The legal state of psychedelic therapy in the US
Is psychedelic therapy the next big thing in mental health treatment?
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The U.S. Food and Drug Administration recently released new draft guidance, highlighting critical considerations for researchers interested in testing psychedelic treatments for various conditions, including PTSD, depression, and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.
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.
Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
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.
Create an account with the same email registered to your subscription to unlock access.
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Theara Coleman has worked as a staff writer at The Week since September 2022. She frequently writes about technology, education, literature and general news. She was previously a contributing writer and assistant editor at Honeysuckle Magazine, where she covered racial politics and cannabis industry news.
-
'A new era of hurricanes'
Today's Newspapers A roundup of the headlines from the US front pages
By The Week Staff Published
-
How Britain's demographic is changing
A 50-year record population increase was fuelled by greater migration
By Richard Windsor, The Week UK Published
-
The story of Japanese jeweller Tasaki
The Blend A revival in the use of pearls in fashion and jewellery design places heritage brand Tasaki centre stage
By Felix Bischof Published
-
The 'game-changing' treatment for schizophrenia
The Explainer US poised to approve KarXT as new antipsychotic treatment for disorder, which could offer reduced side-effects
By Harriet Marsden, The Week UK Published
-
The audio industry is working to tackle hearing aid stigma
The Explainer Only 1 in 5 people who could benefit from hearing aids use them, according to the Hearing Loss Association of America
By Justin Klawans, The Week US Published
-
How the brain changes during pregnancy
In The Spotlight 'Baby brain' has some scientific basis but not in the way we first thought
By Chas Newkey-Burden, The Week UK Published
-
The EEE virus is spreading in the US
The Explainer The mosquito strikes again
By Devika Rao, The Week US Published
-
Scottish drug deaths: what's gone wrong?
The Explainer The latest figures show an increase in drug misuse deaths in Scotland
By Richard Windsor, The Week UK Published
-
Mushroom edibles are tripping up users
the explainer The psychedelics can sometimes have questionable components
By Devika Rao, The Week US Published
-
Brexit, Matt Hancock and black swans: five takeaways from Covid inquiry report
The Explainer UK was 'unprepared' for pandemic and government 'failed' citizens with flawed response, says damning report
By Harriet Marsden, The Week UK Published