Psychedelics have re-emerged in this century as a popular substance to use by people of different ages and socio-economic status. The reasons for use vary between recreational and treatment focused. The Controlled Substance Act of 1970, signed by then President Nixon, created a ban on the use of these substances in the United States but advocates have found reason to revisit the therapeutic benefits of psychedelics in both physical and behavioral healthcare settings but at what cost. Is the research conducted a true representation of potential consumers? Is history repeating itself in current research practices? This chapter seeks to take a social justice approach to understanding the modern-day implementation of Psychedelic-Assisted Psychotherapy as a modality of treatment in community based mental health clinics with a special focus on treating race-based trauma experienced by Black and Indigenous people of color (BIPOC). Emerging research reveals Psychedelic-Assisted Psychotherapy as an effective form of treatment for common mental health conditions such as depression and post-traumatic stress disorder (PTSD). However, in effort to gain better understanding of the outcome scholars have noted and uncovered inequities that exist within the research and implementation of treatment. 


  1. What distinguishes psychedelic-assisted psychotherapy from traditional pharmacological treatment?
  2. How does the concept of “set and setting” relate to trauma-informed practice?
  3. What ethical concerns arise when integrating psychedelic therapies into community systems?

U.S. Food and Drug Administration. (2026). Psychedelic drugs: Considerations for clinical investigations—Guidance for industry. This final guidance, issued in July 2026, addresses trial design, safety monitoring, psychotherapy-related considerations, informed consent, and other issues unique to the clinical development of psychedelic drugs. It replaces the FDA’s 2023 draft guidance.

The FDA also maintains a central Psychedelic Drugs information page containing regulatory guidance, public meetings, research initiatives, and federal updates.

  • Oregon: Oregon Health Authority. Oregon Psilocybin Services. Oregon licenses and regulates psilocybin manufacturers, testing laboratories, facilitators, and service centers. Regulated services began becoming available in 2023.
  • Colorado: Colorado Department of Regulatory Agencies. Natural Medicine Program. This site provides current licensing, rules, applications, advisory-board materials, and regulatory updates for Colorado’s natural-medicine framework.
  • New Mexico: New Mexico Department of Health. Medical Psilocybin Program. The Medical Psilocybin Act took effect in June 2025. The state is developing a medically integrated program for qualifying conditions, with implementation and initial patient enrollment planned by December 31, 2026.
  • National policy overview: RAND Corporation. Considering psilocybin legalization: Insights for New York and other jurisdictions. This policy analysis distinguishes legalization, decriminalization, enforcement deprioritization, supervised-use models, and personal cultivation or sharing models.

Readers should consult current state agency and legislative websites, because proposed bills, administrative regulations, local restrictions, and implementation dates change frequently.

Substance Abuse and Mental Health Services Administration. (2026). Trauma-informed approaches and programs. SAMHSA emphasizes safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, voice, and choice. Psychedelic services require particular attention to informed consent, power differences, participant vulnerability, cultural responsiveness, boundaries, and the prevention of retraumatization.

Cross-reference: See Chapter 5 “Immigration Trauma” for application of a trauma-informed lens and Chapter 12 “Structural Racism” for examination of equity, access, cultural safety, research representation, and institutional power.


Multidisciplinary Association for Psychedelic Studies. MDMA research resources. The collection includes research reports, investigator materials, treatment manuals, safety resources, and an archive of MDMA-related scientific literature. Because MAPS has sponsored and advocated for MDMA research, these materials should be read alongside independent peer-reviewed studies and FDA regulatory documents.

  • Barber, G. S., & Dike, C. C. (2023). Ethical and practical considerations for the use of psychedelics in psychiatry. Psychiatric Services, 74(8), 838–846. The article addresses informed consent, clinician competence, treatment boundaries, commercial pressures, equitable access, cultural concerns, and the increased vulnerability of patients during psychedelic experiences.
  • Schonholz, S. M., Appel, J. M., Bursztajn, H. J., Nair, M., & Macintyre, M. R. (2024). Legal and ethics concerns of psilocybin as medicine. Journal of the American Academy of Psychiatry and the Law, 52(4), 477–485. The authors examine evolving regulation, professional standards, informed consent, potential liability, and questions concerning a patient’s right to access an emerging treatment.
  • Smith, W. R., & Sisti, D. (2021). Ethics and ego dissolution: The case of psilocybin. Journal of Medical Ethics, 47(12), 807–814. The article considers enhanced informed consent, possible changes in values or personality, trauma re-exposure, suggestibility, therapeutic touch, and the ethical significance of profound alterations in self-experience.