Psilocybin Therapy Trials

The Sanctuary Wellness Institute does not offer Psilocybin Therapy. This web page is meant for informational use only.

Introduction

Psilocybin therapy is an emerging intervention for various chronic health and behavioral disorders. The growing body of research is leading to a shift in legislative and regulatory stances on psychedelics.

Initial results have been highly promising. Based on their strength, the Food and Drug Administration deemed psilocybin a breakthrough therapy, opening the door for deeper study. Today, investigators are holding clinical trials nationwide to study the therapeutic effects of various types of psychedelic substances.

This step is critical for the evolution of psilocybin therapy. Clinical trials are the gold standard of medical research. They are vital for achieving legislative reform (such as broader FDA approval) that will grant broader access and establish effective treatment protocols.

This article covers the history of psychedelic research, the nature of clinical trials, and questions you may have about the status of psychedelic therapy. Learning about the body of scholarship and where it is headed will help you follow emerging trends and appreciate psilocybin’s mental health benefits.

History of Psychedelic Research

The first studies of psychedelics began in the 1940s with LSD. Western scientists first documented Psilocybe mushrooms in the 1950s, and investigations into psilocybin quickly started.

Researchers at Harvard and other institutions set out to assess how the compound affected the mind and explore possible clinical uses. Public sentiment shifted in the 1960s, leading to a prohibition of psilocybin in 1970.

This criminalization halted advanced clinical research and in-depth study, but a dedicated group of scientists maximized their investigations within the bounds of U.S. drug policy. Throughout the balance of the 20th century, scientists deepened their understanding of psilocybin’s chemical composition and how it interacted with the brain.

As scientific understanding of chronic disease and neurochemistry grew, psychedelics reemerged as a potential treatment option in the early 2000s. The current revolution started in 1999 when Dr. Roland Griffiths established a research program focused on psilocybin at Johns Hopkins University.

Researchers in the U.S. and Europe began clinical trials, focusing on severe treatment-resistant depression and depression in terminal cancer cases. In 2020, based on the strong results of a clinical trial, the FDA deemed psilocybin a breakthrough therapy. This designation legitimized the intervention in the eyes of many and allowed further research.

Psilocybin Therapeutic Uses

While researchers are still unlocking the full therapeutic potential, psilocybin is already proving effective. Scientists now hypothesize that the mind-opening effects and novel interconnectivity generated by psilocybin can treat chronic conditions more effectively and with fewer side effects than traditional pharmacological products like antidepressants and opioids.

Many healthcare professionals believe that psilocybin treatment can diminish or even eliminate depressive symptoms in patients with major depressive disorder. Psilocybin’s engagement with serotonin receptors and ability to rewire neural pathways provides an uplifting effect that can be life-changing for those dealing with major depression.

Research studies examining the use of psychedelic drugs like magic mushrooms, MDMA, and DMT to treat substance use disorders (such as alcohol use disorder), suicidal ideation, post-traumatic stress disorder, anxiety disorders, and compulsive behaviors are also being conducted with healthy volunteers. Many of them are double-blind, randomized, and/or placebo-controlled.

Neuroscience researchers believe that the state of openness induced by psilocybin can help patients develop new behavioral patterns, moving from potentially harmful tendencies to more desirable outcomes.

Other researchers are exploring psilocybin-assisted therapy as a potential treatment for neurodegenerative disorders affecting cognition, memory, and movement. Psilocybin activates disparate parts of the brain and increases communication. Forging new pathways may treat dementia, Alzheimer’s disease, and Parkinson’s disease.

With these psychedelic studies, neurologists are also assessing psilocybin’s ability to manage epilepsy, migraines, and cluster headaches. They theorize that enhancing neural connectivity may bypass the anatomical abnormalities that cause these conditions.

What is Psilocybin Therapy?

Psilocybin therapy is a growing discipline with many possible applications. Typically, the intervention involves administering a dose of psilocybin in a safe clinical environment. Practitioners strive to create a sense of comfort and security as the mind-opening effects of psilocybin take hold.

Depending on the treated condition, the practitioner will employ therapeutic techniques to talk the patient through their experience. This treatment could involve guiding them to certain emotions or thoughts or focusing on establishing new behavioral patterns.

The session involves gently guiding the patient through their psychedelic experience while monitoring for any potential adverse reaction. The openness to new thoughts and altered perception enhances the effects of talk therapy as the neuroplasticity induced by psilocybin makes the mind more receptive.

What Happens During a Psilocybin Therapy Clinical Trial?

A clinical trial is a scientific investigation researchers use to prove a specific hypothesis. Each study sets out to assess the effectiveness of psilocybin for a particular disorder or assess the impact of the compound on healthy participants.

First, researchers will conduct an intake interview and collect health information to ensure applicants are appropriate candidates for the trial. Depending on the type of investigation, they may sort enrollees into an experimental and a control group. One group undergoes the treatment, and one group receives a placebo or sham therapy.

Participants do not know which group they are in during the trial. Applicants will then attend follow-up appointments, complete a symptom journal, or carry out other tasks designed to provide the researchers with valuable data.

The federal government and academic institutions tightly regulate clinical trials to ensure patient safety and privacy. Studies can vary in length, lasting up to years, depending on their scope and the nature of the hypothesis.

How to Participate in a Psilocybin Therapy Clinical Trial

If you wish to participate in a clinical trial, the first step is to locate actively recruiting studies and confirm your eligibility. The National Institute of Health has a searchable database that you can use to find clinical trials.

After browsing selections, you must verify your health condition meets the criteria. Then confirm that you meet the age and demographic requirements. You can then apply to the trial.

The research team will conduct a screening interview to verify your eligibility and suitability if you are selected. The researchers will explain the rules, safety protocols, and obligations that apply to participants.

Trials may not be available near your home due to the legal status of psilocybin and the location of institutions conducting research.

FAQ

Are there clinical trials for psilocybin?

Yes. As of January 2023, the NIH database lists over 100 trials for psilocybin in various statuses, from planning to completion. As the therapy gains broader acceptance and legality expands, investigators will conduct more studies.

When will psilocybin be approved?

It is too early to predict when psilocybin will gain FDA approval. First, researchers must provide strong evidence of effectiveness based on successful clinical trials.

However, the initial returns have been so promising that the FDA granted the treatment breakthrough status. In addition, Colorado and Oregon have legalized the personal use of psilocybin. Nine other states are formally exploring therapeutic applications.

How much psilocybin is used in clinical trials?

It depends on the trial. In general, dosing ranges from 10 mg to 25 mg. The disorder and type of therapy determine the dose. You can ask the researchers all your questions during the recruitment process.

Is psilocybin still a Schedule I drug?

Yes. Despite the research gains and rising profile, psilocybin remains federally prohibited and a Schedule I narcotic. Psilocybin is legal in Colorado and Oregon, but they are still establishing treatment programs.

Ann Arbor, Cambridge, Santa Cruz, Seattle, Somerville, and the District of Columbia decriminalized possession for personal use.

What psychedelics are legal in the U.S.?

The only legal psychedelic in the U.S. is ketamine. Clinicians prescribe it as a treatment for severe depression, PTSD, and other emotional disorders. Psilocybin, LSD, ayahuasca, and other psychoactive compounds remain illegal across most of the country. Possession for personal use can lead to fines and jail time.

As clinical trials unfold, lawmakers will have more evidence for decriminalization and legalization. Formal treatment programs are further off, but multiple states have task forces studying their viability.