June 5, 2024 – When Victoria Tennant, 31, woke up the day after her first psychedelic treatment, she felt as if someone had taken out her “brain, put it in a bowl of ice, and then put it back in her head.” She just felt lighter, said the Los Angeles-based neuroscience doctoral student.
She receives weekly nasal esketamine — a relative of the better-known anesthetic ketamine — for treatment-resistant depression. The FDA approved the drug — packaged and sold by Janssen Pharmaceuticals under the brand name Spravato — in spring 2019. It is the primary drug in its class of psychedelics to hit the mainstream market, paving the way in which for others, namely MDMA and psilocybin, to potentially follow in its footsteps.
Tennant has been taking antidepressants and attending therapy for six years. Although she hit a mental roadblock in her recovery, she never thought ketamine treatment was for her until she learned she was eligible for Spravato through her insurance for just $10 per session. She began her first round of treatment 6 weeks ago and has felt a big change in her day by day depression symptoms since then.
“I feel more relaxed when it comes to getting up in the morning,” she said. “Instead of it being so hard and taking so much mental energy, I can get up and get things done.”
But now that a lot of these psychedelics have gotten more widely accepted by most people, some forward-thinking organizations are looking for to get their use approved by the federal government and medical health insurance corporations. But there are still obstacles.
The Data Treatment with esketamine has been shown to enhance symptoms of depression in most patients, each within the short and long run. were less likely to relapse if the medication was taken along with the prescribed antidepressant of their alternative.
Ketamine itself shouldn’t be approved to treat depression, but it surely is usually prescribed outside of its approved indications and given intravenously. Esketamine, which is barely different from ketamine, is FDA-approved as a nasal spray for adults with treatment-resistant depression or major depressive disorder with suicidal thoughts or actions, together with an oral antidepressant.
Like ketamine, MDMA – commonly often known as ecstasy or molly – has a status as a celebration drug. It falls under the identical umbrella as psychiatric psychedelics, even though it is derived from amphetamine, a stimulant, versus ketamine, a dissociative anesthetic.
Studies on using MDMA to treat post-traumatic stress disorder (PTSD) have been ongoing for years under the leadership of Lykos Therapeutics (formerly MAPS Public Benefit Corporation).
Dr. Bronner's, the favored soap manufacturer known for its organic products, has gone to date donate 5 million dollars to Lykos to support its research and has worked with Enthea, a nonprofit startup, to have psychedelic-assisted therapy covered by their employees' medical health insurance.
In Atlanta, City Councilwoman Liliana Bakhtiari has introduced a bill that will require town's human resources department to review the professionals and cons of ketamine and psilocybin for city employees to treat mental health issues and determine whether employees' medical health insurance could cover the treatments.
Lykos Phase III clinical trialwhose results were published in September 2023, showed promising results. After 3 months of MDMA sessions and talk therapy appointments with Lykos-trained staff, 71% of patients not met PTSD criteria, in comparison with 48% within the placebo group.
But that alone wasn't enough to get the FDA to approve the therapy. The FDA's Psychopharmacologic Drugs Advisory Committee rejected the drug on Tuesday by a vote of 9 to 2 on whether it was effective and 10 to 1 on whether the advantages outweighed the risks. It advisable that the FDA not approve the therapy.
So why is the plan of action of MDMA so different from that of ketamine? Perhaps it’s on account of the basic weaknesses of Lykos' studies.
With only 104 patients, the variety of participants within the study is already smaller than in most Phase III trials. And 94 percent of those that weren’t within the placebo group and received MDMA were in a position to appropriately discover which group they belonged to. This signifies that the study was not blinded.
This was a significant concern for Dr. David Rind, general practitioner and chief medical officer of the Institute for Clinical and Economic Review, which report in March, detailing their concerns concerning the MDMA study.
“We have seen time and time again in medicine that we make mistakes when we do not conduct blinded trials,” he said. “People's opinions about the therapy they receive influence the results.”
In addition to the dearth of blinding, several allegations of misconduct got here to light – described intimately in Follow from New York MagazineThe findings come from the Cover Story podcast and were independently investigated by the institute. Some study participants reported being actively harmed over the course of the study, experiencing inappropriate behavior from therapists, or feeling pressured to report overly positive results in order not to wreck the potential way forward for MDMA in treating PTSD. However, it stays unclear how widespread these problems were.
“It's not that no one is getting benefits or that everyone is getting harmed. But it's very important how often people are getting benefits and how often people are getting harmed – and that's really hard to say right now,” Rind said.
What makes MDMA so special, say proponents and critics alike, is its ability to make people more emotionally open and socially connected. This is why it’s so much harder for doctors to prescribe MDMA therapy for PTSD and make it accessible to patients.
“MDMA produces such positive feelings of trust and connection that there have been some cases of inappropriate sexual contact between participants in [a previous] study and the individuals who support the study,” said Dr. John Krystal, chief of psychiatry at Yale-New Haven Hospital. “It's very rare, but quite extraordinary.”
It's hard to draw parallels here, says Krystal, who specializes in ketamine-assisted therapies in particular, because ketamine is a sedative that has traditionally been used in medicine as an anesthetic. So patients aren't typically stimulated in the same way with a ketamine infusion as they are with MDMA. The staffing requirements would make the cost of running MDMA treatment centers much higher than anything we've seen before in the world of psychedelic therapy, and could, in turn, make the price of entry even higher for potential patients.
But Lykos is continuing to push ahead with research into MDMA and PTSD despite the recent setback. The company is sponsoring a new study led by researchers Christy Capone (PhD) and Erica Eaton (PhD) of Brown University, focusing on MDMA-assisted therapy for PTSD and the treatment of substance use disorders in veterans.
While Capone and Eaton recognize that the high resource demands of MDMA-assisted therapy can be daunting, they have a different perspective.
“Although it might cost more resources initially, we see that after as much as two years, people feel higher and don't have to go in for treatment as often,” Eaton said. “Christy and I even have each been seeing patients usually for years and don't see any such improvement. So even though it is resource intensive initially, it may very well be more bang for our buck in the long term.”