Psychedelic Medicine: Developments, Evaluations, and Political Enthusiasm

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There has been a growing interest in the potential of psychedelic medicines, with pharmaceutical companies heavily investing in integrating these agents into healthcare, with increasing support from various stakeholders and both parties in the U.S. Congress¹. According to an article from Politico, psychedelics are gaining new resonance 56 years after psychologist Timothy Leary, PhD, urged 30,000 hippies in San Francisco’s Golden Gate Park to “turn on, tune in and drop out.” In modern times, psychedelic medicines have shown considerable promise in helping to heal intractable psychic wounds².

Back in June, the FDA issued a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions, including psychiatric or substance use disorders (SUD). Aiming to inform for proper drug development, the agency acknowledged the growing interest in recent years, especially for conditions such as depression, post-traumatic stress disorder (PTSD), and SUD. Despite this, investigators found that designing clinical studies to evaluate the safety and effectiveness of these compounds comes with a great deal of challenges that require caution and closely monitored consideration³.

“Psychedelic 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,” said Tiffany Farchione, MD, director, division of psychiatry, FDA’s Center for Drug Evaluation and Research. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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.”³

House Democrats such as Alexandria Ocasio-Cortez of New York and Lou Correa of California, and Republicans Dan Crenshaw of Texas and Jack Bergman of Michigan have thrown their full support behind the venture. The House included an appropriations bill focused on the Department of Veteran Affairs (VA) that would require further evaluation on psychedelic medications².

Rep. Morgan Luttrell, a former Navy SEAL, believes that psychedelics and therapy were instrumental to overcoming trauma after his helicopter went down during a 2009 training mission.²

“The results that are coming out are just groundbreaking — earth-shattering,” he stated in an interview with Politico. “D.C. actually is getting their head around it.”²

In November 2022, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), revealed that it successfully completed its second Phase 3 trial on Methyl​enedioxy​methamphetamine (MDMA) as a treatment for PTSD. Considered the last hurdle before applying for FDA approval, MAPS stated that its findings demonstrated significant improvements in symptoms 18 weeks after the first dose. According to the company, the drug could be approved as soon as 2024 if all goes well.⁴

In June 2023, the FDA has approved a clinical trial investigating an MDMA investigational medical product (IMP; LaNeo MDMA, PharmAla) in 40 mg capsules. The trial (NCT05770375) will examine the use of the novel therapy to assess its tolerability in patients with schizophrenia. The trial will also analyze the use of MDMA to treat asociality, which is a symptom of schizophrenia that may cause significant functional impairment. Whereas some the symptoms of schizophrenia can be treated with antipsychotics, there are currently no effective treatments for asociality.⁵

While there have been multiple reports of positive results, the FDA has concerns as well with the use of psychedelic medications. Considered controversial, the federal agency recommends the inclusion of psychological support in psychedelic treatment. As a result, there are concerns about how different personnel providing support might affect patient-clinician rapport and treatment outcomes.^1,3

In a study published by The New England Journal of Medicine, the authors argue that there is a need for expanding the amount of eligible clinician monitors, such as chaplains and nurses with expertise critical care, hospice, emergency medicine, and anesthesia. They suggest that the expansion could address the anticipated shortage of clinicians in the field and enhance the diversity of the workforce.¹

Some states have already supported the use of psychedelics, with Oregon legalizing psilocybin on New Year’s Day for adults under the supervision of licensed facilitators. Colorado has recently done the same, with additional legislation currently on the table in multiple states.⁴

Some professionals believe that there needs to be more research before expanding the use of these drugs. They emphasize the importance of rigorous research on psychological support, adverse events, and clinician credentials to improve the evaluation of psychedelic medicine, calling for an open-minded approach from the FDA to revisit these issues based on evolving evidence.¹

References

1. How Should the FDA Evaluate Psychedelic Medicine? The New England Journal of Medicine. Accessed November 8, 2023.

2. We’re on the cusp of another psychedelic era. But this time Washington is along for the ride. Politico. August 12, 2023. Accessed November 8, 2023. https://www.politico.com/news/2023/08/12/medical-psychedelic-drugs-congress-00110851

3. FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs. FDA. June 23, 2023. Accessed November 8, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs

4. Psychedelics May Be Part of U.S. Medicine Sooner Than You Think. Time. Updated February 9, 2023. Accessed November 9, 2023. https://time.com/6253702/psychedelics-psilocybin-mdma-legalization/

5. NIH. Tolerability of MDMA in Schizophrenia (TMS). ClinicalTrials.gov. Updated May 10, 2023. Accessed November 9, 2023. https://clinicaltrials.gov/ct2/show/NCT05770375