The Substance Abuse and Mental Health Services Administration (SAMHSA) published a new report on current concerns regarding research, regulation, and policy of psychedelics as medicine.
While there is a significant amount of information included in the report, SAMHSA provided policy considerations for state lawmakers, encouraging them to consider planning now for the fiscal, legal, and operational implications of potential FDA-approved psychedelic therapies, including any Medicaid coverage obligations.
The delivery of such policy recommendations from a federal agency could indicate the accelerating progression of psychedelic therapy may continue, especially as this aligns with recent activity from the current administration.
The report includes detailed information on current psychedelic access pathways and emerging state models, which likely informed SAMHSA’s policy recommendations. Additional policy recommendations noted by SAMHSA include:
- Investing in research examining psychedelics in populations representative of the public mental health system, particularly those with serious mental illness, co-occurring disorders, and complex trauma
- Developing oversight frameworks, including credentialing standards, safety protocols, informed consent processes, and complaint mechanisms proactively, before psychedelic therapies are formally made available for state system service recipients
- Monitoring unregulated psychedelic use among various populations and preparing educational materials for providers and consumers about known risks and benefits
- Engaging with the federal regulatory process and coordinating across agencies so that relevant decision-makers in states are informed and prepared when psychedelic policy proposals arise
On the more clinical side of things, the report notes that currently known contraindications and precautions for psychedelics may include:
- Psychiatric disorders such as schizophrenia, schizoaffective disorder, and bipolar disorder
- Cardiovascular conditions
- Use in combination with lithium, which can cause increased of seizures and adverse psychological effects
- Use in combination with SSRI and MAOI medications, which can carry a risk of serotonin syndrome
Additionally, the report provides an overview of the current clinical trial progress of various psychedelics. This includes:
- Psilocybin, which has completed two Phase 3 clinical trials for treatment-resistant depression (TRD), along with a Phase 3 trial for major depressive disorder, and completed Phase 2 trials for alcohol use disorder (AUD), smoking cessation, and cocaine use disorder
- Deuterated psilocin (deupsilocin), which is currently in Phase 3 clinical trials for MDD in patients with inadequate response to current antidepressants, with topline results expected in 2026
- 4-OH-DiPT prodrug (luvesilocin), which will soon begin Phase 3 clinical trials for postpartum depression (PPD)
- LSD (lysrgide), which is underdoing two Phase 3 clinical trials for generalized anxiety disorder, with topline data expected in 2026
- MDMA, which completed two Phase 3 clinical trials for the treatment of PTSD,
- 5-MeO-DMT (mebufotenin), which is expected to begin Phase 3 clinical trials soon for TRD and AUD
- Ketamine and esketamine, which was approved in 2019 by the FDA for TRD and later MDD
- Ibogaine and noribogaine. While ibogaine has not been cleared for clinical trials, noribogaine, an active metabolite of ibogaine, will soon begin its first clinical trial for AUD
- DMT, which has completed Phase 2 clinical trials for the treatment of depression, MDD, and social anxiety disorder
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