The U.S. Food and Drug Administration (FDA) has published its first-ever guidance document on clinical trials using psychedelic drugs.

On 23 June 2023, the FDA published Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry.

The document is designed to assist researchers exploring the potential therapeutic applications of psychedelic drugs for medical conditions. It highlights fundamental considerations for researchers investigating psychedelic therapy for treatment of medical conditions such as psychiatric or substance use disorders.

This marks an important milestone as it is the FDA's first official guidance regarding clinical trials involving psychedelics.

An FDA-endorsed framework for psychedelic research is crucial if accessibility to drugs like psilocybin and MDMA is to expand from clinical research trials into mainstream medical treatment.

In this article, we delve into the details of the document and its implications for the future of psychedelic research.


Psychedelic drugs have garnered increasing attention in recent years due to their potential therapeutic benefits. Researchers have been investigating their efficacy in treating conditions including anxiety, depression and post-traumatic stress disorder (PTSD).

Last year, mental healthcare company Compass Pathways reported encouraging results from its Phase 2 trial demonstrating the potential of psilocybin therapy in treatment-resistant depression. The largest ever study of its kind, it is now in Phase 3 trials.

However, conducting clinical studies on psychedelics presents unique challenges that necessitate careful consideration to accurately evaluate their safety and efficacy.


The primary objective of the FDA draft guidance is to provide researchers with valuable insights and recommendations regarding study design and other crucial factors when developing medications that incorporate psychedelics.

Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said:

β€œPsychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies."

The document specifically focuses on classic psychedelics such as psilocybin and lysergic acid diethylamide (LSD), but it also covers "entactogens" or "empathogens" like methylenedioxymethamphetamine (MDMA).


The draft guidance highlights several important considerations throughout the drug development process. These include trial conduct, data collection, subject safety and the requirements for a new drug application.

The psychoactive nature of compounds such as psilocybin and LSD can induce mood and cognitive changes as well as hallucinations. The FDA said that this raises concerns about potential drug abuse, making drug safety a crucial issue that necessitates robust measures to prevent misuse during clinical development.

For psychedelics currently classified as Schedule I controlled substances, the draft guidance stresses the importance of compliance with applicable Drug Enforcement Administration regulatory requirements when conducting investigations under an Investigational New Drug Application.


While the evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for any other drug, there are unique factors that investigators must consider when designing clinical trials involving psychedelics. Farchione said:

β€œBy publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications."

The draft guidance acknowledges the role of psychotherapy in psychedelic drug development and emphasises the need for safety monitoring throughout the process. It also highlights the significance of characterising dose-response relationships and determining the durability of any treatment effects.


The FDA is actively seeking public input on the draft guidance, recognising the importance of gathering diverse perspectives and expertise to inform its decision-making process.

Stakeholders and interested parties are encouraged to submit comments within 60 days to ensure that the agency considers their input. The guidance is out for public comment until 23 August 2023.

With the opportunity for public input, the FDA will hopefully ensure a collaborative approach continues to shape the future of psychedelic therapeutics.


The release of this draft guidance by the FDA signifies a significant step forward for psychedelic research in the U.S. It demonstrates the recognition of the therapeutic potential of these substances and the commitment to establish a framework that enables rigorous and well-controlled clinical trials.

By providing researchers with guidance and addressing unique considerations associated with psychedelics, the FDA is moving towards fostering an environment that may lead to groundbreaking advancements in the treatment of mental health disorders.

This development brings us one step closer to unlocking the transformative possibilities of psychedelic substances and offers hope for individuals suffering from various medical conditions.


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Main image: Artwork by Do-Ho Suh at the U.S. Food and Drug Administration building at Silver Spring, Maryland. Credit: Carol M. Highsmith / Wikimedia Commons