Dawn Megli | (TNS) KFF Health News
Lori Tipton is one of a growing number of people who say MDMA, also known as ecstasy, saved their lives.
Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured multiple traumas that ultimately forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years, nothing helped and she began to wonder if she was “beyond repair”.
She then responded to an ad for a clinical trial of MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate and she is confident the drug could help many people. But even as regulators consider approval of the first MDMA treatment, she fears it won’t reach those who need it most.
“The main thing that always concerns me is just accessibility,” said the 43-year-old nonprofit project manager. “I don’t want this to become just another expensive complementary therapy for people who can afford it while people are dying every day at their own hands from PTSD.”
MDMA is part of a new wave of psychoactive drugs that show great potential for treating conditions such as severe depression and PTSD. Investors are rushing into this nascent field, and a host of drugs based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American herbal blend ayahuasca and the African plant ibogaine are currently in development and , in some cases, compete for government approval. Food and Drug Administration.
Supporters hope these efforts could yield the first major new treatments for mental illness since modern antidepressants were introduced in the 1980s. But not all researchers are convinced their benefits have been validated or properly weighed against risks. And they can be difficult to evaluate using traditional clinical trials.
The first MDMA-assisted therapy appeared to be on track for FDA approval in August, but a recent report from an independent review board challenged the integrity of trial data from the drug’s maker, Lykos Therapeutics , a startup founded by a researcher and psychedelic researcher. defense group. The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend approval of the drug.
Supporters of new therapies also fear that the FDA would impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for long periods of time, which would make them far too expensive for most people.
Tipton’s MDMA-assisted therapy included three eight-hour medication sessions supervised by two therapists, each followed by an overnight stay at the facility and an integration session the next day.
“It appears that some of these molecules can be administered safely,” said David Olson, director of the Davis Institute for Psychedelics and Neurotherapeutics at the University of California. “I think the question is whether they can be administered safely at the scale necessary to actually make major improvements in mental health care.” »
Revolutionary therapies?
Psychedelics and other psychoactive substances, among the oldest medications in use, have long been recognized for their potential therapeutic benefits. Modern research into these substances began in the mid-20th century, but the results of clinical trials did not live up to the claims of their advocates, and they eventually gained a bad reputation both due to their use as party drugs and rogue CIA experiments that involved unsuspecting dosing. people.
The Controlled Substances Act of 1970 made most psychoactive drugs illegal before any treatment came to market, and MDMA was classified as a Schedule 1 substance in 1985, ending all research. It wasn’t until 2000 that scientists at Johns Hopkins University received regulatory approval to study psilocybin again.
Ketamine was in a different category, having been approved as an anesthetic in 1970. In the early 2000s, researchers discovered its antidepressant effects, and a ketamine treatment, Spravato, received FDA approval in 2019. Doctors may also prescribe generic ketamine. label, and hundreds of clinics have sprung up across the country. A clinical trial is underway to evaluate the effectiveness of ketamine in treating suicidal depression when used with other psychiatric medications.
The apparent effectiveness of ketamine has sparked renewed interest in the therapeutic potential of other psychoactive substances.
They fall into distinct categories: MDMA is an entactogen, also known as an empathogen, which induces a feeling of connection and emotional communion, while LSD, psylocibin and ibogaine are psychedelics, which create altered states of perception. Ketamine is a dissociative anesthetic, although in large doses it can produce hallucinations.
Despite the differences between the drugs, Olson said they all create neuroplasticity and allow the brain to heal damaged neural circuits, which imaging shows can be shriveled in patients with addiction, depression and depression. PTSD.
“All of these brain conditions are actually disorders of neural circuits,” Olson said. “We’re basically looking for drugs that can regrow these neurons.”
Psychedelics are particularly effective in this area, he said, and show promise for treating diseases including Alzheimer’s.
A number of psychoactive drugs have now received “breakthrough therapy” designation from the FDA, speeding the development and review of drugs that could treat serious illnesses.
But standard clinical trials, in which one group of patients receives the drug and a control group receives a placebo, have proven problematic, for the simple reason that people have no difficulty determining whether they actually received the drug.
The final clinical trial of Lykos’ MDMA treatment showed that 71% of participants no longer met criteria for PTSD after 18 weeks of taking the drug, compared to 48% in the control group.
A March report from the Institute for Clinical and Economic Review, an independent research group, questioned the company’s clinical trial results and challenged the objectivity of MDMA advocates who participated in the study as patients and therapists. The institute also questioned the cost-effectiveness of the drug, which insurers consider in coverage decisions.
Lykos, a public benefit corporation, was established in 2014 as an offshoot of the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that has invested more than $150 million in research and advocacy. psychedelic rights.
The company said its researchers developed their studies in partnership with the FDA and used independent reviewers to ensure the reliability and validity of the results.
“We stand behind the design and results of our clinical trials,” a Lykos spokesperson said in an email.
There are other dangers as well. Psychoactive substances can place patients in vulnerable states, making them potential victims of financial exploitation or other types of abuse. In the second clinical trial of Lykos, two therapists spooned, cuddled, blindfolded, and pinned down a distressed female patient.
The substances can also cause shallow breathing, heart problems and hyperthermia.
To mitigate risks, the FDA may place restrictions on how drugs are administered.
“These are incredibly powerful molecules and having them available in vending machines is probably a bad idea,” said Hayim Raclaw of Negev Capital, a venture capital fund focused on developing psychedelic drugs.
But if protocols are too strict, access may be limited.
Rachel del Dosso, a trauma doctor in the greater Los Angeles area who offers ketamine-assisted therapy, said she has been following research on drugs like MDMA and psilocybin and is excited about their therapeutic potential, but had reservations about the practicalities of the treatment.
“As a therapist in clinical practice, I thought about how I could make this accessible,” she said. “Because it would cost (patients) a lot of money to have me with them through the whole process.”
Del Dosso said a group therapy model, sometimes used in ketamine therapy, could also help the adoption of other psychoactive treatments.
Artificial intelligence and the like
Researchers expect many new discoveries in this area. One of the companies Negev has invested in, Mindstate Design Labs, uses artificial intelligence to analyze “travel reports,” or self-reported drug experiences, to identify potentially therapeutic molecules. Mindstate has asked the FDA to give the green light to a clinical trial of the first molecule identified using this method, 5-MeO-MiPT, also known as moxy.
AlphaFold, an AI program developed by Google’s DeepMind, has identified thousands of potential psychedelic molecules.
Much work is also being carried out on so-called analog compounds, which have the therapeutic effects of hallucinogens but without the hallucinations. The maker of a psilocybin analog announced in March that the FDA had granted it breakthrough therapy status.
“If you can harness the neuroplasticity-promoting properties of LSD while creating an antipsychotic version of it, then that can be quite powerful,” Olson said.
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This article was produced by KFF Health News, which publishes California Healthline, an independent editorial arm of the California Health Care Foundation.
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(KFF Health News is a national newsroom that produces in-depth journalism on health issues and is one of the core operating programs of KFF – the independent source for health policy research, polling and journalism.)
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