Can I Use Psychedelics in My Psychiatry Practice?
More patients are searching for alternative paths to healing. We discuss the legal landscape surrounding psychedelic-assisted therapy in the United States.
The biopharma industry has begun investigating the potential therapeutic benefits of synthetic psychedelics like lysergic acid diethylamide (LSD) and psilocybin. Psychedelics have powerful effects on the brain, leading many to explore their potential for patient treatments — sometimes outside the law’s parameters. So what is all the hype about? Can your psychiatry practice use psychedelics legally?
What Are Psychedelics?
Psychedelics are a loosely grouped class of drugs that can induce altered thoughts and sensory perceptions. Depending on the dosage amount, certain psychedelics, including LSD, can cause visual hallucinations.
All major psychedelic drugs, except ketamine, fall into the Schedule I drug category under the Controlled Substances Act (CSA). Thus, under federal law, It’s illegal to possess, sell, or consume psychedelics. The CSA’s classification means that federal law does not recognize any formally accepted medical use of psychedelics and considers them to pose an elevated risk for abuse.
Despite its Schedule I classification, interest in psychedelics’ medicinal benefits has risen. Psychedelics put patients in an altered state that can, evidence suggests, help process memories and trauma. This type of use is sometimes referred to as “psychedelic-assisted therapy.” The limited studies available have sought to compare its efficacy against antidepressant medications.
In recent years, popular books and media have chronicled the emergence of “underground guides.” These “guides” participate in psychedelic-assisted psychotherapy using LSD, MDMA, psilocybin, and other drugs. To be clear, these underground psychedelic-assisted psychotherapy endeavors are illegal. But widespread accounts of beneficial work with underground guides have contributed to an increased push for the legalization of psychedelics.
Limited Federal Options for Psychedelics in Psychiatry
To legalize psychedelic drugs for therapeutic use, the federal government would need to change the drugs’ Schedule I classification under the CSA. This would likely only happen with widespread public support. Such a change would require creating a legal exemption (similar to the exemptions for alcohol and tobacco) or proving that the psychedelic drug in question has little to no potential for abuse. These represent significant hurdles.
The notable exception to the federal prohibition on psychedelics is ketamine, the only psychedelic drug approved through the traditional medical system. The CSA classifies ketamine as a Schedule III drug, and physicians may prescribe it for off-label use. The Food and Drug Administration (FDA) initially approved ketamine for use in medicine in 1970. Then, in 1999, the CSA designated ketamine as a Schedule III non-narcotic substance. It is marketed as an injectable, short-acting anesthetic. However, since the early 2000s, mental health professionals have increasingly used ketamine-assisted psychotherapy to treat major depressive disorder, post-traumatic stress disorder, substance use disorders, and various anxiety disorders.
Despite ample research demonstrating the efficacy of ketamine and the additional benefits of combining it with psychotherapy, the FDA considers mental health applications of ketamine unapproved or “off-label.” While “off-label” does not mean that ketamine-assisted psychotherapy is illegal, there may be unknown risks to using ketamine for mental health treatment. Thus, informed consent documents must address the potential risks specific to ketamine treatment.
State-Regulated Paths to Legalization
Interest has grown in establishing a state-regulated psychedelic framework for distributing these drugs. Such a framework would resemble the medical cannabis statutory regimes in various states. Notably, Oregon passed Ballot Measure 109, allowing for the “manufacture, delivery, and administration” of psilocybin, a naturally occurring psychedelic drug. Thus, the state is preparing to license and regulate these activities and will begin accepting applications for licensure in 2023.
Legislative proposals are pending in other states as well. For example, Colorado proposed The Natural Medicine Healing Act of 2022, which would establish regulated access to certain psychedelic substances under the supervision of a licensed facilitator. Similarly, Washington filed the Psilocybin Wellness and Opportunity Act earlier this year. If passed, the law would create a system to issue licenses to psilocybin manufacturing facilities, testing labs, service centers, and facilitators.
Despite potential legalization at the state level, psychedelics other than ketamine are still illegal at the federal level. It remains to be seen whether federal officials will enforce the CSA in states that create regulatory frameworks for medical psychedelics.
Get Legal Support
Are you opening or currently operating a ketamine clinic and need legal guidance? Or perhaps you need advice as the psychedelic legal landscape evolves. You should work with an experienced healthcare attorney when considering the use of ketamine or psychedelics at your psychiatry practice. If you live in one of the states where we have licensed attorneys, you can schedule a free consultation.
This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader and should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.