Psychoactive Drugs Are Having a Moment. The FDA Will Soon Weigh In.

Published

1 year ago

May 29, 2024

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Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives.

This story also ran on CBS News. It can be republished for free.

Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured layers of trauma that eventually forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years nothing helped, and she began to wonder if she was unfixable.

Then she answered an ad for a clinical trial for MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate, and she is convinced the drug could help a lot of people. But even as regulators weigh approval of the first MDMA-based treatment, shes worried that it wont reach those who need it most.

The main thing that I’m always concerned about is just accessibility, the 43-year-old nonprofit project manager said. I don’t want to see this become just another expensive add-on therapy for people who can afford it when people are dying every day by their own hand because of 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 piling into the nascent field, and a host of medications based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American plant mixture ayahuasca, and the African plant ibogaine are now under development, and in some cases vying for approval by the Food and Drug Administration.

Proponents hope the efforts could yield the first major new therapies for mental illness since the introduction of modern antidepressants in the 1980s. But not all researchers are convinced that their benefits have been validated, or properly weighed against the risks. And they can be difficult to assess using traditional clinical trials.

The first MDMA-assisted assisted therapy appeared to be on track for FDA approval this August, but a recent report from an independent review committee challenged the integrity of the trial data from the drugs maker, Lykos Therapeutics, a startup founded by a psychedelic research and advocacy group. The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend the drugs approval.

Proponents of the new therapies also worry that the FDA will impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for extended periods, that will render them far too expensive for most people.

Tiptons MDMA-assisted therapy included three eight-hour medication sessions overseen by two therapists, each followed by an overnight stay at the facility and an integration session the following day.

It does seem that some of these molecules can be administered safely, said David Olson, director of the University of California-Davis Institute for Psychedelics and Neurotherapeutics. I think the question is can they be administered safely at the scale needed to really make major improvements in mental health care. Email Sign-Up

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Breakthrough Therapies?

Psychedelics and other psychoactive substances, among the medicines with the oldest recorded use, have long been recognized for their potential therapeutic benefits. Modern research on them started in the mid-20th century, but clinical trial results didnt live up to the claims of advocates, and they eventually got a bad name both from their use as party drugs and from rogue CIA experiments that involved dosing unsuspecting individuals.

The 1970 Controlled Substances Act made most psychoactive drugs illegal before any treatments were brought to market, and MDMA was classified as a Schedule 1 substance in 1985, which effectively ended any research. It wasnt until 2000 that scientists at Johns Hopkins University were granted regulatory approval to study psilocybin anew.

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-based therapy, Spravato, received FDA approval in 2019. Doctors can also prescribe generic ketamine off-label, and hundreds of clinics have sprung up across the nation. A clinical trial is underway to evaluate ketamines effectiveness in treating suicidal depression when used with other psychiatric medications.

Ketamines apparent effectiveness 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 sense of connectedness and emotional communion, while LSD, psylocibin, and ibogaine are psychedelics, which create altered perceptual states. Ketamine is a dissociative anesthetic, though it can produce hallucinations at the right dose.

Despite the drugs differences, Olson said they all create neuroplasticity and allow the brain to heal damaged neural circuits, which imaging shows can be shriveled up in patients with addiction, depression, and PTSD.

All of these brain conditions are really disorders of neural circuits, Olson said. We’re basically looking for medicines that can regrow these neurons.

Psychedelics are particularly good at doing this, he said, and hold promise for treating diseases including Alzheimers.

A number of psychoactive drugs have now received the FDAs breakthrough therapy designation, which expedites development and review of drugs with the potential to treat serious conditions.

But standard clinical trials, in which one group of patients is given the drug and a control group is given a placebo, have proven problematic, for the simple reason that people have no trouble determining whether theyve gotten the real thing.

The final clinical trial for Lykos MDMA treatment showed that 71% of participants no longer met the criteria for PTSD after 18 weeks of taking the drug versus 48% in the control group.

A March report by the Institute for Clinical and Economic Review, an independent research group, questioned the companys clinical trial results and challenged the objectivity of MDMA advocates who participated in the study as both patients and therapists. The institute also questioned the drugs cost-effectiveness, which insurers factor into coverage decisions.

Lykos, a public benefit company, was formed in 2014 as an offshoot of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that has invested more than $150 million into psychedelic research and advocacy.

The company said its researchers developed their studies in partnership with the FDA and used independent raters 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 hazards too. Psychoactive substances can put patients in vulnerable states, making them potential victims for financial exploitation or other types of abuse. In Lykos second clinical trial, two therapists were found to have spooned, cuddled, blindfolded, and pinned down a female patient who was in distress.

The substances can also cause shallow breathing, heart issues, and hyperthermia.

To mitigate risks, the FDA can put restrictions on how drugs are administered.

These are incredibly potent 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 psychedelic drug development.

But if the protocols are too stringent, access is likely to be limited.

Rachel del Dosso, a trauma therapist in the greater Los Angeles area who offers ketamine-assisted therapy, said shes been following the research on drugs like MDMA and psilocybin and is excited for their therapeutic potential but has reservations about the practicalities of treatment.

As a therapist in clinical practice, I’ve been thinking through how could I make that accessible, he said. Because it would cost a lot for [patients] to have me with them for the whole thing.

Del Dosso said a group therapy model, which is sometimes used in ketamine therapy, could help scale the adoption of other psychoactive treatments, too.

Artificial Intelligence and Analogs

Researchers expect plenty of new discoveries in the field. One of the companies Negev has invested in, Mindstate Design Labs, uses artificial intelligence to analyze trip reports, or self-reported drug experiences, to identify potentially therapeutic molecules. Mindstate has asked the FDA to green-light a clinical trial of the first molecule identified through this method, 5-MeO-MiPT, also known as moxy.

AlphaFold, an AI program developed by Googles DeepMind, has identified thousands of potential psychedelic molecules.

Theres also a lot of work going into 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 also creating an antipsychotic version of it, then that can be pretty powerful, Olson said.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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Politics

UK played ‘vital role’ in Gaza peace deal, says Trump aide, after minister branded ‘delusional’

Published

50 mins ago

October 13, 2025

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UK played 'vital role' in Gaza peace deal, says Trump aide, after minister branded 'delusional'

Steve Witkoff, the US special envoy to the Middle East, has claimed the UK played a “vital role” in helping negotiate the Gaza peace deal, smoothing over a potential diplomatic row between London and Washington.

Witkoff took to X on Monday, ahead of meeting President Donald Trump in Israel, to praise the UK.

“I would like to acknowledge the vital role of the United Kingdom in assisting and coordinating efforts that have led us to this historic day in Israel,” Witkoff wrote.

“In particular, I want to recognise the incredible input and tireless efforts of National Security Advisor Jonathan Powell.”

His comments came 24 hours after education secretary Bridget Phillipson was branded “delusional” by Mike Huckabee, the US ambassador to Israel, for claiming that Sir Keir Starmer’s presence at a signing ceremony for today’s ceasefire deal in Egypt “demonstrates the key role that we [Britain] have played”.

The minister made her remarks on Sunday Morning With Trevor Phillips but did not say exactly what the UK’s role in the ceasefire, largely attributed to Donald Trump, is or was.

Politics latest: Phillipson announces crackdown on antisemitism at UK universities

Phillipson added: “We have played a key role behind the scenes in shaping this.

“It’s right that we do so because it’s in all of our interest, including our own national interest, that we move to a lasting peace in the region.

“These are complex matters of diplomacy that we are involved in. But we do welcome and recognise the critical role that the American government played in moving us to this point.”

Her comments prompted Mr Huckabee to repost the Sky News clip on social media, claiming: “I assure you she’s delusional.”

He added: “She can thank Donald Trump anytime just to set the record straight.”

Mr Huckabee was part of the negotiating team for the peace deal, with Mr Trump calling the former Arkansas governor “AMAZING” as he said he “worked so hard, and did so much, to bring about peace in the Middle East”.

In August, Mr Huckabee said the UK and other European nations that said they would declare a Palestinian state were “having the counterproductive effect that they probably think that they want”.

Israel: UK did not play key role in peace deal

Israel’s deputy foreign affairs minister, Sharren Haskell backed Huckabee, telling Sky News the UK played “the opposite” of a key role in the peace deal after recognising the Palestinian state.

“The message that the UK government has sent Hamas was the message that: the longer they continue this war, they will be rewarded.

“I mean, you must understand that when a terrorist organisation is thanking you. You are on the wrong side of history.”

It is understood the prime minister has underlined Mr Trump’s key role in securing this deal throughout the process. Publicly, he praised Mr Trump twice in his press conference in India on Thursday.

Ms Phillipson stood by the September decision to declare a Palestinian state, saying it was “the right thing to do”.

Husam Zomlot, the Palestinian ambassador to the UK, told Sky News it was a “moment of leadership” for the UK to declare a Palestinian state, and a “responsibility to begin to correct a century of the gravest historic injustices committed against our people”.

He added: “That moment three weeks ago, when the UK did recognise, is a moment when we can say that the wheels of history are turning in a different direction.”

No plans for British troops on the ground

The education secretary also told Sky News the government has “no plans” to put British troops into Israel or Gaza as part of a stabilisation force after the ceasefire.

The US military will help establish a multinational force in Israel, known as a civil-military coordination centre, which is likely to include troops from Egypt, Qatar, Turkey and the UAE.

On Friday, US officials said up to 200 US troops already based in the Middle East will be moved to Israel to help monitor the ceasefire in Gaza.

The day before, President Trump announced Israel and Hamas had “signed off on the first phase” of a peace plan he unveiled last week.

Aid trucks have been gathering in Egypt to cross into Gaza after months of warnings by aid groups of famine in parts of the territory.

In Israel, the remaining hostages are due to be returned from Gaza by Hamas on Monday under the first phase of the peace plan. Twenty are believed to still be alive, 26 have been declared dead, while the fate of two is unknown.

The ceasefire agreement has been made two years after Hamas stormed Israel on 7 October 2023, killing 1,200 people and taking 251 hostages.

Israel’s military offensive has killed more than 67,000 Palestinians in Gaza, according to the Hamas-run health ministry, which the UN deems reliable.

World

Chants of frustration turn into songs of celebration in Tel Aviv as crowds greet hostages

Published

50 mins ago

October 13, 2025

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Chants of frustration turn into songs of celebration in Tel Aviv as crowds greet hostages

For two years, they have gathered in Hostages Square – parents, brothers, sisters, extended family and friends clutching photographs and signs reading “bring them home”.

They have campaigned, protested and prayed for the return of loved ones taken in the 7 October attacks.

But now the mood has shifted.

The chants of frustration have turned into songs of celebration.

The tears that once fell in despair are now tears of relief.

The square, normally a site of weekly demonstrations, has transformed into a sea of flags.

Gaza: Follow the latest updates

We watched as tens of thousands packed into this area of Tel Aviv to witness a moment many feared might never come – the homecoming of the remaining hostages.

Every few minutes, the massive video screens behind the stage beamed new images – exhausted but smiling hostages embracing their families.

Each clip is met with a roar of applause – the atmosphere is one of sheer elation, it is electric.

When helicopters pass overhead, ferrying freed captives to nearby hospitals, the crowd erupts again and again, looking upwards to the sky in awe at the impossible that’s now been made possible.

The sense of catharsis here is palpable – at last some closure after a nightmare two years and a chance for the healing process of a nation to begin.

But beneath the jubilation, there’s a deep well of sorrow – and reckoning.

The 7 October massacre was the deadliest single-day attack on Israel since the nation’s founding in 1948 – an event that upended the country’s sense of safety and unity.

More than 1,000 were killed that day, and hundreds were taken into Gaza.

For the families who never stopped fighting for their return, this is both an ending and a beginning.

Now that the living hostages are home, attention turns to those who did not survive.

Officials say the process of identifying and repatriating remains will take time – and for some families, closure still remains heartbreakingly out of reach.

But the questions that linger extend far beyond grief.

In the days and weeks ahead, the Israeli government faces intense scrutiny.

How could the country’s fabled intelligence and defence apparatus fail so catastrophically?

And what accountability, if any, will fall on Prime Minister Benjamin Netanyahu, who has faced mounting criticism over both the failures leading up to the attack and the protracted efforts to secure the hostages’ release?

This is a nation rejoicing, but also searching for answers.

For now, though, the families in this square are holding tight to one immutable positive – after more than two long years, the living hostages, at least, are finally home.

World

Drones capture staggering images of Gaza devastation – as people find nothing left

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50 mins ago

October 13, 2025

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Drones capture staggering images of Gaza devastation - as people find nothing left

Drones have been a common sight in Gaza for a long time, but they have always been military.

The whine of a drone is enough to trigger fear in many within the enclave.

But now, drones are delivering something different – long, lingering footage of the devastation that has been wreaked on Gaza. And the images are quite staggering.

Gaza latest: Chants of ‘thank you Trump’ in Hostages Square

Whole city blocks reduced to rubble. Streets destroyed. Towns where the landscape has been wholly redesigned.

Decapitated tower blocks and whole areas turned into black and white photographs, where there is no colour but only a palette of greys – from the dark hues of scorched walls to the lightest grey of the dust that floats through the air.

And everywhere, the indistinct dull grey of rubble – the debris of things that are no longer there.

The joy that met the ceasefire has now changed into degrees of anxiety and shock.

Gaza is full of people who are returning to their homes and hoping for good news. For a lucky few, fortune is kind, but for most, the news is bad.

Umm Firas has been displaced from her home in Khan Younis for the past five months. She returned today to the district she knew so well. And what she found was nothing.

“This morning we returned to our land, to see our homes, the neighbourhoods where we once lived,” she says.

“But we found no trace of any houses, no streets, no neighbourhoods, no trees. Even the crops, even the trees – all of them had been bulldozed. The entire area has been destroyed.

“There used to be more than 1,750 houses in the block where we lived, but now not a single one remains standing. Every neighbourhood is destroyed, every home is destroyed, every school is destroyed, every tree is destroyed. The area is unliveable.

“There’s no infrastructure, no place where we can even set up a tent to sit in. Our area, in downtown Khan Younis used to be densely populated. Our homes were built right next to each other. Now there is literally nowhere to go.

“Where can we go? We can’t even find an empty spot to pitch our tent over the ruins of our own homes. So we are going to have to stay homeless and displaced.”

It is a story that comes up again and again. One man says that he cannot even reach his house because it is still too near the Israeli military officers stationed in the area.

Another, an older man whose bright pink glasses obscure weary eyes, says there is “nothing left” of his home “so we are leaving it to God”.

“I’m glad we survived and are in good health,” he says, “and now we can return there even if it means we need to eat sand!”

The bulldozers have already started work across the strip, trying to clear roads and allow access. Debris is being piled into huge piles, but this is a tiny sticking plaster on a huge wound.

The more you see of Gaza, the more impossible the task seems of rebuilding this place. The devastation is so utterly overwhelming.

Bodies are being found in the rubble while towns are full of buildings that have been so badly damaged they will have to be pulled down.

Humanitarian aid is needed urgently, but, for the moment, the entry points remain closed. Charities are pleading for access.

It is, of course, better for people to live without war than with it. Peace in Gaza gifts the ability to sleep a little better and worry a little less. But when people do wake up, what they see is an apocalyptic landscape of catastrophic destruction.