Top Federal Drug Official Touts Therapeutic ‘Promise’ Of Psychedelics And Slams Schedule I Research Barriers

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.”

Can psychedelics’ ability to rewire the brain translate into long-lasting
treatments for addiction and other mental illness? NIH's Dr. Nora Volkow
explores the therapeutic promise of compounds like psilocybin, MDMA, and
ketamine and why rigorous research is essential.

Read more… pic.twitter.com/TlJjDuJNe0

— NIH (@NIH) January 15, 2026

“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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Psychedelics And Slams Schedule I Research Barriers appeared first on Marijuana
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