Psychedelic-assisted therapy offers hope, but faces FDA hurdles

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Aaron Martin struggled with deep depression for years that, at the worst moments, had him considering suicide.

“I was coping with surviving, but I was using that by being addicted to work, nicotine, alcohol, all of which, just more or less numb me out,” Martin said in an interview on River to River . “And really was hiding who I was and repressing feelings, and kind of just acting like this AI robot, which made it impossible to connect deeply with those I love most.”

After trying conventional therapy and medications without getting the results he needed, his wife researched, and he pursued, using psychedelics as medicine.

A life changing treatment

Martin is a financial manager from the St. Louis area. He says that as a white man in his early 50s with a white-collar job, he was lucky to be able to seek out psychedelic treatment abroad after “ten or 11 months of me deliberating and working through my fears and my stigma around psychedelic medicine.”

Martin traveled to Costa Rica for seven days to receive the treatment in a group session of 50 people taking ayahuasca . Since his first experience with psychedelics in Costa Rica, he has continued seeking out psychedelics in one-on-one sessions. He said that he wouldn’t recommend others seek out a large group session to start with like he did his first time, because he didn’t have the one-on-one counseling to tailor the experience to his issues. But he noted that the experience in Costa Rica gave him crucial time and made him want to keep working to improve his mental health.

“At the time... where I was, it bought me valuable time, which is what I needed.”

None of his psychedelic trips have been the same, but he said drugs like psilocybin , MDMA and ayahuasca have given him new insights into the emotional walls he put up in his life.

“The walls were so thick that it would allow me to see cracks in these walls and get glimpses of truth,” he said.

As a result of his continued experiences with psychedelic drugs and tailored counseling, Martin said he has been able to give up nicotine after 30 years, and he's greatly reduce his alcohol consumption. Martin said these treatments have saved his life.

“My experience with psychedelic medicine allowed me to find a direct path to hope.”

But, Martin's treatment is unconventional, and in the U.S. isn't uniformly legal, though there are ongoing ballot efforts and requests for regulatory approval for certain hallucinogenic therapies.

FDA hits pause

The FDA recently denied approval of using MDMA to treat PTSD. MDMA, commonly known as ecstasy or molly, is a drug with effects of both a stimulant and a psychedelic. It alters mood and causes distortion in time and perception, according to the DEA . The news from the FDA was a disappointing development both for patients wanting to access this treatment and for providers hoping to use it in a more widespread approach. And yet other medical professionals have noted that the denial may not be a bad outcome, at least for now, particularly as there was concern that there might have been bias in the study the FDA was reviewing — it had been conducted by a company that wants the MDMA treatment approved.

Dr. Michael Flaum, professor emeritus at University of Iowa Health Care, said last year there was a lot of hype about the potential for FDA approval of MDMA. He noted that this decision might be the right choice to prevent researchers from getting ahead of themselves.

“I think it is more than just this decision, but it really helps us think about how unique this treatment approach really is.”

Flaum explained that the FDA requires double-blind trials for almost all drugs to get approved. In double-blind trials neither the researchers nor the participants know who is getting the drug being tested and who is getting a placebo. However, with psychedelics, Flaum notes that that's a tough condition to meet.

“There is almost no way to do a double-blind study with a placebo and a psychedelic, because the experience is so powerful," he said.

This makes a truly nonbiased trial hard to achieve, which makes receiving FDA approval harder.

An additional wrinkle in the approval process is a technicality — the FDA is responsible for approving drugs, but medicated assisted psychotherapy is more than just a drug. It requires both the drug and a psychotherapist to guide the patient while they're under the drug's influence.

"This raises a question for how the approval is ever going to move forward, because we are asking them to approve something where the FDA is not the agency that approves psychotherapies," Flaum said.

It’s not clear how the FDA will move forward in addressing that concern. Candida Maurer, a licensed psychologist, suggested the FDA could add therapists to their panel to evaluate psychedelic-assisted therapy.

Iowa-based research

While the FDA grapples with how to approve medicated assisted psychotherapy, Flaum and Maurer are conducting research at the University of Iowa on how psychedelic drugs could be used to treat alcoholism.

Because of the challenges of using a placebo against a psychedelic drug, the study instead uses two different drugs to see comparative effects. Research subjects with moderate to severe alcohol issues are given a dose of psilocybin or ketamine . This allows them to compare the effects of the psychedelic drug to another drug with known effects to compare the differences. Neither the patients nor the researchers know who gets which drug.

Flaum said the researchers are finishing a small pilot project to explore if the study is feasible and what it’s like for the patients.

"What we've learned is we very much can do this. I just came from an exit interview of a patient who just completed the study. He had nothing but good things to say about it.”

Flaum said one theory of psychedelics proposes that using the drugs can allow the brain to change deeply entrenched pathways and patterns of thinking, which creates the opportunity to build new pathways that essentially overwrite the existing ones.

A thoughtful approach to psychedelics

Researchers say these drugs are not addictive, although they do have the potential to be unsafe. They would not give these drugs to a person with a difficult heart condition or someone who could be susceptible to psychotic disorders, such as someone with a family history of schizophrenia or severe bipolar disorder.

They also do not endorse using psychedelic drugs recreationally to self-medicate.

“It is the combination of the medicine with the psychotherapy.” Maurer said. “The medicine by itself, you can have a wonderful time, you can have a horrible time, but it alone is not going to take you where you need to go, because people tend to avoid the difficult areas if they can, and if they can't, then they have a bad trip. So it's really important to have people who are trained doing the psychotherapy.”

Those interested in participating in the university's study can fill out a screening questionnaire to see if they may qualify.

To hear this conversation, listen to River to River, hosted by Ben Kieffer . Caitlin Troutman produced this episode.