We are hearing stories about mushrooms and MDMA and see clinics advertise ketamine. We hear of friends chasing a spiritual reset. Many in America feel the weight of depression, trauma, and addiction inside families. Psychedelics sit at the center of this pressure, with hope on one side and hype on the other.

KevinMD already published multiple essays on psychedelic medicine since 2022, including pieces on what physicians need to know, prudence in psychedelic-assisted therapy, and practical patient conversations. The topic still deserves a plain language reset because most people still lack a working map for what psychedelics do, what science supports, and what safety requires.

Let’s start with definitions. The Food and Drug Administration (FDA) uses psychedelics as an umbrella term in clinical research. Classic psychedelics include agents such as psilocybin and LSD, which act on the brain serotonin system. The FDA also includes empathogens such as MDMA in this research framing, and the FDA describes these drugs as investigational products under study. Please note that all these agents are Schedule 1 under the Controlled Substances Act, meaning these have no medical utility. Ketamine sits in a different lane as a dissociative anesthetic. The FDA has approved the ketamine derivative esketamine (brand name Spravato) as a treatment for severe depression in people who do not respond to other treatments, and the label requires supervised administration in certified settings.

Public interest rises for a hard reason. Standard mental health care fails too many people. Major depression, trauma, and addiction often persist after years of treatment. Psychedelics offer a different clinical story, rapid symptom shifts in some trials, intense emotional processing, and a renewed sense of meaning for some participants.

Science supports some optimism, then science stops short. A major review in the American Journal of Psychiatry summarizes short-term controlled trial data suggesting certain psychedelics show effectiveness and safety in major depressive disorder, treatment-resistant depression, and post-traumatic stress disorder. The same review notes preliminary evidence in other conditions such as tobacco and alcohol use disorders. There are also some unresolved gaps, including short- and long-term safety, abuse liability, and uncertainty about whether the subjective psychedelic experience and the surrounding psychological support drive benefit.

Here is the part most people miss. Modern research does not treat psychedelics as a pill swap. Most studies pair a drug session with structured psychological support before and after dosing. Clinicians often call this model psychedelic-assisted therapy. Preparation shapes expectations and emotional readiness. A supervised session in a controlled setting limits environmental risk and supports emotional processing. Integration work aims to translate a peak experience into daily change. The FDA draft guidance highlights unique challenges in study design, including expectation effects, functional unblinding, and the need to standardize psychological support.

Trial design looks hard for a simple reason: Many participants recognize the active drug. Blind study methods weaken and expectation effects rise. Researchers also struggle to separate medication effects from psychotherapy effects. Regulators see these weaknesses. Last year the FDA declined to approve midomafetamine (MDMA) for the treatment of post-traumatic stress disorder. The FDA pressed for more randomized double-blind studies with blinded long-term follow-up, prespecified criteria for retreatment, and evidence of durability. The FDA also emphasized better documentation of abuse potential and called for standardized discharge readiness criteria with both psychological and physiological assessment.

Safety deserves adult language. Psychedelics do not behave like wellness supplements. The National Institute on Drug Abuse (NIDA) explains how psychedelic and dissociative drugs alter mood, thoughts, and perception, and NIDA emphasizes how effects vary with mindset and environment, often called set and setting. NIDA outlines risks including impaired judgment, panic reactions, dangerous behavior, persistent psychosis, and hallucinogen persisting perception disorder.

At the same time, research continues. In June 2025, Compass Pathways reported a late-stage trial evaluating its COMP360 psilocybin program for treatment-resistant depression achieved the primary endpoint. Peer-reviewed publication and long follow-up will decide how much trust this result deserves. States also move, with uneven guardrails. Oregon opened regulated psilocybin services in 2023, and Oregon requires licensed service centers to collect and report certain client and service center data beginning January 1, 2025. Colorado runs a Natural Medicine program with licensure pathways and public application data updates, including an update posted in December 2025. State programs respond to access pressure. Federal scheduling and FDA standards still govern broad medical adoption.

So, what do you do with this moment? Reject two lazy stories. One story calls psychedelics a cure. One story calls psychedelics a menace. Both stories waste lives. Psychedelics look like a high-intensity intervention with real upside for a subset of suffering people, and real downside for another subset. If you explore psychedelic care, demand a serious program. A serious program starts with diagnosis and screening. A serious program names exclusion criteria. A serious program monitors mental state and vital signs before discharge. The FDA spelled out discharge readiness expectations in the MDMA Complete Response Letter, with both psychological and physiological assessment. A serious program invests in integration because emotional insight without behavior changes fades fast.

This post does not serve as a green light for self-experimentation. Unsupervised use adds chaos to an already fragile mind. NIDA notes risk of dangerous behavior and injury when psychedelic or dissociative use occurs without another individual present to prevent or respond to an emergency. Research teams build guardrails for a reason.

I want a future where psychiatry offers fewer chronic prescriptions and more precision care. Psychedelic-assisted therapy stands as one candidate for depression, trauma, and addiction care, within disciplined science and accountable systems. The path runs through transparent regulation, clinician humility, and protection of people who feel desperate. You deserve honesty. Honesty includes both promise and limits.

Muhamad Aly Rifai is a nationally recognized psychiatrist, internist, and addiction medicine specialist based in the Greater Lehigh Valley, Pennsylvania. He is the founder, CEO, and chief medical officer of Blue Mountain Psychiatry, a leading multidisciplinary practice known for innovative approaches to mental health, addiction treatment, and integrated care. Dr. Rifai currently holds the prestigious Lehigh Valley Endowed Chair of Addiction Medicine, reflecting his leadership in advancing evidence-based treatments for substance use disorders.

Board-certified in psychiatry, internal medicine, addiction medicine, and consultation-liaison (psychosomatic) psychiatry, Dr. Rifai is a fellow of the American College of Physicians (FACP), the American Psychiatric Association (FAPA), and the Academy of Consultation-Liaison Psychiatry (FACLP). He is also a former president of the Lehigh Valley Psychiatric Society, where he championed access to community-based psychiatric care and physician advocacy.

A thought leader in telepsychiatry, ketamine treatment, and the intersection of medicine and mental health, Dr. Rifai frequently writes and speaks on physician justice, federal health care policy, and the ethical use of digital psychiatry.

You can learn more about Dr. Rifai through his Wikipedia page, connect with him on LinkedIn, X (formerly Twitter), Facebook, or subscribe to his YouTube channel. His podcast, The Virtual Psychiatrist, offers deeper insights into topics at the intersection of mental health and medicine. Explore all of Dr. Rifai’s platforms and resources via his Linktree.