Ethical Considerations Regarding Psychedelics for Clinical Pain Research.

Psychedelics, substances with a long history of cultural and medicinal use, are experiencing a resurgence in clinical research, particularly in psychiatry. Despite their classification as Schedule I drugs, recent studies suggest therapeutic potential, particularly in treating refractory depression. With chronic pain representing a major health concern and with few non-opioid treatment options available, psychedelics are being explored as alternative treatment modalities. The National Institutes of Health (NIH) now funds psychedelic research, marking a shift from previous decades of limited funding. However, ethical considerations loom large. Vulnerable populations, such as those with chronic pain that impairs their autonomy, require careful consideration by researchers of risks and benefits. Additionally, researchers and interested entities must navigate complex regulatory landscapes involving the United States Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) when considering pursuing possible research. Furthermore, transparent collaboration among stakeholders-patients, researchers, and regulatory bodies-is crucial for participant safety and successful research. Although a number of ethical approaches can be taken, we posit that stakeholders consider utilizing principal-based research ethics, comprised of the principles of autonomy, beneficence, justice, and nonmaleficence, to guide the process. Ultimately, balancing therapeutic promise with ethical integrity is paramount. Careful planning, collaboration, and adherence to ethical principles can increase the likelihood that psychedelic research in chronic pain management progresses responsibly, offering hope for patients while safeguarding their well-being.