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'Breakthrough therapy'? The strange trip of psychedelic research lands in Ohio

Cleveland Clinic and the Ohio State University have begun recruiting subjects to test whether LSD and psilocybin may help those with mental health disorders.


What a long, strange trip it's been for psychedelics.

Natural substances like peyote, ayahausca, and psilocybin from mushrooms were traditionally used in ancient cultures, often in religious ceremonies.  

"People did these substances — consumed these substances, in particular — and in specific sets and settings with specific guides who were trained to assist in order to attain desirable cognitive states," says Dr. Deepak Sarma, a religious studies professor at Case Western Reserve University and one who teaches a class on psychedelics and spirituality.

Fast forward to the 20th century: Science discovers 3,4-methylenedioxy-methamphetamine (MDMA) — better known as Ecstasy, a synthetic drug that alters mood and perception. Also coming into the fold is lysergic acid diethylamide, a synthetic chemical made from a substance found in ergot, which is a fungus that infects rye grain. You know it better as LSD.  

Despite extensive federal research into these substances, by the 1970s, the government begins criminalizing them.

"Psychedelics are very, very powerful in terms of how they can transform the mind and how they can make the mind malleable and how they can make people more open to things, and even then, question the things that they see," Sarma explained. "It's a real threat when people's minds get opened up and they question the structures that exist, the institutions that exist."

But now in the 21st century, depression and anxiety rates are skyrocketing. Psychedelics are getting a new look from a therapeutic standpoint, and researchers have begun testing them to see if they can help those with mental health disorders.

Already, psilocybin showed some promise for these dealing with Treatment resistant depression (TRD), and MDMA showed promise for veterans battling post-traumatic stress Disorder (PTSD). Research shows the substance opens pathways in the brain relating to memory and emotions.  

A study at Johns Hopkins University looked at psilocybin for depression. It included a preparation phase of therapy where depression patients received about eight hours of therapy, then received between one and three doses of psilicybin spread over several weeks. 

They had therapy in between those sessions and then therapy after the second psilocybin session was completed. It took about three months to complete, and researchers followed patients for a year. 

Results showed 58% were in remission at 12 months. While promising, it didn't work for everyone, and researchers can't say yet if the remission continued, but the results were promising enough to get federal notice. 

"PTSD, depression, and treatment-resistant depression have all been given breakthrough therapy status by the FDA, meaning that it's within the top 30% of leading candidates that the FDA is monitoring, meaning that the evidence is so strong that they are kind of green-lighting and fast-tracking those substances through the approval process," Dr. Alan Davis, director of The Ohio State University Center for Pyschedelic Drug Research and Education, said.

In 2020, Oregon became the first state to legalize psilocybin-assisted therapy and decriminalize possession. Colorado followed, and several states have since introduced different levels of legislation, according to Psychedelic Alpha, a website that maps legislative policy regarding these substances.

Ohio's attempt never made it to a vote.  

The conversation started years ago, with many celebrities and notables touting their use and positive mind effects they received. Green Bay Packers quarterback Aaron Rodgers described his experience with ayahuasca during a trip to Peru on the "Aubrey Marcus Podcast."

Ayahuasca is a concentrated liquid, made by prolonged heating or boiling of the Banisteriopsis caapi vine with the leaves of the Psychotria viridis shrub. The active chemical is DMT (dimethyltryptamine), and it also contains monoamine oxidase inhibitors (MAOIs).

First Nations peoples from contemporary Peru, Brazil, Colombia, and Ecuador use "aya" for religious rituals and therapeutic purposes. Rodgers said he used it to help support his "mental and spiritual health." 

"It was a very deep and meaningful couple-nights ceremony, and I came back and knew that I was never going to be the same. It gave me a deep and meaningful appreciation for life," the four-time NFL MVP added. "I had a magical experience with the sensation of feeling a hundred different hands on my body, imparting a blessing of love and forgiveness for myself and gratitude for this life from what seemed to be my ancestors."

While there's promise in the research, there's still much more research to be done.  

"Just because a recreational drug has a potential effect in one area does not make it a solution for everything," Dr. Patrick Runnels, a psychiatrist at University Hospitals Cleveland Medical Center, cautioned.

Previous clinical trials showed the treatments may only require two or three doses spread over a few weeks, but they also require intense psychotherapy and at least two trained supervisors during the proverbial trip that could last several hours.

"Usually [the supervisors are] clinical psychologists, psychiatrists, counselors, social workers who have been trained to work with populations in distress, to work with populations who have a variety of different cultural and other types of needs that are relevant to psychotherapy," Davis said.

Yet Sarma questions how one becomes credentialed to supervise, and is concerned for those who may have a more religious experience. 

"A therapist who's very familiar with, say, Christianity, how would he/she/they respond to a transformative experience of a Hindu who has what one might call a 'Hindu mystical experience'?" he asked. "Would that therapist be able to explain — or understand, for that matter — what that patient participant is experiencing?"

See all of Sarma's interview on the "Health Yeah!" podcast with Monica Robins:

Davis says at this point, the FDA does not require pastoral therapists be part of the sessions. However some centers — such as Emory University — do use spiritual counselors in part of their research. 

"The mystical experience is a component for some people, but it's not a component for everyone," Davis told 3News. "But what often happens for people is they will have deep psychological insights or new understandings, realizations about themselves or the world around them. There's this term called 'quantum change,' where it's really the pairing together of something spiritual and something insightful, and the combination of these experiences when they happen simultaneously might promote change in someone's experience of life."

Davis says this is another reason why training is so crucial for those monitoring patients, and another reason why this treatment will be expensive and limited.  

This month, Australia became the first country to formally recognize the therapeutic uses of psychedelics MDMA and psilocybin, but it will not be the last.

"We're likely within one to two years — at this point, on what I can tell — for those drugs to be approved by the FDA."

How the strange trip ventured into Ohio

Four words you never thought you’d hear: Cleveland Clinic LSD Research. But, it's happening.

This week, Cleveland Clinic began recruiting patients for a clinical trial testing whether LSD can help those suffering from generalized anxiety disorder. 

"If the results are positive, the company would seek FDA approval for LSD as as a medication," Dr. Brian Barnett, assistant professor of psychiatry and co-Director of the Treatment Resistant Depression Clinic at Cleveland Clinic, says.

The Clinic is working with MindMed, a company experienced researching the therapeutic effects of psychedelics. Here's how the trial would work:

  • Patients with generalized anxiety disorder will receive either a one-time dose of MindMed's proprietary LSD formulation (one of four different doses) or a placebo.
  • Patients will be supervised for 12 hours by two team members while listening to a pre-designed music playlist and being encouraged to wear eyeshades to focus inward.
  • The patient's anxiety scores will be assessed four weeks later to look for efficacy and the best dose for the follow-up trial if this one has promising treatment findings.
  • The study is approximately 12 weeks (eight visits), plus a screening period of up to 30 days. Visits may last between one to three hours, with the dosing session day lasting approximately 13 hours. During the dosing session day, participants will be continuously attended to by site staff to support their experience and monitor safety, and patients may be compensated for their time.

The study is looking for 10-15 participants, and those interested can call (216) 828-5471.

Anxiety disorder can be debilitating for some, causing both mental and physical symptoms from excessive worrying to heart palpitations. While medications are available, they don't work for everyone, and that's who the trial is looking for. Still, some will not qualify.

"[For] people who've been diagnosed with psychotic disorders such as schizophrenia or bipolar disorder, which can sometimes cause mania or psychosis, there's a danger there that psychedelics can exacerbate psychosis or bring about mania or psychosis in those people," Barnett explained.

But Cleveland Clinic isn’t the only place in Ohio researching psychedelics: Last year, the Ohio State University opened the Center for Psychedelic Drug Research and Education in the heart of its medical campus. It will not only study these substances; it will also train therapists how to use them. 

Davis is not just the director of the program; he's also an assistant professor in OSU's College of Social Work and an adjunct assistant professor at Johns Hopkins. He got involved in this research because he comes from a family of military veterans and understood the challenges they face.  

His team is now recruiting Veterans to see if a psilocybin — found in "magic mushrooms" — can help Veterans battling PTSD.  

See all of  Dr. Alan Davis' interview on the "Health Yeah!" podcast with Monica Robins:

"From a PTSD perspective, even though it's less prevalent, a lot of people don't tolerate our current treatments," Davis said.

Both research programs require a huge time commitment: An LSD treatment can last more than 12 hours, psilocybin is at least eight hours. 

"This is not just a drug people will be prescribed and take home with them," Davis stressed. "It is a a package of treatment that involves substantial screening [and] psychological and medical oversight, as well as having to have the trained professionals with people the whole duration of that process."

To learn more about the trial, click here.

While it appears some psychedelic therapies may be FDA-approved in the coming years, Davis believes treatments will likely be limited to those who are medication resistant, at first, and warns it may not be covered by insurance. 

"I think ... the jury is still out on whether or not the insurance companies or Medicaid, Medicare will pay for it," he admitted. "However, the Biden administration launched a federal task force last year to — because of the indication from the FDA that these treatments were on the horizon and because of the complexities that will be involved — there's been a task force created to start to have these conversations about whether Medicaid will cover it, whether Medicare will cover it, what will happen with the scheduling at at DEA, when and if these treatments are approved, and to coordinate some of these issues across the health and human services area.

"If that task force is successful, then we will have federalized coverage. So, if Medicaid covers it, other insurers are likely to follow suit."

As research expands, and if it continues to be promising, these mind-altering substances may be able to fix problems in just a few doses, compared to years of pills.

A cautionary tale

Like thousands of Americans, Chris Wade battled mental health disorders for most of her adult life.   

"I was diagnosed with bipolar seven years ago," she recalls.  

Over the years, she suffered multiple misdiagnoses and massive medication errors. When COVID hit and she couldn't see her psychiatrist in person, her doctor started prescribing her different doses and ultimately had her on 15 medications. 

Chris was having hallucinations and losing time. She says she'd pass out and end up some place else with no memory how she got there. 

She ended up in the ER and was told she had serotonin syndrome, and spent a week in the psychiatric ward while the medications were weened from her system. 

Wade also had treatment-esistant depression (TRD). She tried transcranial magnetic stimulation (TMS) to stimulate her nerve cells to improve the depression symptoms, to no avail. The facility that provided the TMS therapy then suggested Spravato. 

Spravato is a nasal spray approved in 2019 for TRD. The drug is esketamine, made from the drug ketamine, an anesthetic long used to treat depression. Esketamine is a more potent version.  

"I wanted to try because people with mental illness are desperate," Chris told us, "and if no medication is working, it's kind of like a last resort."

Ketamine and esketamine are legal treatments in Ohio, and both can induce profound psychedelic experiences and hallucinations. Spravato is FDA-approved, but only available through a restricted program called Risk Evaluation and Mitigation Strategy program, (REMS).  

Spravato has a boxed warning that reads, in part:

"SPRAVATO® can cause serious side effects, including:

  • Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
    • Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
    • Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
  • SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed."

Currently, Spravato is not approved for bipolar patients, and Chris says the facility knew of her bipolar diagnosis because it was in her medical records. She never should have received the drug.

"I researched the drug," she said, "but, obviously, not enough."

Wade tolerated the first two doses of Spravato, but when the dose was raised on the fourth treatment, she says she had a horrific experience.

"I had suicidal thoughts, and five minutes [later] I was thinking I was gonna have a heart attack," she remembered. "My heart rate went up to like 160, blood pressure went up. I couldn't move. I totally was frozen. I felt like I was in a cement box. The only thing that moved on my body was my eyelids. I couldn't speak, I couldn't hear. I was hallucinating."

She says she was left alone in the room. A health care professional checked on her, but Chris says she couldn't communicate anything was wrong.   

"When you remove components of protocol and you just give someone a dose of ketamine alone in a room, I think it'll be very unlikely that they would experience a therapeutic benefit or a lasting therapeutic benefit," Davis stated. "It actually increases the potential for harm."

Wade wants others to learn from her experience. While no lawyer would take on a malpractice case, she's kept a file of her experience and says she's spoken with the makers of Spravato and reported the facility to her insurance company. We're not naming the facility because no action has been taken against it, but there are several standalone mental health facilities in Northeast Ohio that now offer this treatment. 

Experts say it's important to stick with one health care provider who knows your medical history and can guide you through new options now available. When Chris received Spravato, she was not under the care of a psychiatrist.

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