After decades of little research, we are now clearly in the midst of a psychedelic renaissance. The proliferation of clinical trials investigating psychedelic substances has led to a burgeoning industry projected to reach $10.75 billion by 2027. MDMA and psilocybin were both granted Breakthrough Therapy designations by the US Food and Drug Administration (FDA) after phase 2 studies indicated significant improvements over existing medications (Feduccia et al., 2019). Several other psychoactive compounds, including LSD, mescaline, and 5-MeO-DMT, are moving through drug development pipelines.
MDMA-assisted therapy for the treatment of posttraumatic stress disorder (PTSD) is anticipated to become FDA-approved as early as 2023. A phase 3 trial of MDMA-assisted therapy found 67% of participants with chronic, severe PTSD treated with MDMA no longer met PTSD diagnostic criteria at the end of the 18 week study. Compared to a 32% response rate in the placebo group, the results are extremely promising for this difficult to treat condition (Mitchell et al., 2021).
Psilocybin, a classical psychedelic found in over 200 species of “magic mushrooms”, is under research for several types of health conditions. The drug development programs furthest along are conducting trials using synthetic psilocybin to treat major depressive disorder and treatment-resistant depression. Several studies have reported significant and long-lasting improvements in depression severity following 1-3 psilocybin administrations with psychological support or psychotherapy (Carhart-Harris et al., 2018, 2016; Griffiths et al., 2016; Ross et al., 2016). If planned phase 3 trials replicate earlier studies, then psilocybin could become available as a medicine by 2025 or 2026.
Psychedelic Treatment Approaches and Challenges
Psychedelic protocols typically involve rigorous screening and medical evaluation, preparatory therapy sessions, all-day psychedelic therapy sessions, and follow-up integration therapy. Several types of health professionals are necessary to implement these treatments. A physician is needed to assess physical health status and prescribe the medications. If a client is found suitable, then other professionals deliver the psychedelic-assisted therapies. These include therapists, nurses, psychologists, social workers, counselors, and most likely other trained paraprofessionals for supportive roles.
Importantly, psychedelics aren’t like other psychiatric medications. They require supervised administrations with a co-therapy team to ensure safety during 6 to 8 hour sessions. The psychedelic experience can be vast and varied depending on the type of substance, the setting where it is taken, and the individual’s mindset. Positive outcomes from clinical trials are attributed to the combination of the drug + therapy, which require practitioners to be skilled in navigating the psychedelic experience and providing therapy to patients in altered states of consciousness.
Because psychedelics profoundly shift cognition and emotions, patients are in a vulnerable position. Unscrupulous practitioners can take advantage of a person under influence of substances known to alter judgment and increase suggestibility(Anderson et al., 2020). Reports of sexual abuse have surfaced from both clinical trials and underground settings. These ethical challenges must be addressed to protect patients seeking treatment.
Given these new medications could hit the market in the coming years, a looming question is how will healthcare professionals be prepared to administer these treatments?
Training and Continuing Education
To administer these novel psychedelic treatments, health professionals will need to undergo training. At the moment, uncertainty surrounds who will issue accreditation and certifications for psychedelic training programs. Even so, some professionals are already investing heavily by paying steep training program costs, anywhere from $5,000 to $22,000, without assurance that these certificates will be applicable for FDA-approved psychedelic medicines or meet the standards under development.
At this time, there is no ketamine training accreditation, even though the drug is now widely prescribed off-label for mental health conditions. It’s simply up to the providers to determine what training, if any, is necessary to administer ketamine. With a drug as powerful and potentially addictive as ketamine, the lack of requirements for training is alarming, and leads to varied and unpredictable quality of care.
Health care providers who do not intend to deliver psychedelic therapies will need continuing education to be prepared to answer their patients’ questions and make referrals. In addition to changing perspectives on medical use of psychedelics, Americans are seeing increased use of psychedelics in recreational settings. Providers must be aware of potential risks and be equipped to inform their patients on harm reduction.
Embrace Change for a New Paradigm for Mental Health
These are exciting times for the mental health field. After several decades of incremental advances in treatment strategies, we stand on the precipice of a new paradigm for addressing a myriad of health conditions. But one thing is for sure, we must upskill and train health providers to competently and ethically deliver psychedelic treatments to the millions of patients who could potentially benefit. It’s not too early to start preparing. Online continuing medical education courses and full clinician training programs are available now. Even with all the unknowns, the journey has already begun for the field of psychedelic medicines.
Allison Feduccia, PhD, CEO Psychedelic Support
Dr. Allison Feduccia is the Co-Founder and CEO of Psychedelic Support, an education platform and health provider directory. She is a neuro pharmacologist interested in advancing psychedelic research and has published extensively on psychedelics and mental health from her research at UT Austin, UCSF, NIH, and MAPS.
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