Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD

MATTHEW PERRONE 

AP health writer

May 31, 2024, 

WASHINGTON -- Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decadeslong effort by advocates to move psychedelic drugs into the medical mainstream.

The Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA — currently illegal under federal law — becomes the first drug of its kind to win U.S. approval as a medication. The experts will discuss the quality of the evidence and safety concerns Tuesday, including MDMA's potential for abuse, before taking a nonbinding vote on the drug's overall benefits and risks. The FDA will make the final decision, likely in August.

In their assessment, FDA scientists said that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms,." But they also called the research “challenging to interpret,” and questioned how long the benefits might last. They said it’s difficult to know how much of the improvement came from MDMA versus simply undergoing intensive therapy, and also raised several safety concerns, including MDMA's potential to cause heart problems.

Post-traumatic stress disorder is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans. Currently antidepressants are the only FDA-approved drugs for the condition.

If approved, MDMA would be reclassified as a prescription medicine and made available to specially certified doctors and therapists. Currently the drug is in the same ultra-restrictive category as heroin and other substances the federal government deems prone to abuse and devoid of any medical use.

MDMA, also known as ecstasy or molly, is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years. It’s part of a resurgence of research into the potential of psychedelics for hard-to-treat conditions like depression, addiction and anxiety. MDMA's main effect is triggering feelings of intimacy, connection and euphoria.

Companies are studying MDMA, psilocybin, LSD and other mind-expanding drugs for numerous mental health problems.

Until recently, psychedelic research was mainly funded by a handful of nonprofit advocacy groups, including Multidisciplinary Association for Psychedelic Studies, or MAPS. The company seeking approval for MDMA, Lykos Therapeutics, is essentially a corporate spinoff of MAPS, which conducted all the studies submitted for FDA review.

In two MAPS studies, patients received MDMA as part of an intensive, four-month course of talk therapy lasting more than a dozen sessions, only three of which involved taking the drug. The drug is thought to help patients come to terms with their trauma and let go of disturbing thoughts and memories.

The group studied its approach in 195 adults with moderate-to-severe PTSD who were randomly assigned to undergo the therapy with MDMA or with a dummy pill. Following treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to be in remission.

But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the so-called “blinded” objectivity considered essential for high-quality drug research. The agency also questioned how long the drug's benefits might last. MAPS tracked some patients for up to two years, but reviewers noted that about a quarter of patients quickly dropped out of the follow-up study, limiting the usefulness of the results.

The most common side effects of MDMA included headache, nausea, muscle tightness and decreased appetite. More serious issues included heart palpitations and elevated blood pressure, which FDA reviewers said had the “potential to trigger” life-threatening heart problems.

They also raised concerns about the potential for patients to abuse MDMA, which functions similarly to amphetamines and other stimulants.

While MDMA would be a first-of-a-kind approval, U.S. doctors and the FDA itself have already laid some of the groundwork for working with drugs that can cause intense, psychological experiences.

Hundreds of clinics across the U.S. already offer ketamine — the powerful anesthetic sometimes used as a party drug — to treat a host of ailments, including depression, anxiety, chronic pain and PTSD. The FDA has only formally approved the drug for use during surgery, but its availability allows doctors to prescribe it “off-label” for various mental and physical ailments.

In 2019, the FDA approved Johnson & Johnson’s proprietary form of the drug, Spravato, a nasal spray that treats severe depression. Similar to ketamine, the drug is offered at doctor’s offices and clinics where patients usually spend several hours reclining in a chair.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

LA REVUE GAUCHE - Left Comment: Search results for Psychedelic 

LA REVUE GAUCHE - Left Comment: Search results for MDMA 

Psychedelic-assisted therapies for patients with PTSD

The resurgence of research into psychedelic-based treatments is poised to benefit many people who face mental health challenges, such as post-traumatic stress disorder, but how do they feel about it?

Peer-Reviewed Publication

MEDICAL UNIVERSITY OF SOUTH CAROLINA

 

IMAGE: MEDICAL UNIVERSITY OF SOUTH CAROLINA PSYCHIATRIST DR. JENNIFER JONES (LEFT) AND MELISSA MICHEL (RIGHT, RECLINING), LEAD THERAPIST FOR MUSC'S CENTERSPACE CLINIC, DEMONSTRATING PSYCHEDELIC-ASSISTED THERAPY. view more 

CREDIT: MEDICAL UNIVERSITY OF SOUTH CAROLINA. PHOTOGRAPH COURTESY OF DR. JENNIFER JONES.

Psychedelic-based therapies are poised to change the treatments that psychiatrists can offer patients.

“I often talk about psychedelic treatments as catalysts for change, for both the individual and the field of psychiatry,” said Medical University of South Carolina psychiatrist Jennifer Jones, M.D., who conducts research on these treatments.

The highly anticipated approval of MDMA, or “ecstasy,” to treat post-traumatic stress disorder would be the first for a psychedelic drug, ushering in changes for patients, mental health providers and society. The Food and Drug Administration is expected to issue a decision on MDMA-assisted therapy for PTSD in early 2024.

How well this revolutionary research will be implemented into practice will depend on patients’ willingness to undergo psychedelic-based treatments and their ability to access those treatments, said Jones. Jones’ latest research, published in Frontiers in Psychiatry, examines these potential barriers in a population that stands to benefit greatly from psychedelic therapies for PTSD: individuals that use substances.

Changing treatments and outcomes

Approval of psychedelic therapies could help patients with mental illnesses, particularly those with multiple or treatment-resistant disorders. PTSD is an often severe mental disorder that can occur after being exposed to a traumatic event. Current treatments, while improving symptoms in some patients, leave many without any benefit at all.

For the many people who have PTSD and habitually use alcohol or other substances, rates of nonresponse to treatment are even higher. Jones thinks this is unacceptable, so she started researching new approaches to treat patients with both PTSD and a substance use disorder.

A promising ‘new’ treatment option for patients with both PTSD and SUD may come from an ‘old’ group of drugs called psychedelics. Psychedelics include both natural (psilocybin, mescaline, DMT) and synthetic (LSD, MDMA) drugs. Natural psychedelics have been used medicinally and spiritually in traditional cultures for centuries. However, they were described scientifically mostly in the 1950s and 1960s.

“It is really interesting – in these early studies looking at psychedelic therapy for one indication, like PTSD, they noticed improvements in symptoms of another mental health disorder, like depression or SUD,” said Jones.

Since 2009, approximately 80 clinical trials involving MDMA have been completed or are ongoing, according to Clinicaltrials.gov. These trials investigate the use of MDMA in a wide range of disorders, including anxiety, depression, obsessive compulsive disorder, SUD and PTSD. These diverse studies highlight the potential effects of MDMA across multiple disorders, something that prior treatments have lacked.

“This is really important,” said Jones. “It is very common to have concurrent mental health disorders, so having a treatment like MDMA that could, for example, improve both PTSD and SUD symptoms is really exciting for the field.”

Currently, drugs used to treat PTSD may be given with or without another form of therapy, broadly referred to as “talk therapy.” For MDMA-assisted therapy, the talk therapy component is a fundamental part of the treatment.

“In the context of MDMA-assisted therapy for PTSD, MDMA is thought to dampen the fear response around the traumatic memory, allowing the participant to engage with the therapy team to process this memory, sometimes for the first time in their lives,” said Jones. “Instead of running from it, they can process the traumatic memory and move past it.”

This processing may also apply to other mental functions, perhaps accounting for MDMA’s ability to improve symptoms for other disorders, like SUD.

“Participants in psychedelic clinical trials have lasting benefits that come from changes in their behaviors, their thought processes and their interactions with others,” said Jones. “Participants often point to these changes as what made the difference in their symptoms.”

The immediate effects of MDMA during therapy are not without concern, however. Jones is often asked whether the MDMA will produce feelings of “ecstasy.” “Ecstasy is a common descriptor for the effects caused by recreational MDMA, used so frequently that it became a nickname for the drug. However, because this therapy is a difficult process of self-healing, MDMA in this context does not usually produce ecstasy, Jones said. This common concern points to some of the possible barriers that Jones wanted to assess in her recent publication.

Changing minds

For some, reluctance to receive MDMA-assisted therapy is tied to negative views of psychedelics and their recreational uses. In the 1970s, all psychedelics were classified as Schedule I substances, drugs with high-abuse potential without clinical benefits, tarnishing political and public perceptions of these drugs. Their recreational use and representations in media have continued to perpetuate this stigma.

Negative views of psychedelics and increasing regulatory control halted early promising research on psychedelics in Western medicine in the 1970s, reported the Multidisciplinary Association for Psychedelic Studies. It wasn’t until the 1990s that officially sanctioned psychedelic research resumed on a small scale, only accelerating in the 2010s. New government policies allowed psychedelic clinical research to resume, but public perceptions of psychedelics will determine the success of these drugs as treatments.

In Jones’ study, approximately 70% of survey respondents indicated their support for MDMA-based research and belief that MDMA could be useful for treating mental health disorders. A smaller group, 59%, would be willing to receive an MDMA-based treatment if it were recommended by a mental health provider. The survey results suggest that most people who use substances are open to MDMA research and would be willing to try an MDMA-based therapy.

Jones also examined the role of race and ethnicity on opinions about MDMA-assisted therapy. Despite their underrepresentation in psychedelic clinical trials, racial and ethnic groups had similar levels of support for MDMA research. However, there were small, but potentially important, differences in willingness to try an MDMA-based therapy. “While largely a hypothesis,” said Jones, “differences in willingness to participate in clinical trials are probably related to prior use or cultural beliefs.”

While this research brings up additional questions for Jones and colleagues, she believes these results can help researchers and mental health providers to understand how to develop and implement treatments more equitably for different patient and ethnic populations.

By discussing these issues prior to the FDA decision, Jones hopes steps can be taken to address patient concerns.

“It is my heartfelt goal that everyone who might benefit from MDMA-assisted therapy is able to receive treatment once it is available, and that they will not be held back by worries or stigma about the treatment,” said Jones. “For that to be a reality, we have to seek input directly from those most likely to benefit from the treatments that we are developing.”

 

# # #

About MUSC

Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $298 million in research funds in fiscal year 2022, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding, with more than $220 million. For information on academic programs, visit musc.edu.

As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned and equity stake), with approximately 2,700 beds and four additional hospital locations in development; more than 350 telehealth sites and connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2022, for the eighth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

MUSC has a total enterprise annual operating budget of $5.1 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient

---

JOURNAL

Frontiers in Psychiatry

DOI

10.3389/fpsyt.2023.1096298 

METHOD OF RESEARCH

Survey

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Perspectives on the therapeutic potential of MDMA: A nation-wide exploratory survey among substance users.

MDMA 'outperforms' expectations in trial as medicine for PTSD

BETTER LIVING THROUGH CHEMISTRY

Rob Waugh
·Contributor
Mon, 29 January 2024 

MDMA could soon be used as a medicine, researchers say (Getty)

MDMA is better known as the dancefloor hallucinogen Ecstasy, but it may have important uses as a medicine, a new study has shown.

The research found that - when paired with therapy - MDMA significantly outperformed therapy alone when it came to dealing with PTSD (post-traumatic stress disorder).

The difference was particularly stark when it came to people dealing with traumas from early childhood, which are especially hard to deal with through therapy.


The researchers said: "MDMA may be particularly effective for enhancing treatment efficacy by improving a range of problems with self-experience that are associated with treatment resistance."

In particular, the drug may be able to help patients who have been traumatised during childhood confront their issues and deal with problems such as alexithymia - an inability to recognise emotions.

The study found people who took MDMA responded better to therapy. (Getty)

The researchers added: "Even though the MDMA-assisted therapy experimental sessions often occurred in relative silence as participants focus largely on their inner experience, MDMA-assisted therapy was associated with a significant improvement in emotional self-awareness and loss of alexithymia.

"This suggests that MDMA-assisted therapy can facilitate accessing painful memories and experiences that under ordinary conditions are too overwhelming and terrifying to confront, even in the presence of trained therapists."
Recommended reading

Scientists may have found how LSD treats mental illness (Daily Beast)


LSD might be good for us (Esquire)


Here's what LSD does inside your brain (Yahoo News)

How did the study work?

Speaking to Vox, researcher Bessel Van derk Kolk, author of The Body Keeps the Score, Brain Mind and Body in the Healing of Trauma, said he was initially reluctant to include people with childhood trauma in the study.

In the end, the study, which aims to legitimise the use of MDMA-assisted therapy, included 84% people with early childhood trauma.

The subjects were split into two groups, one of which had therapy, and one which had 36 hours of MDMA-assisted therapy.

Van der Kolk said: "We had the best outcome data here with MDMA that I’ve ever seen for any study."
Can psychedelic drugs really treat illnesses?

Research has shown that certain psychedelic drugs such as psilocybin (the ingredient in magic mushrooms) and MDMA can have an impact on problems such as depression and post-traumatic stress disorder.

On LSD, the picture is less clear.

A small trial in 2018, funded by the Beckley Foundation and led by the 'first lady of LSD', Amanda Feilding, the Countess of Wemyss and March, saw 20 volunteers take the drug and fill in psychological questionnaires.

Feilding said: "I took it in the 1960s when it was legal and it improved my wellbeing."

A systematic review of studies into LSD in Frontiers in Psychiatry in 2020 found that the drug was a "potential therapeutic agent", with the strongest evidence around using LSD to treat alcoholism.
Will MDMA really be legal a medicine?

In 2017, the US Food and Drug Administration awarded the drug 'breakthrough status', so it could be fast-tracked as a potential treatment.

MDMA is often illegally sold on the street. (Getty)

Studies have shown that patients with PTSD – where it's difficult to deal with painful memories – can overcome their traumas, long-term, with the aid of MDMA.

Several successful trials have shown the drug's potential with PTSD, and some believe approval could come this year.

Australia Becomes First Country to Legalize Therapeutic Use of MDMA and Psilocybin

One expert called the move a "very welcome step away from what has been decades of demonization."


Trisha Suppes, founder of the Bipolar and Depression Research Program at the Palo Alto VA Medical Center in California, points during a November 4, 2022 presentation to what she called "stunning" results showing a reduction in treatment-resistant depression among patients undergoing psilocybin therapy.
(Photo: Steve Jurvetson/flickr/cc)

BRETT WILKINS
Feb 03, 2023

After decades of criminalization, Australia's government said Friday that it will legalize the prescription of MDMA and psilocybin for the treatment of two medical conditions, a historic move hailed by researchers who have studied the therapeutic possibilities of the drugs.

Australia's Therapeutic Goods Administration (TGA) said in a statement that starting July 1, psychiatrists may prescribe MDMA (3,4-methylenedioxy-methamphetamine), commonly called "Molly" or "ecstasy" by recreational users, to treat post-traumatic stress disorder (PTSD) and psilocybin—the psychedelic prodrug compound in "magic" mushrooms—for treatment-resistant depression.

"These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients," TGA said, adding that the drugs must be taken "in a controlled medical setting."

Advocates of MDMA and psilocybin are hopeful that one day doctors could prescribe them to treat a range of conditions, from alcoholism and eating disorders to obsessive-compulsive disorder.

David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University, toldThe Guardian that Friday's surprise announcement is a "very welcome step away from what has been decades of demonization."

Caldicott said it is now "abundantly clear” that both MDMA and psilocybin "can have dramatic effects" on hard-to-treat mental health problems, and that "in addition to a clear and evolving therapeutic benefit, [legalization] also offers the chance to catch up on the decades of lost opportunity [of] delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological 'war on drugs.'"

MDMA—which has been criminalized in Australia since 1987—was first patented by German drugmaker Merck in the early 1910s. After World War II the United States military explored possibilities for weaponizing MDMA as a truth serum as part of the MK-ULTRA mind control experiments aimed at creating real-life Manchurian candidates. A crossover from clinical usage in marriage and other therapies in the 1970s and '80s to recreational consumption—especially in the disco and burgeoning rave scenes—in the latter decade sparked a conservative backlash in the form of emergency bans in countries including Australia, the United Kingdom, and the United States. The U.S. Drug Enforcement Administration classifies MDMA and psilocybin as Schedule I substances, meaning they have "no currently accepted medical use and a high potential for abuse."

Patients who've tried MDMA therapy and those who treat them say otherwise. A study published last year by John Hopkins Health found that in a carefully controlled setting, psilocybin-assisted psychotherapy held promise for "significant and durable improvements in depression."

The California-based Multidisciplinary Association for Psychedelic Studies (MAPS)—the world's premier organization for psychedelic advocacy and research—interviewed Colorado massage therapist Rachael Kaplan about her MDMA-assisted therapy for PTSD:

For the majority of my life I prayed to die and fought suicidal urges as I struggled with complex PTSD. This PTSD was born out of chronic severe childhood abuse. Since then, my life has been a journey of searching for healing. I started going to therapy 21 years ago, and since then I have tried every healing modality that I could think of, such as bodywork, energy work, medications, residential treatment, and more. Many of these modalities were beneficial but none of them significantly reduced my trauma symptoms. I was still terrified most of the time...

In my first MDMA-assisted psychotherapy session I was surprised that the MDMA helped me see the world as it was, instead of seeing it through my lens of terror. I thought that the MDMA would alter my perception of reality, but instead, it helped me see... more clearly... The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything... There are no words for the gratitude that I feel.

Jon Lubecky, an American Iraq War combat veteran who tried to kill himself five times, toldNBC's "Today" in 2021 that MDMA therapy—also with MAPS—enabled him "to talk about things I had never brought up before to anyone."

"And it was OK. My body did not betray me. I didn't get panic attacks. I didn't shut down emotionally or just become so overemotional I couldn't deal with anything," he recounted.

"This treatment is the reason my son has a father instead of a folded flag," Lubecky said in a message to other veterans afflicted with PTSD. "I want all of you to be around in 2023 when this is [U.S. Food and Drug Administration]-approved. I know what your suffering is like. You can make it."

MAPS' latest clinical research on MDMA—which is aimed at winning FDA approval—is currently in phase three trials. The Biden administration said last year that it "anticipates" MDMA and psilocybin would be approved by the FDA by 2024 and is "exploring the prospect of establishing a federal task force to monitor" therapeutic possibilities of both drugs.

Like MDMA, psilocybin—which occurs naturally in hundreds of fungal species and has been used by humans for medicinal, spiritual, and recreational purposes for millennia—remains illegal at the federal level in the U.S., although several states and municipalities have legalized or decriminalized psychedelic mushrooms, or have moved to do so.

There have also been bipartisan congressional efforts to allow patients access to both drugs. Legislation introduced last year by U.S. Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) would permit therapeutic use of certain Schedule I drugs for terminally ill patients. Meanwhile, Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Dan Crenshaw (R-Texas) passed amendments to the 2023 National Defense Authorization Act providing more funding for psychedelic research and making it easier for veterans and active-duty troops suffering from PTSD to try drug-based treatments.

MDMA and Psilocybin Are Approved as Medicines for the First Time

Many are celebrating Australia’s decision to pave the way for these psychedelic therapies, but questions around accessibility remain.


GRACE BROWNE

WIRED.COM

03.02.2023 

In a world-first, Australia has announced it will officially recognize MDMA and psilocybin as medicines.

On February 3, Australia’s Therapeutic Goods Administration (TGA)—the government authority responsible for regulating medicines—announced that starting July 1, 2023, authorized psychiatrists will be able to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD), and psilocybin, the active ingredient in magic mushrooms, for ​​treatment-resistant depression. Because the TGA has yet to approve any actual medicines that contain MDMA or psilocybin, patients will initially be receiving “unapproved” medicines containing the substances.

The decision came as a big surprise. At the end of December 2021, the same regulatory body decided against down-scheduling the drugs for use in a medical context. “When I woke up, my email was completely flooded with people saying: ‘Have you heard what’s happened?’ I was shocked by the decision,” says Simon Ruffell, a psychiatrist and senior research fellow at the Psychae Institute at the University of Melbourne.

Before advocates celebrate, experts warn that there are still many questions around just how many people will be actually able to access these treatments come July 1, as well as whether Australia has jumped the gun before gathering enough evidence on how to roll out these treatments effectively and safely.

“I think it will take a while to ramp up,” says Daniel Perkins, adjunct associate professor at the Centre for Mental Health at Swinburne University and a senior research fellow at the University of Melbourne. This is wise, he says: Let it gradually open up to see what works well and what does not. “They’ve probably intentionally done it this way.”

The path for a psychiatrist to get the all-clear to dole out the drugs could be lengthy and twisted. First, psychiatrists will need to be approved under Australia’s Authorised Prescriber Scheme, which means being endorsed by a human research ethics committee and then the TGA. For this, they’ll need to prove that they can clinically justify the treatment regime, that they will have proper governance over the treatment process, and that they will be using suitable measures to protect patients. What exactly these measures look like in practice have yet to be laid out in detail by the TGA.

Plus, the TGA has yet to provide any detail regarding the minimum training standards required for psychiatrists to become authorized prescribers. This makes exactly how these treatments will be prescribed ambiguous, considering the bedrock of evidence to support them involves patients receiving therapy from trained professionals alongside the drugs themselves. Because of this—and because the TGA has put the onus on the psychiatrist to demonstrate that their prescribing practices are appropriate—providing therapy in conjunction with the drugs will likely be required, says Rhys Cohen, who is on the non-executive advisory board of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney and consults for the medical cannabis industry.

And not just any psychiatrist or psychologist can safely administer these kinds of therapies. Ruffell points out that in well-established Indigenous psychedelic practices around the world, people spend five to 10 years, at least, training to be able to work with these kinds of substances. “I think that a grave error would be to think that psychiatric and psychological qualifications are transferable to psychedelic substances without additional training.”

Another barrier to access will likely be cost. The treatments won’t be covered by health insurance, “so it’s probably initially going to be a therapy for relatively well-off people who have these conditions,” Perkins says.

Some worry that Australia may be putting the cart before the horse in terms of the safety and long-term effects of these treatments. “We haven’t even looked at any longer term data yet,” says Ruffell. “The longest data that we have is 12 months. We don’t really know what happens later down the line.”

But on the other hand, “the benefit, particularly for the treatment-resistant conditions that they’re talking about—PTSD and depression—could be really huge,” says Perkins.

Mostly, there’s a sense of surprise that Australia is first off the mark. At the beginning of 2023, Oregon became the first US state to allow adult use of psilocybin “under the supervision of a state-certified facilitator,” though the substance remains an unapproved investigational drug in the US for now. It’s been predicted that the US Food and Drug Administration will approve MDMA for the treatment of PTSD in 2024. Switzerland allows a limited number of psychiatrists to use LSD and MDMA to assist psychotherapy. How the scheme unfolds in Australia will likely impact whether other countries choose to offer the drugs for therapeutic purposes in the future—and that includes if it goes wrong and people get harmed. “I think the eyes of the world will be watching Australia now,” Ruffell says.

For Ruffell, the optimist in him is excited that psychedelic medicine is finally getting somewhere. “And then the pessimist is like, could this have a negative outcome?” he says. “I hope not. But that will be determined in the future.”

LA REVUE GAUCHE - Left Comment: Search results for PSYCHEDELIC 

LA REVUE GAUCHE - Left Comment: Search results for MUSHROOMS 

LA REVUE GAUCHE - Left Comment: Search results for MDMA 

Australia offers MDMA drug therapy for PTSD, a world first


By Frances Vinall

The Washington Post
June 29, 2023

Mark Walkey, left, and Matthew Piggott look over samples at a University of Western Australia lab, where they are trying to shorten the duration of MDMA effects and eliminate a weak addictive property. 

(Frances Vinall/The Washington Post)

PERTH, Australia — The scientist held up the container of clear liquid and examined it. At a rave, it could be sold by its street names “ecstasy” or “molly.” But here, in a university lab in one of the most remote cities in the world, experts are harnessing MDMA with a therapeutic purpose in mind.

The team of chemists at the University of Western Australia have been working to modify the chemical compound so it can be better used for mental health treatments.

It’s a mission that has suddenly became more urgent, after Australia announced it would become the first country to allow psychiatrists to widely prescribe MDMA to treat post-traumatic stress disorder.

“We will have a lot of attention on us as this rolls out,” said Michael Winlo, the chief executive of Australian biotech company Emyria, which is partly funding the lab’s work.

Australia’s drug regulator, the Therapeutic Goods Administration, surprised just about everybody — including the country’s health institutions — when it ruled that from July, MDMA would be rescheduled from a prohibited to a controlled substance. It will also allow psilocybin, the active ingredient in magic mushrooms, to be used in therapy for treatment-resistant depression.

In doing so, the regulator has turned Australia into a countrywide experiment for other jurisdictions, including the United States, to observe. That is especially the case for MDMA, which no nation has made accessible as a mental health treatment except in limited special circumstances, and which has been of increasing interest to the Food and Drug Administration.

Some experts believe the law change in Australia has happened too quickly and could put patients at risk. But the drugs’ advocates say the move could offer recovery to people with debilitating mental illnesses.

Part of the chemical process to isolate an MDMA analog at the University of Western Australia. (Frances Vinall/The Washington Post)

MDMA floods the brain with feel-good chemicals it produces naturally: serotonin, norepinephrine, oxytocin and dopamine. Meanwhile, fear is curtailed: the amygdala, the brain’s threat response system, quietens down.

It’s a cocktail that, practitioners say, allows a patient to examine past traumatic experiences while typical responses like avoidance, defensiveness and shame are blocked.

A 2021 clinical trial published in Nature of people with severe PTSD found 88 percent showed significant improvement after three sessions of MDMA-assisted therapy. More than two-thirds no longer met the criteria for PTSD two months afterward.

Executive behind ChatGPT pushes for a new revolution: Psychedelics

The U.S.-based Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that has applied for FDA approval, sponsored the research.

There is also ongoing research into MDMA’s potential in the treatment of addiction, social anxiety and, in the case of the UWA-Emyria lab, Parkinson’s disease. In all, the global psychedelics market is projected to be worth more than $10 billion by 2027.

“It’s a pretty hot area,” said Matthew Piggott, associate professor of medicinal chemistry and the head of the lab at the University of Western Australia.

His team is working on shortening MDMA’s half-life (the length of time the drug is in effect) and eliminating a weak addictive property. In the lab, a chemist carefully pours a clear solution into a flask from a series of test tubes. Inside, each contains an analog of the drug. Nearby, a colleague handles a small jar filled with crystalline yellow precursor, while another switches off a contraption with a spinning sphere.

The work has helped turn the state capital Perth, a city with thousands of miles of desert on one side and the Indian Ocean on the other, into an unlikely vanguard of the nascent psychedelic therapies industry.

The state’s favorable regulatory approach has meant Australian-based biotech companies working in MDMA and psilocybin have set up there, said Suzy Madar, an intellectual property lawyer who specializes in health.

Psilocybin as mental health therapy? Here’s what I found.

But the companies were still surprised when the drugs were rescheduled in February.

“It’s not common for the TGA to take a lead in this kind of area,” said Winlo of Emyria. “This puts a lot of attention on the various players in this space to see how we proceed.”

Some experts are concerned Australia has not designed an adequate regulatory framework for this type of treatment.

“Those of us at the coalface doing this research can see how there are going to be very few guardrails in place,” said Paul Liknaitzky, head of clinical psychedelic research at Monash University and co-founder of psychedelic therapy business Clarion Clinics.

“The safety and quality of what is provided is going to depend in large part on the goodwill and competence of the providers, not on authorities and governance,” he said.

The TGA, the drugs regulator that operates at arm’s length from government, made the rescheduling decision. It provided some guidance, but its involvement in overseeing MDMA and psilocybin therapies has now largely ceased.

Instead, human research ethics committees — of which there are about 200 in Australia — will be responsible for assessing psychiatrists’ applications to become authorized prescribers, with final TGA sign-off.

Ketamine for depression: What it feels like and who it can help

One concern expressed by experts is equality of access: Treatments are initially expected to cost about $17,000 for those incorporating standard therapy sessions before and after the drug is taken and multiple dosing sessions lasting about eight hours each.

Another concern is the potential for boundaries to be crossed. Australian clinics planning on offering MDMA therapy for PTSD said they would be adapting from the treatment manual published by MAPS, the organization that has applied for FDA approval.

This method includes “nurturing touch” between the therapist and patient. That could include the patient being “held” by the therapist, or the therapist placing their hand “on an area where the participant is experiencing pain, tension or other physical symptoms.” Withholding touch could be perceived as “abuse by neglect,” it says.

It bars any sexual behavior between therapist and patient and requires prior and ongoing consent for touch. It recommends two therapists, generally one female and one male, be in the room for each dosing session, and that sessions be recorded.

The TGA said it was satisfied appropriate safeguards could be established in the existing system.

But Hester Wilson, alcohol and drug spokesperson for the Royal Australian College of General Practitioners, said the use of “nurturing touch” in an MDMA-assisted treatment worries her.

“If you’ve seen or been with people who are on MDMA, their boundaries are really blurred. They’re so emotionally vulnerable, and just telling everybody that they love them,” Wilson said.

Still, the apparent potential of MDMA to help people who have not responded to other treatment is attractive to many.

At the Pax Centre, a trauma-focused clinic in Perth, co-founders Claire Kullack and Jon Laugharne have undertaken training, along with 18 staff members, and received ethics committee approval for the therapy, using a clinical trial model with recorded, two-therapist sessions and partnering with Emyria, the biotech firm.

About 20 to 30 percent of their clients with PTSD showed little improvement with available treatment methods, Laugharne said. The clinic is cautiously optimistic they may now be able to give some of those people a fuller life.

“We’re at the forefront of something — for once,” he said dryly, referring to Australia. “It’s exciting, and it’s also a big responsibility.”

 

The Return of MDMA

Some doctors are itching to prescribe ecstacy again. How do we avoid the regulatory mistakes of the '80s?

NIKO VOROBYOV | 7.29.2023  REASON

Share on FacebookShare on TwitterShare on RedditShare by emailPrint friendly versionCopy page URL

(Photo 177051537 © Olha Karpovych | Dreamstime.com)

I Feel Love MDMA and the Quest for Connection in a Fractured World, by Rachel Nuwer, Bloomsbury, 384 page, $28.99

In 2006 a Florida man named Zulfi Riza reached out to Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS). Riza was suicidal. He was suffering from PTSD, anxiety, depression, and anger issues. He had tried countless remedies, and he felt that Doblin was his last hope. Riza had heard that an underground network of psychiatrists practiced therapy using the illegal drug MDMA, better known as ecstasy or molly. And Doblin knew of such a therapist.

But Riza also suffered seizures. Should a medical emergency take place during a session, the therapist would be exposed and could lose their license, or worse.

Doblin told him he couldn't help. Riza killed himself the very same morning.

The Drug Enforcement Administration (DEA) had unilaterally outlawed MDMA in 1985 under emergency powers granted to it by Congress. To back up the ban, the agency cited flimsy evidence about MDA, another drug entirely. It was a catastrophic case of government overreach. Zulfi Riza was just one of many people whose lives may have been saved had they not been forced to seek help in secret.

The DEA isn't the only villain in this story. In 2002, a senator from Delaware named Joe Biden proposed the Reducing Americans' Vulnerability to Ecstasy (RAVE) Act. This eventually passed, in somewhat watered-down form, as the Illicit Drug Anti-Proliferation Act. It basically made party organizers liable for drugs consumed on the premises. This made it much more complicated to organize services such as testing partygoers' drugs for dangerous ingredients, as it would implicitly admit there was drug-taking on-site.

At a time when Americans are dying in record numbers from accidentally ingesting substances such as fentanyl, a de facto ban on drug checking in places where Americans take drugs—clubs, festivals—seems especially criminal.

Now that the war on weed is all but lost—federal legalization of marijuana feels like a matter of when, not if—the next battlefront will be over MDMA and other psychedelics. This year Australia allowed licensed therapists to give patients the drug. (It did the same as well for magic mushrooms.) Meanwhile, the Biden administration expects MDMA and psilocybin to be approved therapeutically within the next few years.

Rachel Nuwer's book I Feel Love arrives just in time for the debate. It exhaustively chronicles MDMA's journey from a therapeutic tool to an underground party pill and back to therapy. Although many drug books dwell on the criminal element—killer kingpins, sophisticated smugglers—Nuwer, a respected science journalist, mostly prefers to explore the positive potential of ecstasy and the forces, such as MAPS, seeking to unleash it.

As illicit narcotics go, ecstasy is relatively benign. It does not, as an infamous episode of Oprah suggested, turn your brain into Swiss cheese. Instead, it floods you with an overwhelming sense of love, joy, and empathy—the kind of feeling you get, as Nuwer puts it, "if you were suddenly reunited with a good friend that you hadn't seen in years, and you stayed up all night talking because you were so happy to see each other."

It's precisely these properties that make MDMA such a useful tool for addressing trauma, anxiety, and other mental health issues. Since it's virtually impossible to feel bad while on it, patients can dive deep into traumatic events without being overcome with emotions, and open up to their therapists about things they'd normally keep bottled up.

But as any seasoned tripper will tell you, it's not just the drugs; it's how and where you use them—the set and setting. Someone undergoing MDMA-assisted therapy will get support and guidance from trained professionals. Likewise, someone spending all night pumping his fist in the air at a warehouse party in Brooklyn is unlikely to walk away with any psychological breakthroughs.

Rick Doblin's quest to legalize ecstasy features prominently in the book. Doblin has been fascinated with psychedelics ever since his time studying at New College in Florida, in those days an open-minded institution where students took acid and hung around a clothes-free swimming pool. When the DEA announced its intent to outlaw ecstasy in 1984, Doblin led the counterattack, rallying lawyers, shrinks, and scientists. When that failed and the ban was soon to go into effect, Doblin sold ecstasy pills that had been donated by one of the drug's first kingpins, Michael Clegg, to fund experiments on rats and dogs. Doblin then enrolled at Harvard and interned at the White House to become an insider in government policy.

MAPS has been behind several promising studies showing MDMA's potential in treating combat veterans, sexual assault survivors, and others. Less happily, Doblin and MAPS have been criticised recently for how they handled a sexual abuse case during one of their clinical trials. While creepy therapists are hardly unique to psychedelics, tossing mind-altering chemicals into the mix leaves patients particularly vulnerable. Doblin also has a reputation as a psychedelic evangelist who sometimes gets ahead of himself, which has hurt the cause at times. To her credit, Nuwer doesn't shy away from Doblin's flaws, which will likely get more attention as the debate around psychedelics heats up.

Although Nuwer does an excellent job of breaking down the scientific studies of ecstasy and how exactly it works on the brain, there are still gaps in the research. Some experts have questioned whether enough is known about those for whom MDMA-assisted therapy doesn't work. Could it actually make things worse? Certainly, there are accounts of patients feeling suicidal after a session, a point which Nuwer perhaps covers a little too briefly.

Still, most people aren't taking ecstasy in a clinical setting to cope with survivor's guilt after surviving an IED blast in Fallujah. They're doing it to let loose at boisterous jamborees like Coachella and Burning Man. Nuwer feels no shame describing herself rolling on molly at house parties.

As for ecstasy's alleged dangers: Millions of people have taken the drug since the late '80s, but there hasn't been a corresponding epidemic of brain damage. An infamous study that seemed to show that it caused brain damage in monkeys turned out to be bogus after it was discovered the monkeys had been injected not with molly but with meth.

That isn't to say ecstasy is harmless. Nothing is—even caffeine can kill you in heroic doses. But most of the drug's dangers exist precisely because of the DEA's decision to ban it all those years ago. Nuwer tells the story of Martha Fernback, a 15-year-old English schoolgirl who died in 2013 after swallowing half a gram of 91 percent pure MDMA powder. Like almost everyone else who wants to feel the euphoric bliss of molly, she purchased her gear from an underground pusher, not a licensed pharmacist. She had no idea what dose she was taking, or even if it contained MDMA at all.

Imagine if we played the same stupid games with liquor or beer. Actually, you don't have to imagine. Certain parts of the world have banned booze, so the people there aren't sipping fine wine; they're drinking moonshine or bathtub hooch. Many of them then go blind or die. Rather than crusade against the evils of drugs, Martha's mother joined a campaign called Anyone's Child, calling for a reform of British laws and the legalization of ecstasy.

The ancient Greeks had a word, pharmakon, that can mean either "poison" or "medicine." It's too bad we can't always tell which is which.