Federal Government Picks Wisconsin Lab to Research Psychedelic Drugs

Psilocybin cubensis mushroom. Photo by Kristie Gianopulos. (CC BY 2.0).

A Wisconsin-based medical research lab is one of just three organizations nationwide the federal government has tapped to move forward on research into psychedelic medications.

After an April executive order from the White House intended to fast-track that research, the Madison-area nonprofit Usona Institute received a voucher from the U.S. Department of Health and Human Services for its research into treating major depression with psilocybin — the psychoactive component found in magic mushrooms.

Those vouchers are designed to speed up the federal review process by the Food and Drug Administration, with a goal of getting such treatments to market faster. The voucher reduces the review time from a typical six to 10 months down to one or two months.

“I can’t think of anything that has been so stigmatized and yet seems to be so impactful,” said Paul Hutson, who directs the University of Wisconsin-Madison Transdisciplinary Center for Research in Psychoactive Substances, which studies how psilocybin can be used to treat anxiety, depression, substance use and post-traumatic stress disorder.

“There are things that are similarly impactful, such as vaccines that have saved millions of lives. But … I can’t think of anything quite so stigmatized that is now given this validation,” he added.

Hutson says the April 18 order could result in drugs from Usona and elsewhere being approved by the end of this year.

But that speed that doesn’t necessarily mean patients will start receiving those medications right away.

“There are a lot of questions that we don’t yet know the answers to, in terms of what the FDA is going to impose in the use of these drugs, and then how do we adapt to that” in finding distribution and facilitating the treatments, he said.

The actual distribution of such drugs, which are still classified as Schedule I, will need to be figured out, he said. By federal designation, Schedule I drugs have no accepted medical use.

Other questions, Hutson said, will include which pharmacies would be permitted to carry the drugs; how doctors will determine which patients will be given the treatments; and how insurance will cover these kinds of drugs.

And there will need to be a process for treatment, which in Hutson’s labs includes multiple people monitoring a patient’s usage over the course of six to eight hours, plus check-ins and counseling afterward. That will mean professionals will need to be trained to deliver these therapies — and Hutson said there are unanswered questions about the capacity of mental health providers to meet that new need.

In a statement following the signing of the executive order, HHS Secretary Robert F. Kennedy Jr. lauded the possible mental health benefits of psychedelic treatments, especially for military veterans.

Kennedy has long been a champion of such treatments, particularly as an alternative to traditional pharmaceutical interventions.

But Hutson said that, for the dozen or so years that this has been his field, the federal government has been supportive of this research in general.

“I think that this does indicate an endorsement, if you will, of this as an exciting new field in mental health care,” he said.

The Usona Institute has been recognized as a leading research institute into the mental health benefits of psychoactive drugs. And they’ve partnered with the UW-Madison to conduct some of their research. The university, too, has been a leader in researching how — and why — psilocybin appears to be effective in treating depression. Wisconsin scientists have also conducted dozens of clinical trials about using the drug.

Researchers at UW-Madison have also seen promising results using psychedelics to treat substance use disorders.

In a statement, a Usona spokesperson said the organization is “deeply grateful” for the recognition.

Compass Pathways, based in the U.K, also received a voucher for the use of psilocybin for treatment-resistant depression, and Transcend Therapeutics, based in New York, received one to study methylone as a treatment for PTSD.

The executive order also makes other changes, including allowing for the study of how ibogaine — a hallucinogen harvested from a plant found in Central Africa — could be used to treat alcohol-use disorder.

Wisconsin lab tapped to research psychedelic drug as mental health treatment was originally published by Wisconsin Public Radio.