The legal state of psychedelic therapy in the US
Psychedelic-assisted therapy may become more mainstream soon due to recent legislative efforts and promising research, offering an alternative for specific mental health conditions. It may be the "next big trend in mental health treatments," and experts say we can expect a rising buzz about the "emerging wellness trend" soon, per USA Today.
Dr. Matthew W. Johnson, a professor of psychiatry and behavioral sciences at Johns Hopkins and a psychedelics expert, has recently seen a "dramatic increase in interest" in the area and believes it's "only going to increase" over the next few years. The increase in clinical trials and legislative wins have led schools to focus on training future therapists and practitioners who will facilitate the sessions.
The U.S. Food and Drug Administration recently released new draft guidance, highlighting critical considerations for researchers interested in testing psychedelic treatments for various conditions, including PTSD, depression, and anxiety. This is the first time the agency has outlined trial conduct, data collection, and safety precautions for researchers studying psychedelics as medicine. The guidance covers prospective studies on "classic psychedelics," like psilocybin and LSD, or "entactogens" or "empathogens" like MDMA. The FDA filed the document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced a bill that called for the agency to issue clinical trial guidelines for psychedelic-assisted therapy.
Is psychedelic therapy legal in the U.S.?
Psychedelics have been "staunchly outlawed" in most parts of the world and remained "culturally taboo and scientifically off-limits" for much of the last century, Webb Wright said in Double Blind Magazine. Classic psychedelics like mescaline, LSD, psilocybin and DMT have been classified as Schedule 1 substances by the U.S. Drug Enforcement Agency (DEA) since 1970, and MDMA, the synthetic psychedelic also known as ecstasy or molly, was added to the list in 1987. While they remain illegal on the federal level, "clinical trials, deprioritization and limited forms of state-level adult-use legalization have forged the first pathways for psychedelic therapy within the country," Wright added.
In 2017, the Food and Drug Administration granted Breakthrough Therapy status to MDMA-assisted therapy for PTSD and did the same the next year with psilocybin therapy for treatment-resistant depression. The designation is meant to expedite the process of gaining FDA approval. At the end of 2022, the American nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) completed a second phase-three trial on MDMA therapy for PTSD, a step widely considered the "last hurdle to clear" before applying for FDA approval, Time reported. Rick Doblin, MAPS' founder and executive director, said the group plans to apply for FDA approval based on the trial data, putting them on track for the drug to be approved as soon as 2024.
While several American cities have decriminalized personal psilocybin use, Oregon became the first state to legalize psilocybin use under strict supervision in 2020 and was followed by Colorado in 2022. Other states have proposed similar bills to legalize psilocybin, including California, Connecticut and New Jersey.
Oregon's Measure 109 took effect at the beginning of 2023, so many are looking at the state's program as a "real-world experiment" for psychedelic medicine. "One small hiccup: Oregon hasn't legalized psychedelic medicine," Grace Browne said in Wired. The law specifically permits "supported adult use" of psilocybin but does not require or even allow any medical referral. While people can legally trip in the presence of a licensed facilitator, Browne added, "psychedelic-assisted therapy it is not." Clients must sign a consent agreement that states they "understand that psilocybin services do not require medical diagnosis or referral and that psilocybin services are not a medical or clinical treatment."
The FDA-approved anesthetic ketamine falls in a lower category than other hallucinogenic drugs and is generally legal to prescribe throughout the country. While some might debate over whether an anesthetic counts as a psychedelic, its hallucinogenic properties are similar enough to psychedelic treatments to be considered in the same category. The FDA approved a ketamine nasal spray for treatment-resistant depression in 2018, and several companies operate ketamine therapy centers nationwide.
How does legalization compare to other countries?
On Feb. 3, Australia became the first country to recognize psychedelics for medicinal use legally after regulators announced that medicines containing MDMA or psilocybin could be used to treat PTSD and treatment-resistant depression in controlled settings. While some countries, like Jamaica and the Netherlands, already have legal psilocybin clinics and retreats, Australia is the first to offer it broadly as an approved medical treatment. While the Australian Therapeutic Goods Administration (TGA) has yet to approve any psychedelic-based medication, the organization says the reclassification will allow "authorized psychiatrists to access and legally supply a specified 'unapproved' medicine containing these substances to patients under their care for these specific uses."
Regulations in Canada, Israel and Switzerland allow clinicians to prescribe certain psychedelics in limited circumstances for patients with severe ailments. Ayahuasca, another hallucinogen anecdotally known for its therapeutic potential, is legal in Brazil, Costa Rica, Mexico and Peru, and retreats draw tourists from around the world.
Update June 26, 2023: This article has been updated throughout.
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