Australia Legalizes Therapeutic Use of MDMA and Psilocybin

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.

Canada, Israel, and the United States have enacted compassionate-use programs for psychedelic-assisted mental health therapy.

"As the funder and sponsor of the most advanced research of a psychedelic-assisted therapy, MAPS is encouraged to see a fourth nation provide access to some psychedelic-assisted therapies," Rick Doblin, the group's founder and director, said in a statement. "Australians who have endured long-standing psychological suffering will soon have the opportunity to consider emerging treatments backed by rigorous clinical research: MDMA-assisted therapy for PTSD, with two successful phase three studies, and psilocybin-assisted therapy for treatment-resistant depression, currently in phase 2 clinical trials."

"Australia's policy change is one that every country should consider: suffering people, regardless of nationality, need more opportunities to access novel treatments," Doblin added. "We hope that this announcement will encourage more international discussion and collaboration towards access to psychedelic therapies and comprehensive drug policy reform."