Australia approves psychedelics for some PTSD and depression patients

The trippy hippie era is making a comeback—in Australia. As of July 1, Australian psychiatrists can prescribe MDMA, also known as ecstasy, for post-traumatic stress disorder and psilocybin, the psychoactive component in hallucinogenic mushrooms, for severe depression. Australia’s equivalent to the U.S. Food and Drug Administration, the Therapeutic Goods Administration (TGA), approved both medicines in February, citing “the lack of options for patients with specific treatment-resistant mental illnesses.”

While Australia is the first country to create a framework for medical use of psychedelics at the national level, clinical trials are also underway in Canada, the United States, and Israel. In Canada, the province of Alberta began regulating an array of psychedelic drugs for therapeutic use last year. In the United States, Oregon legalized psilocybin service centers in 2020, and Colorado decriminalized the drug, among others, for both personal and medical use in 2022.

Advocates of psychedelic drugs believe they provide therapeutic benefits. But some experts say more evidence is needed to demonstrate the drugs’ efficacy and safety. Still others doubt psychedelics are the best way forward for treating severe mental health problems.

Research exploring the mental health benefits of psychedelic drugs is relatively new. Results of a 2021 phase 3 clinical trial suggest that short-term therapy with MDMA can reduce or even eliminate PTSD symptoms. In 2022, some participants in a phase 2 clinical trial reported alleviated depression symptoms after taking psilocybin.

Under Australia’s new rule, only psychiatrists approved by both a human research ethics committee and the TGA’s authorized prescriber program are allowed to administer psychedelics.

The TGA is still determining how psychedelic-assisted therapy will be administered. For now, patients can only receive prescription MDMA or psilocybin while being monitored by a psychiatrist and also receiving talk therapy. Patients are only eligible if they’ve tried all standard treatments for PTSD or severe depression without improvement.

Australia’s new rule goes against the advice of the TGA’s advisory committee. Meeting minutes obtained by ABC News’ Background Briefing listed the committee’s concerns, including broad categories for treatment-resistant mental illness and the lack of phase 3 trials.

Angela Allbee, manager of Oregon Psilocybin Services (OPS), said Oregon does not require facilitators to have medical training, but they must complete a psilocybin facilitator training program and pass an exam administered by OPS. Patients 21 or older must complete a preparation session with a licensed facilitator before being prescribed psilocybin. Anyone taking lithium or experiencing active psychosis or ideation of harm to self or others is ineligible to receive psychedelic prescriptions. Once approved, clients receive psilocybin at a licensed service center. “This is the only time a client can purchase or consume psilocybin product,” Allbee said. The licensed facilitator follows up with the client within 72 hours.

After two deployments to Iraq, Matt Gangloff experimented recreationally with psilocybin to treat his severe PTSD. He says his nightmares and intrusive thoughts ceased after taking the drug 15-20 times over several years. “[Psychedelics] present different possibilities and a different way of looking at things,” he said. “And in that space, you can kind of make the necessary lifestyle adjustments you need to make.”

But Gangloff fears people will rely solely on psychedelics rather than coupling them with needed lifestyle changes, like getting enough sleep, eating healthy, and exercising regularly. He’s more open to controlled administration in a clinical setting.

Dr. David Hellerstein, professor of clinical psychiatry at Columbia University and director of the Depression Evaluation Service at the New York State Psychiatric Institute, said Australia may be moving too fast in approving psychedelic drugs. He explained that phase 3 clinical trials for MDMA in the U.S. are still under review by the FDA, while phase 3 trials for psilocybin are just getting started. “Jumping a step is, I think, taking additional potential risks,” he said. He hopes Australia will set up a data collection system to record adverse events.

Hellerstein is excited about the use of psychedelics to treat severe mental health conditions, but he said much is still unknown. Phase 3 clinical trial data could clarify whether patients should stop taking antidepressants prior to psilocybin treatment and provide insight into risks for people with complex psychiatric diagnoses. Hellerstein explained that people with bipolar disorder have been excluded from clinical trials, but many people with treatment-resistant depression are also bipolar. “You don’t want to provide drugs that increase risk for extremely vulnerable populations,” he said. “But we don’t even know how vulnerable they are.”

Christian counselor Mark Shaw, founder and president of the Addiction Connection, is more cautious about the benefits of psychedelic treatment. He thinks too little is known about psychedelics’ long-term and side effects. He also worries that bad trips could worsen users’ mental health conditions. “If I’m in a bad frame of mind, what if I take this and it intensifies that bad frame of mind?” he asked. “So, could it make people more suicidal?”

Shaw recounted his experience working at a women’s residential program where many of the women were victims of extreme abuse and violence. He tried to help these women work through traumatic flashbacks without the use of chemicals, and he questions whether psychedelic treatment could prevent people from facing painful root causes often associated with their mental health diagnoses. Dealing with the trauma took work and was painful for his clients. “But then [I saw them] let God redeem it, and God use it as part of their story,” he said. “They could help others.”