FDA’s Draft Guidance for Psychedelic Studies
In June 2023, the FDA issued its first draft guidance on clinical trials with psychedelic drugs. The 14-page document presents non-binding guidance, or recommendations, regarding study design and other considerations for drug development programs investigating the therapeutic potential of classic psychedelics, such as psilocybin and lysergic acid diethylamide (LSD), as well as empathogens such as MDMA.
Many comments and criticisms about the FDA guidelines have been raised in the two months following its release. Some of the biggest discussion points were surrounding the number and expertise of session monitors. The FDA recommends each patient be observed by two monitors with the lead monitor having graduate level training with clinical psychotherapy expertise while the other monitor having a bachelor’s degree and at least 1 year of clinical experience. Critics have argued that having a 2:1 practitioner to patient ratio is resource intensive, which could lead to accessibility issues. Given the established safety of many of these compounds, some have suggested that Advanced Practice Registered Nurses (APRNs) should be permitted as lead monitors, while assistant monitors should include licensed registered nurses. Other commenters asked that chaplains be permitted to serve as monitors arguing “at the very least” to be assistant monitors.
Healing Breakthrough has identified that a huge bottleneck to the widespread rollout of MDMA-assisted therapy and similar therapies will be the clinical workforce in delivering it. Regarding the VA and the military, we propose that the FDA encourage studies utilizing assistant monitors consisting of Veteran peer support specialists, chaplains, or active duty service members in similar roles but who may not have bachelor’s degrees. Healing Breakthrough also agrees with Reason for Hope, The Veteran Mental Health Leadership Coalition, and other commenters that FDA’s Guidance should also encourage further research into whether group administration of MDMA or psychedelics is permissible and suggest a monitor-to-patient ratio for group treatment. This would increase cost-effectiveness, allow a greater number of patients to be treated, and create a sense of community around the therapy.