A top federal health official is again touting the therapeutic “promise” of psychedelics such as psilocybin and MDMA—though she says the drugs’ Schedule I status remains a research barrier to scientifically validating their efficacy.
In a blog post this month, National Institution on Drug Abuse (NIDA) Director Nora Volkow said the “potential use of psychedelics in the treatment of various mental health conditions has made these drugs a hot area of scientific research, as well as growing public interest.”
NIDA, as well as other agencies such as the Food and Drug Administration (FDA), have been particularly interested in tapping into the therapeutic potential of ketamine, psilocybin and MDMA—each of which are undergoing trials that could pave the path to their broader accessibility to patients with serious mental health conditions.
These psychedelics “represent a potential paradigm shift in the way we address substance use disorders,” Volkow said, caveating that “there is much we still do not know about these drugs, the way they work, and how to administer them, and there is danger of the hype getting out ahead of the science.”
The director said the “promise of psychedelic compounds likely centers on their ability to promote rapid neural rewiring,” which “may explain these compounds’ relatively long-lasting effects, even with just one or a few administrations.”
“What is needed is sound scientific research including clinical trials that can substantiate therapeutic efficacy, duration, and safety in large numbers of participants,” she said, adding that interest in exploring psychedelic medicine “goes back several decades.” Volkow pointed out that the founder of Alcoholics Anonymous said his participation in LSD experiments in the 1950s informed the organization’s 12-step recovery process.
“Since then, there have been many anecdotal reports of people beating substance use disorders using psychedelics, and experimental studies are lending some support to those claims, especially for alcohol use disorder,” she said.
“However, there are many challenges to studying psychedelics in clinical trials,” Volkow said. That includes “administrative challenges for researchers of some psychedelics like psilocybin resulting from their Schedule I status.”
Volkow has long criticized the placement of certain drugs, including marijuana and various psychedelics, in Schedule I of the Controlled Substances Act (CSA), which imposes unique and onerous research restrictions on scientists hoping to investigate their medical potential.
“Harnessing the brain’s natural plasticity in effecting therapeutic gains is an intuitively obvious avenue for drug development including the development of psychedelics as therapeutics, which requires a mechanistic understanding to optimally harness their benefits. The potential value of such research goes well beyond the prospect of new treatments. The profoundly meaningful experiences some people report following use of psychedelics could give neuroscientists valuable insights into meaning-making and the ability of the brain to change in a healthy direction after addiction or trauma.”
The NIDA director’s latest post ended by reiterating that conducting robust research into psychedelics “could provide insights into wellness that could augment psychiatry’s historic focus on illness and disorder.”
Volkow has repeatedly discussed her interest in psychedelics therapy, acknowledging not only the potential but the societal impact of local and state reform potentially encouraging more people to use substances such as psilocybin outside of a clinical context.
She said in 2022 that the “train has left the station” on psychedelics amid the policy reform movement. Volkow discussed the issue in an earlier interview with Marijuana Moment as well.
Meanwhile, Attorney General Pam Bondi recently missed a congressionally mandated deadline to issue guidelines for easing barriers to research on Schedule I substances such as marijuana and psychedelics.
Under legislation passed by lawmakers and signed into law by President Donald Trump last year, Bondi was supposed to publish interim rules setting out new processes for Schedule I research registration by January 16—but that has not occurred.
Earlier this month, the Drug Enforcement Administration (DEA) separately finalized quotas for legal production of controlled substances in 2026—further raising the amount of certain psychedelics that can be made for research purposes this year.
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