Federal regulators fast-tracked approval of psychedelic drugs to treat some of the nation’s most stubborn mental health disorders, reopening a debate that has lingered since the counterculture era: Are hallucinogens dangerous drugs of abuse, breakthrough medicines, or both?

The U.S. Food and Drug Administration announced in April that it would accelerate reviews of several psychedelic compounds aimed at treating severe depression, post-traumatic stress disorder and alcoholism — conditions that often resist conventional treatments. The agency granted fast-track incentives for companies studying psilocybin for treatment-resistant depression and methylone for PTSD, while also approving an early-stage clinical study of ibogaine, a psychoactive substance derived from the African iboga plant, for alcoholism.

The move reflects a dramatic shift in federal thinking. Once grouped with harmful drugs like heroin and cocaine with a high risk of abuse and no medical use, psychedelics are increasingly being treated as a distinct class of substances with unusually low addiction potential and growing evidence of therapeutic value.

“Depression and PTSD also result in death, quite often, especially for veterans,” said Andrew Coop, a professor at the University of Maryland School of Pharmacy and chair of Maryland’s Task Force on Responsible Use of Natural Psychedelic Substances. Coop said the FDA’s actions effectively extend a “right-to-try” philosophy — originally designed for terminal cancer patients seeking experimental drugs — to people suffering from severe psychiatric illness.

The urgency is fueled in part by the limitations of existing treatments.

Psychiatrist Dr. Scott Aaronson of the Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics said psychedelic therapies are drawing attention because they appear capable of helping people with extreme, treatment-resistant depression, including patients who experience suicidal thoughts daily.

“These are people who have often exhausted every other option,” Aaronson said.

Yet the emerging science suggests psychedelic drugs may not resemble traditional psychiatric medications at all, he said. Unlike antidepressants, which regulate neurochemistry over time, psychedelics appear to temporarily increase brain connectivity and psychological flexibility, potentially creating a window in which therapy can produce lasting changes.

That distinction has created a deepening divide among researchers. One school of thought argues that the psychedelic experience itself — the hallucinations, emotional breakthroughs and altered states of consciousness commonly called “trips” — is essential to healing. Another argues that the compounds may eventually provide benefits independent of the hallucinatory experience.

A new study published May 5 in Nature Communications appears to strengthen the first argument. Researchers studying 28 psychedelic-naive participants found measurable changes in brain anatomy and function lasting from one hour to one month after a single high dose of psilocybin. Participants also reported increases in cognitive flexibility, psychological insight and well-being after one month. Importantly, researchers found that the intensity of the psychedelic experience appeared tied to the degree of benefit.

For advocates of psychedelic-assisted therapy, the findings support the idea that the drugs cannot simply be reduced to chemical mood enhancers.

“It’s more than neurochemistry,” Aaronson said. “They make the brain more amenable to change.”

But he argues the setting matters as much as the substance. Psychedelics, he said, work best in a structured therapeutic environment where patients are prepared for emotionally difficult experiences and guided afterward in processing them.

For PTSD patients, especially, sessions can involve traumatic memories resurfacing with unusual intensity. Therapists and session monitors are often trained to respond reactively rather than directing the experience itself, helping patients interpret difficult moments instead of steering them away.

“It’s a different role for the therapist than most are used to,” Aaronson said. At the same time, “it’s especially satisfying work because you can see profound gains in days and weeks rather than months and years.”

Researchers say the drugs also raise concerns.

While psychedelics are considered far less addictive than opioids or stimulants, doctors worry they may trigger psychiatric disorders in vulnerable people with family histories of schizophrenia or other psychotic illnesses.

Aaronson compared the risk to concerns surrounding heavy THC use, which some psychiatrists view as a “stress test” for latent mental illness.

That caution partly explains why federal regulators remain careful despite the accelerating momentum. In 2024, the FDA rejected an application by Lykos Therapeutics for MDMA-assisted PTSD therapy, citing concerns over study design and data reliability.

The challenge, Aaronson said, is that the nation’s drug approval system was built around predictable pharmaceutical effects, not transformative psychological experiences that are difficult to measure in conventional clinical trials. Double-blind studies — the gold standard of medical research — become complicated when patients can usually tell whether they have received a psychedelic or a placebo.

Standard depression scales may also fail to capture some of the changes patients describe, including reduced existential despair, improved relationships or a renewed sense of meaning.

“People get better in ways we don’t always measure,” Aaronson said.

The legal questions extend beyond medicine.

Maryland’s psychedelic task force is examining whether the state should eventually allow broader supervised use or even commercial sales, similar to the path to cannabis legalization. Coop said the group has recommended a cautious, stepwise approach beginning with tightly controlled therapeutic applications.

Support for that strategy appears to be growing nationally. Surveys show Americans are increasingly open to the medical use of psychedelics, particularly for veterans and patients with severe mental illness.

Still, advocates warn against moving too quickly.

“I’d like to speed up the process,” Aaronson said, “but not too much.”

©2026 The Baltimore Sun. Visit at baltimoresun.com. Distributed by Tribune Content Agency, LLC.