State Policies Supporting Evidence-Based Therapeutic Psilocybin Use
June 22, 2023 | Maggie Davis
Psilocybin is a naturally occurring psychedelic compound found in more than 200 fungi species known to cause mystical experiences in people; they are commonly referred to as “magic mushrooms.” Hallucinogenic and psychoactive plants have been used widely in religious and cultural rituals across the globe for centuries, with some religious traditions using psilocybin as part of healing rituals. There is growing interest in the potential therapeutic benefits of psilocybin, which may facilitate new neural connections and offer new ways to treat depression, PTSD, and substance use disorder.
Despite promising research conducted in the 1960s and 1970s, examining the therapeutic benefits of psychedelic drugs was limited in the United States after psilocybin was designated as Schedule I substances, which have “no currently accepted medical use and a high potential for abuse,” under the Controlled Substances Act. With this designation, researchers are required to obtain FDA approval to study the effects of the drug—including whether there could be an accepted medical use.
In 2006, following federal approval to study the use of psychedelics among healthy volunteers without history of prior use, researchers at Johns Hopkins University highlighted the “safety and enduring positive effects of a single dose of psilocybin,” reigniting interest in studying the potential of psilocybin to treat certain mental health disorders. In 2019, FDA granted Usona Institute, a medical research organization, permission to expedite the development of psilocybin for treating major depressive disorder. With interest in expanding psilocybin research and access increasing, states are beginning to legalize psilocybin and authorize its therapeutic use.
Oregon Becomes First State with a Therapeutic Psilocybin Program
In November 2020, voters made Oregon the first state to legalize using psilocybin products when they approved the Oregon Psilocybin Services Act (Measure 109). The ballot measure created the Oregon Psilocybin Advisory Board (OPAB) and instructed the Oregon Health Authority (OHA) to license and regulate the manufacture, transport, delivery, sale, and purchase of psilocybin products as well as providing psilocybin services.
In implementing the new law, OHA established Oregon Psilocybin Services (OPS), which—in addition to its licensing and regulating functions—supports OPAB. In December 2022, following two years of collaboration between OPS and OPAB, along with input from rules advisory committees that include subject matter experts and people with lived experiences, Oregon formally established the administrative rules for its psilocybin program.
In Oregon, a client 21 years or older may only access psilocybin from a licensed service center under the supervision and support of a licensed facilitator. All psilocybin service centers and facilitators must be licensed by OPS, operate at least 1,000 feet away from a school, and receive approval from the local city or county ensuring the facility meets local land use and zoning requirements. The psilocybin products must be cultivated, produced, or processed by licensed manufacturers and tested in a laboratory licensed by OPS and accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP). Additionally, these services can only be provided by licensed facilitators who have (1) taken a state-approved facilitator training program and comprehensive skills exam, (2) passed the state licensing examination, and (3) passed a criminal background check. While psilocybin facilitators must be Oregon residents until 2025, psilocybin services clients are not required to live in the state.
While clients do not need a medical referral or prescription, they must complete a preparation session with a licensed facilitator to give informed consent, review the client bill of rights, and create plans for safety, support, and transportation. If the facilitator and client determine to move forward, the client schedules an administrative session at a licensed service center. During the administrative session a client consumes psilocybin within the licensed service center in a setting designed to be comfortable for experiencing the effects of psilocybin products. Only clients and facilitators are permitted in the area during administration unless the client provides prior written consent for a client support person to be present. A client must stay at the center for a duration determined by the dose they consumed. Later, clients can participate in ongoing integration sessions to review safety and support plans, and get referrals to appropriate peer-support networks and community resources.
In May 2023, OPS issued its first licenses for all four license types. The first clients will gain access to legal psilocybin services in Oregon in June.
Colorado Voters Decriminalize Psilocybin and Authorize Therapeutic Use
In November 2022, Colorado voters adopted Proposition 122 to decriminalize psychedelic plants and create a “Regulated Natural Medicine Access Program.” While Colorado’s proposal also requires clients to be at least 21 years old and have administration sessions conducted in licensed healing centers under the care of a facilitator, the Colorado Department of Regulatory Agencies (DORA) was tasked with establishing the program rather than the Colorado Department of Public Health and Environment (CDPHE).
Although aspects of Proposition 122 have already taken effect—including the decriminalization of psilocybin and other psychedelic drugs—establishing psilocybin healing centers is not expected until 2024. Colorado’s governor has taken substantial steps toward implementing the new law, appointing the 15 members of the Natural Medicine Advisory Board, which will work with DORA to shape the parameters of Colorado’s program. The Board held its first meeting in April 2023 and is expected to issue its first recommendations by September 30, 2023.
State Legislatures Reconsider Psilocybin During 2023 Legislative Sessions
At least 24 state legislatures (AZ, CA, CO, CT, HI, IA, IL, MA, ME, MO, MT, NC, NJ, NM, NV, NY, OK, OR, RI, TX, UT, VA, VT, and WA) considered bills decriminalizing psilocybin and/or establishing therapeutic psilocybin programs during the 2023 sessions. Both Oregon and Colorado enacted legislation clarifying aspects of their psilocybin programs. Oregon SB 965 authorized OHA to adopt rules establishing minimum education and training requirements for psilocybin service facilitators. Colorado SB 23-290 set limits on cultivating psilocybin and clearly authorized DORA to issue regulations to establish healing centers. The Colorado bill also directs CDPHE to coordinate with the Colorado Department of Revenue to assure consistency in rules for psilocybin testing standards and the program’s certification requirements.
Washington enacted SB 5263 in May 2023, creating a psilocybin therapy services pilot program at the University of Washington to provide services to people age 21 or older that are experiencing PTSD, mood disorders, or substance use disorders. Finally, in June 2023, Nevada enacted SB 242 to direct the Nevada Department of Health to establish a Psychedelic Medicines Working Group to study the therapeutic use of hallucinogens like psilocybin.
ASTHO will continue to monitor the effectiveness of psilocybin therapies and state policies supporting its use, providing relevant updates to its members as they become available.