The U.S. Food and Drug Administration (FDA) has made a groundbreaking move by releasing a draft guidance on clinical trials with psychedelics.
The document, the first of its kind, provides key insights for researchers looking into the therapeutic potential of psychedelics for treating various medical conditions, including psychiatric or substance use disorders.
There has been a surge in interest in the therapeutic capabilities of psychedelic drugs recently.
Researchers are exploring their potential use in managing conditions such as depression, post-traumatic stress disorder, and substance use disorders, among others.
However, the unique challenges associated with structuring clinical trials to evaluate the safety and efficiency of these compounds necessitate careful consideration.
According to Tiffany Farchione, M.D., director of the Division of Psychiatry at the FDA Center for Drug Evaluation and Research, psychedelics have shown preliminary promise for treating mood, anxiety, and substance use disorders.
Despite this, she asserts that these drugs remain under investigation.
“Sponsors looking into the therapeutic potential of these drugs should factor in their unique characteristics when designing clinical studies,” she stated.
The purpose of releasing this draft guidance, according to Farchione, is to enlighten researchers on the challenges that come with designing psychedelic drug development programs, and offer ways to navigate these hurdles.
The draft guidance includes advice to researchers on study design and other aspects involved in developing medications that contain psychedelics.
Within the document it refers to “classic psychedelics” such as psilocybin and LSD that influence the brain’s serotonin system.
The guidelines describe essential considerations throughout the drug development process, including trial conduct, data collection, subject safety, and new drug application requirements.
It specifically points out the potential for abuse of psychedelic drugs due to their psychoactive effects, which may trigger mood and cognitive changes, as well as hallucinations.
As such, the FDA stresses the need to put sufficient safety measures in place to prevent misuse during clinical development.
The FDA points out that the bar for establishing effectiveness for psychedelics is no different from that for all other drugs.
Nonetheless, there are unique factors investigators must address when designing their clinical trials if they want the trials to be considered adequate and well-controlled.
The draft guidance also covers the role of psychotherapy in psychedelic drug development, safety monitoring considerations, and the importance of determining dose-response and the durability of any treatment effect.
The FDA is inviting the public to offer their comments on the draft guidance within a 60-day period to ensure they are taken into consideration.
