the drug’s safety, dosage, and potential side effects.
     • Phase 2: The drug is tested on a larger group of participants with the targeted condition to further evaluate its safety and efficacy.
     • Phase 3: The drug is tested on an even larger group of participants to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments.
3. New Drug Application (NDA) or Biologics License Application (BLA)
   • If the clinical trials yield positive results, the manufacturer submits an NDA or BLA to the FDA, providing detailed information on the drug’s safety, efficacy, manufacturing processes, labeling, and proposed use.
4. FDA review
   • The FDA reviews the submitted data, inspects the manufacturing facilities, and evaluates the drug’s safety and efficacy. If the FDA determines that the drug’s benefits outweigh its risks, the agency will grant marketing approval, allowing the product to be legally sold and prescribed in the U.S.

Once a drug has received FDA marketing approval, it remains subject to ongoing monitoring, and the manufacturer must continue to report any adverse events or new information related to the drug’s safety and effectiveness. This process helps ensure that the approved drugs continue to meet the highest standards of safety and efficacy for patients.

As evidence mounts in support of the benefits of psychedelics for a variety of mental health disorders, even career law enforcement argue that it is time to reconsider their legal status for possession and use

As evidence mounts in support of the benefits of psychedelics for a variety of mental health disorders, even many thought leaders with law enforcement backgrounds argue that it is time to reconsider their legal status.

• The harm of these substances is negligible with virtually no physical addiction potential, particularly ones with identical examples found in nature like cannabis and psilocybin, and mescaline, are among the safest of known pharmacological substances
  • That’s to say that the harm of drugs like psilocybin, cannabis, and even LSD and MDMA have been greatly exaggerated, though their potential is profoundly powerful and nothing to be completely cavalier about, either
• The harm associated with these compounds largely stems from the law enforcement implications of these substances
• The data show that over many decades, very few deaths and complications have been recorded, though they are not to be ignored, if we are to keep the numbers of deaths and additional complications due to use of these substances to a minimum, with adequate public health and personal pharmacology education widespread
• These substances seem to uniquely work with many people’s physiology to produce anti-depressant and otherwise emotional adaptation effects with sense of ease of processing information and implications for one’s life.

This shift toward decriminalization is fueled by a growing understanding of the limitations of traditional pharmaceutical treatments and the need for innovative, evidence-based solutions. If successful, these efforts could pave the way for more accessible and effective mental health care, transforming the lives of countless individuals and challenging long-held beliefs about the role of psychedelics in society.

But without concurrent efforts to appropriate modify the regulatory structure for legalization by perhaps even harsher penalties for organized crime, and decriminalization of certain substances likely to be difficult to regulate personal cultivation, anyways — the same harms continue to accumulate and be perpetuated.

Certainly, evidence is lacking of intrinsic harmfulness compared to other substances

Undoubtedly, when comparing the intrinsic harmfulness of various substances, there is a lack of evidence to suggest that psychedelics are inherently more dangerous than other commonly used drugs.

In fact, research has shown that psychedelics, such as psilocybin and LSD, generally possess a low potential for addiction and abuse, and their physiological toxicity is relatively low.

This stands in contrast to substances like alcohol and opioids, which are associated with a higher risk of dependence, overdose, and negative health consequences.

As public perception and policy shift towards a more evidence-based approach, it is essential to consider the comparative safety profiles of various substances to make informed decisions about their potential therapeutic applications and regulation.

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