Legal Psychedelic Clinics in the U.S.: What is Legal Now
In the United States, a paradigm shift in mental health treatment is underway, with legal psychedelic clinics pioneering innovative approaches. Here's a brief overview of the types of legal psychedelic clinics operating in the U.S. today and what could be legalized in the future.
Ketamine Clinics
Found across the country, ketamine clinics provide treatment for conditions like depression and anxiety. Despite ketamine being approved by the FDA for use as an anesthetic, it is not approved for mental health indications. Thus, treatment for conditions like depression is usually not covered by insurance and is considered 'off-label' use of ketamine. As a Schedule III substance, ketamine requires a prescription from a licensed health provider. It can be administered in multiple forms but is often administered intravenously, intramuscular injection, intranasal, and with sublingual lozenges.
Psilocybin-Assisted Service Centers
As the potential health benefits of psilocybin gain greater recognition, Oregon and Colorado have decriminalized the possession of psilocybin-containing mushrooms, creating legal avenues for regulated use. The Oregon Psilocybin Services is a branch of the Oregon Public Health Authority providing licenses to qualified candidates to be service providers. In Oregon, the term "psilocybin services" pertains to the preparation, administration, and integration sessions facilitated by a licensed professional. The psilocybin products utilized must be grown or manufactured by a licensed psilocybin producer and can solely be dispensed to clients within a licensed psilocybin service center during an administration session. These services are open to individuals aged 21 and above and do not necessitate a prescription or medical referral.
In Colorado, the Natural Medicine Regulation and Legalization bill was passed on May 20, 2023. Natural medicines currently only refers to psilocybin or psilocyn and in 2026 may expand to include: dimethyltryptamine, ibogaine, and mescaline (excluding peyote). The bill introduces regulatory amendments for natural medicine and products. It establishes the Natural Medicine Division of the Colorado Department of Revenue, which regulates facilitators and the issuing of licenses for facilitators, creates rules and regulations for facilitation, and is responsible for investigations and disciplinary authority. In addition, the bill outlines rules for legal use and creates a federally recognized American tribes and Indigenous community working group. This group will make recommendations to the director of the Natural Medicine Division and its board. Beginning on June 30, 2024, the Natural Medicine Division will in coordination with the state licensing authority, publish a public report on the implementation and administration of the bill. By December 31, 2024, rules to establish qualifications, education, and training requirements for facilitators will be adopted and applications for licenses, registrations, permits, and certifications will be reviewed with priority given to Colorado residents.
MDMA-assisted Therapy Clinics
If the FDA approves MDMA for the treatment of PTSD, we will see the development of MDMA-assisted therapy clinics. After a series of clinical trials, MAPS Public Benefit Corp, filed an application with the FDA for MDMA in combination with therapy to treat post-traumatic stress disorder. The protocol includes a preparatory phase involving medication tapering, preparatory sessions, and baseline assessments. During the eight-week treatment period, participants experienced two monthly dosing sessions.
It's crucial to note that the legal landscape surrounding psychedelics is complex and rapidly evolving. Regulations vary by state, and businesses involved in the industry should be well-informed about local laws and seek counsel from reputable firms. As the field of legal psychedelic therapy evolves, it holds promise for those seeking transformative mental health treatments within the framework of U.S. regulations. To learn more about how your business can navigate the psychedelic legal landscape, email [email protected].
