CLEVELAND, Ohio — Mary Flynn has dealt with anxiety most of her life, having grown up in a chaotic household surrounded by alcoholism. Every medication she tried didn’t work. But she found another option — psychedelics.
Last year, the 65-year-old Cleveland resident heard about Cleveland Clinic Lutheran Hospital’s first psychedelic trial using LSD, a hallucinogen used recreationally in the 1960s, for people with generalized anxiety disorder. She was the first of three people to receive a one-time dose at Lutheran after going through an extensive examination process before being cleared to participate.
Flynn received her dose on April 19, 2023, in a dosing room at Lutheran and hasn’t been on anxiety medication since.
“Twenty minutes in, I knew that I had gotten a dose,” she said. “I was feeling euphoric. I was feeling very relaxed.”
Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic Lutheran Hospital, strongly noted that LSD will not work on everyone to manage their anxiety. Barnett ran the Clinic’s LSD study and is co-director of the hospital’s Treatment-Resistant Depression Clinic.
“We were pleasantly surprised,” he said as he stood in the dosing room where the participants stayed for 12 hours.
Flynn was on Lexapro for nine years for her anxiety and took Trazadone to help her fall asleep. Barnett gave her a schedule to ween off the medications before the study. It’s been more than a year since she’s taken those pills.
All three participants were off antidepressants at their last follow up visit at 12 weeks post dosing, said Halle Bishop, a spokesperson for the Cleveland Clinic. She does not know if the other two participants are still off their medications.
The LSD trial process
Last year, nearly 200 participants across the country received that same one-time dose of MindMed’s proprietary LSD formula as part of the randomized, controlled trial while under observation, Barnett said. Some got a 25 micrograms LSD pill, some 50 micrograms, some 100 micrograms, some 200 micrograms and some received a placebo.
MindMed delivers “therapeutic potential of psychedelics and other novel compounds” to treat mental health, the company’s website said. MindMed sponsored the Clinic and hospitals across the country for the study and is working with the U.S. Food and Drug Administration to try to get approval for its version of LSD to be used to help with anxiety.
Participants’ anxiety scores were assessed one month after the dose to assess efficacy and determine the optimal dose for future clinical trials of LSD for generalized anxiety disorder.
LSD is not FDA approved and is an experimental drug, so the Clinic needed to go through layers of approval with the FDA and Drug Enforcement Administration, Barnett said.
Psychedelic research stopped in the U.S. for decades before Johns Hopkins University, UCLA and New York University started to focus on the research in the 2000s, he said. Immediately, the universities started working on psilocybin, also known as magic mushrooms, similar to LSD. Both psychedelics have been studied in the 2010s and are believed to be effective for conditions like depression, anxiety and substance abuse disorders. This research led to the trials that are happening today, Barnett said.
The dosing room
Flynn said she immediately felt comfortable when she walked into the dosing room where she spent 12 hours being observed by a doctor. The FDA required the participants to be observed and remain in the room for that required time period.
The paintings on the wall made Flynn feel at peace. The room also includes a couch, two chairs with cushions, a rug, pillows and headphones for participants to listen to music.
“I had headphones on with curated music,” she said. “I did bring games to play in the event I got the placebo, and then I didn’t. A placebo means that for testing purposes, some people get a dose and there’s no active LSD in the dose in the capsules.”
Katelyn Schwesinger, nurse coordinator at Cleveland Clinic Lutheran, and Barnett sat with all three patients for the 12 hours they were required to be in the room. She helped support the patients while going through the trial.
“It was a very great thing to be a part of. It was really interesting for me to see these patients come in. You know I’m usually the one calling them, that’s talking to them on the phone,” she said. “When they were initially interested in the study I talked to them about their anxieties, hearing how just nothing else has been effective for their symptoms.”
Schwesinger said it was an incredible experience watching the participants feel so much better after the study.
Possible side effects during controlled LSD dosing
As with any drug, a participant could face a number of side effects, Bishop said.
“The most important ones to emphasize on dosing day are hallucinations (primarily visual and synesthesia), euphoria, illusions, increased heart rate and increased blood pressure, nausea and insomnia later that night,” she said in an email. “Anxiety, panic, challenging experiences (formerly called ‘bad trips’) and psychosis are also possible but rare.”
The Clinic warns patients of a rare potential for worsening of depression, anxiety, as well as personality challenges. Psychedelics might make someone more open to new experiences, Bishop said.
To that end, the hospital cautions participants against making life-changing decisions in the weeks after dosing such as moving, getting a divorce, switching jobs and more.
“There have not been any suicides in patients receiving psychedelics in clinical trials, but we are watching for increases in suicidal thoughts or behaviors after treatment closely since there are some case reports of suicide attempts and suicides following recreational psychedelic use,” Bishop said.
Flynn’s results with LSD, other participants’ results
When Flynn began to feel the LSD dose, she said she saw the colors of the walls and objects in the room get brighter. The paintings on the wall appeared to be dancing.
“It was a wonderful experience,” she said.
Flynn did not experience any panic during the testing time, disclosing she has taken LSD in college. She noted that you couldn’t have done LSD more than 10 times before the trial in order to participate.
“I knew what to expect and it was a very positive experience, it was very enjoyable, the music was enjoyable,” she said. “After about eight hours after the curated music, Dr. Barnett said, ‘Mary, is there anything on Spotify that you’d like to listen to?’ And I said, sure! So I listened to three Pink Floyd albums.”
Flynn said she feels great and is happy psychedelics are being looked at as an option for mental health. The drug used to be vilified in the 1960s when the “hippie-counterculture” was using LSD and protesting the Vietnam War, she said.
“The government did everything they could to make it illegal,” she said. “So, it stopped the progress of anybody using LSD or psylocibin for mental health medical uses. So it’s great that things are turned.”
Flynn called the experience “delightful” and feels lucky this changed her life, adding she’s only had positive experiences with LSD.
“(Dr. Barnett) believes that my positive attitude going in and my excitement for it helped make the outcome positive,” she said. “I’m definitely less anxious. I also retired. I worked in corporate America for (seemingly) 100 years so part of it is I take my time with things. I’m off my meds and I just don’t feel that sense of anxiety and monkeys on my back and dread. I go about my business and do everything on my time.”
Participants are showing long-term benefits from the single dose of LSD, Barnett said. The Clinic only had three participants because many were ineligible due to bipolar disorder, schizophrenia, substance abuse disorder, severe heart issues and more.
“By the time you get down that list, it’s like 90 percent of people who have whatever condition we’re looking at will not qualify for the trial,” he said. “So yeah, there’s a big chunk of people where we don’t, at least right now with the knowledge that we have, think psychedelics would be safe.”
What’s next?
The LSD trial at the Clinic has concluded and MindMed is analyzing the data and is in the process of reviewing it with the FDA, Bishop said. From there, MindMed will launch its phase 3 trial. Phase 3 will be open to more patients, but details on the design of phase 3 are incomplete because data from the trial is still being reviewed, she added.
“You need two positive phase 3 trials to get FDA approval,” Barnett said.
Barnett expects LSD to be approved as a psychiatric treatment by 2027 — with intensive training and logistics before the treatment can be rolled out.
Because of the LSD trial’s success, the Clinic expanded its psychedelic research and is currently in its psilocybin (magic mushrooms) trial to see if that drug can treat depression for those who are resistant to medication.
There are also key exclusions with this study. Some of the exclusions include prior or ongoing bipolar disorder, schizophrenia, narcissistic personality disorder, PTSD and obsessive-compulsive disorder.
Anyone interested in participating in the psilocybin trial can call the hospital at 216-425-7426 or visit the Clinc’s website and search “psilocybin”.
Kaylee Remington is the shopping and entertainment commerce reporter and metro reporter for cleveland.com and The Plain Dealer. Read her work online.
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