Legislation

Therapeutic Use of Psilocybin

Legislation to create a new state program

BY Jessica L. Nielson, PhD

A conversation many physicians are starting to have

For Minnesota physicians, this question is no longer hypothetical. The state is considering legislation that would establish a regulated therapeutic access program for psilocybin-containing mushrooms, based on recommendations from the Minnesota Psychedelic Medicine Task Force (PMTF). The proposal reflects a broader shift occurring across medicine, public health and policy, one that forces clinicians to balance scientific uncertainty, patient demand and evolving regulatory frameworks. Understanding what is being proposed, what the evidence currently shows and where legitimate concerns remain is increasingly relevant to routine clinical practice.

Why this policy conversation is happening now

The PMTF was charged with reviewing the scientific literature, various legal frameworks and regulatory considerations related to psychedelic therapies. The task force ultimately recommended the creation of a state-regulated clinical program allowing supervised therapeutic use of psilocybin, alongside separate recommendations to fund and expand research and to decriminalize the use and possession of psilocybin mushrooms.

Several forces are converging to drive this discussion. First, treatment-resistant psychiatric and substance-use disorders remain major drivers of morbidity. Many patients cycle through multiple therapies with incomplete or short-lived benefit. Second, psychedelic-assisted therapy research has expanded significantly over the past decade. While still limited compared to traditional psychiatric drug trials and currently available treatments, randomized controlled studies have shown promising signals for certain patient populations, particularly when combined with psychological support.

Third, patients are increasingly aware of psychedelic therapies through media coverage, clinical trial publicity and peer experiences. Some are already pursuing treatment in unregulated settings or outside the United States, raising safety and continuity-of-care concerns. Finally, several states have begun exploring regulated access with models in Oregon, Colorado, and most recently in New Mexico, opening the doors for other states to evaluate whether controlled therapeutic pathways may reduce harm compared to unregulated access. For clinicians, the practical reality is simple: regardless of personal position on psychedelic therapy, patients will continue asking about it, so it would be wise to know more about the risks and benefits, and how to navigate these conversations with patients and whether this is a treatment option physicians may want to explore further.

Much of the work of psychedelic therapy occurs in the sessions after the experience.

What the proposed Minnesota therapeutic access program would do

Patients would require certification from a licensed physician confirming a qualifying medical condition. Screening would evaluate potential contraindications, including psychotic disorders, cardiovascular risk factors and medication interactions. If contraindications are identified, further evaluation could be required before enrollment. From a physician’s perspective, this resembles screening processes used for other higher-risk interventions, including interventional psychiatry treatments or certain specialty pharmacologic therapies. Physicians would then determine if patients are eligible for the program and provide recommendations, similar to how patients are recommended for the medical cannabis program that has been up and running in Minnesota since 2015 with great success.

Structured therapy model

The proposed program emphasizes a multi-phase care model. Following sufficient screening to determine eligibility for patients, treatments are suggested to be conducted in three phases:

Preparation sessions: Patients receive education, risk counseling, and expectation setting. These sessions allow for the patient and facilitator to establish a therapeutic relationship and build rapport and trust through discussing boundaries, preferred methods for support and other important issues that may come up during and after the session.

Supervised administration sessions: Therapy occurs under supervision from a licensed mental health professional with additional certification in psilocybin facilitation. Facilitators will procure the dose for the patient and administer and facilitate the psilocybin session in a clinic or in the patient’s home, with medical monitoring for safety.

Integration sessions: Follow-up sessions help translate experiences into therapeutic behavioral change. Much of the work of psychedelic therapy occurs in the sessions after the experience. Integration sessions allow the material that was uncovered during the psilocybin session to be discussed and processed, and to map out next steps for the treatment plan and journey toward healing, including whether doing another psilocybin session is warranted.

This structure mirrors most clinical trial protocols with psychedelics, as well as the structure being used currently at ketamine clinics branding their services as psychedelic-assisted therapy. The structure of these sessions in addition to the rapport between the patient and the therapist are crucial for good outcomes. Clinical research with psychedelics like psilocybin has shown repeatedly that to maximize the therapeutic benefits, aspects of set (a patient’s mindset and expectations) and setting (the location and competency of the therapist/facilitator) are some of the most important components of the therapeutic process.

Regulated supply chain and quality control

The program would license cultivation and testing facilities to ensure standardized dosing, potency consistency and contaminant screening. While most of the clinical trials with psilocybin use a pharmaceutical/synthetic version cleared by the Food and Drug Administration for use in clinical trials, this program, like those already available in Oregon and Colorado, will use naturally grown psilocybin mushrooms. There are over 200 different species of psilocybin-containing mushrooms with different potencies that require adjustments in source material used for treatment sessions. Other states have developed the infrastructure for testing and dosing psilocybin mushrooms so they can be administered accurately. The therapeutic dose from clinical trials ranges from 25-50 mg of psilocybin. This sounds like a small dose relative to how “magic mushrooms” are discussed in the lexicon of people who use them, often referring to a “heroic dose” as 5-7 grams of dried whole mushroom that may help someone achieve a peak or breakthrough experience. Yet depending on the species of the mushroom, dosing by weight (e.g., just eating a handful of mushrooms) may yield drastically different experiences in terms of subjective intensity and the actual concentration of psilocybin that a patient will experience.

Infrastructure and protocols from other state programs exists for testing, dosing and administering to patients, allowing the regulation and supply to help reduce risks. Additionally, there would be a strict chain of custody over who has access to mushrooms being used for therapy to prevent diversion and abuse of the supply, with similar protocols for dispensing controlled substances that are being used for clinical trials.

The evolving role of physicians

Physicians would likely engage in several roles, even if not directly administering psilocybin therapy. These include:

• Diagnostic certification for qualifying conditions
• Medical risk screening and contraindication assessment
• Consultation within multidisciplinary care teams to increase safety oversight and reduce liability risk
• Participation in outcomes monitoring and public health data reporting
• Potential participation as psilocybin facilitators (with additional training and consideration of DEA/prescribing risks)

Some physicians may pursue facilitator training, though participation is expected to vary widely by specialty and practice environment. It should be noted that psilocybin is currently a schedule 1 drug under the Controlled Substances Act, so involvement in the program where administration or handling of psilocybin occurs may put DEA prescribing licenses at risk. Like medical cannabis programs, these interventions are not being made available as prescriptions or to be dispensed at pharmacies that store and dispense other controlled substances. Physicians and prescribers may recommend eligible patients for the program; however, risk around current licenses should be evaluated depending on level of involvement that physicians choose to have with the program.

Current evidence: encouraging but incomplete

Current research suggests psilocybin-assisted therapy may show benefit for certain conditions, particularly treatment-resistant depression, some anxiety disorders and substance-use disorders when delivered in structured therapeutic settings. A thorough review of clinical trials with psilocybin are covered in the PMTF final legislative report (2025).

Nearly 40 other states have introduced legislation to expand access to psychedelic medicines like psilocybin.

Physicians, however, should recognize important limitations about the evidence from psilocybin clinical trials. This includes:

• Smaller study populations compared to traditional psychiatric trials
• Methodological challenges, including placebo blinding
• Limited long-term durability data

Most data come from underground use and submission as experience reports to databases such as Erowid and Shroomery.

Potential advantages of a regulated therapeutic access program

For patients who have failed multiple standard treatments, even moderate improvement can significantly affect function and quality of life, and psilocybin therapy may expand the options for treatment-resistant patients. Patients are already accessing psychedelic substances outside formal medical systems, and regulated programs could provide medical screening, standardized dosing and emergency response capability, as well as move patients from unregulated to regulated environments.

Structured outcome monitoring could help clarify long-term safety and effectiveness and inform future clinical standards, thus accelerating evidence development for accepted medical uses of psilocybin. In addition, the structured therapy model aligns with emerging evidence that context and therapeutic alliance influence outcomes for patients, allowing for the integration of pharmacologic and psychotherapeutic care.

Potential risks and concerns physicians may reasonably have

Compared with standard psychiatric treatments, evidence remains limited in duration and scale for psilocybin-assisted therapy according to FDA approval standards. The dearth of appropriate clinical data is largely due to psilocybin’s being a schedule 1 drug, making the research and potential access challenging. Schedule 1 status poses risks for prescribers and ongoing uncertainty regarding institutional participation, as well as malpractice considerations.

When it comes to risks for patients, considerations include acute psychological distress, cardiovascular complications in vulnerable patients, symptom destabilization in bipolar or psychotic spectrum disorders, muscle spasms in patients with spinal cord injury and medication interaction risks. These risks reinforce the importance of medical screening and collaborative care.

Additional considerations

Questions remain regarding long-term credentialing, training standards and division of clinical responsibility between facilitators and physicians. Other state programs have demonstrated potential challenges including high cost, workforce limitations and uneven geographic access.

Several cultural and ethical factors should be considered with psilocybin therapy, such as engagement and reciprocity with Indigenous communities. Also, accessibility for medically complex or mobility-limited patients, special considerations around access and care for veteran mental health needs and broad public education rooted in science and public health.

Second clinical vignette: PTSD and patient access realities

A 36-year-old veteran establishes care after relocating to Minnesota. PTSD symptoms persist despite pharmacologic and psychotherapeutic treatment. The patient reports peers traveling internationally for psychedelic therapies and asks whether Minnesota will offer supervised options.

Regardless of policy outcome, physicians will increasingly encounter patients navigating these decisions.

Three key takeaways for Minnesota physicians

1. The proposal is designed as a therapeutic public health framework. The program emphasizes screening, supervision, regulated supply and monitoring rather than commercial access.
2. Evidence supports careful exploration, not uncritical adoption. Psilocybin therapy may represent a meaningful option for some patients, but long-term data remain limited and data are evolving out of other state-regulated programs.
3. Physician engagement will shape safety and clinical credibility. Participation in screening, monitoring and care coordination will likely determine how safely the program evolves.

Final perspective

Psilocybin therapeutic access represents an intersection of psychiatry, neuroscience, addiction medicine and public health policy. For physicians, the most important question may not be whether psychedelic therapies will enter clinical practice, but how they can be integrated safely, ethically and scientifically into modern health care systems. The push to develop a psilocybin therapy program in Minnesota signals a broader shift toward exploring new therapeutic modalities for chronic and treatment-resistant conditions. Physician engagement, whether it be supportive, cautious or skeptical, will likely influence how these therapies develop within Minnesota’s health care system. We hope that influence can be leveraged to help expand access to more options for healing for providers and patients in Minnesota.

Nearly 40 other states have introduced legislation to expand access to psychedelic medicines like psilocybin. Sometimes those efforts are impeded due to pushback from physicians who are not well informed on the clinical trials and therapeutic potential of psychedelic medicines and oppose such access simply because they haven’t received FDA approval yet and want to express an overabundance of caution. Those who are knowledgeable about the science, research and safety profile of psilocybin therapy, however, can be powerful advocates for helping to convince skeptical physicians and legislators about the promise of this type of therapy so we can implement sensible legislation and access programs that expand the toolkit providers can use to help support the complex care needs of their patients.

Jessica L. Nielson, PhD, is an adjunct assistant professor in the University of Minnesota department of psychiatry & behavioral sciences. She is also the chairperson of the Psychedelic Medicine Task Force and president of the Psychedelic Society of Minnesota. 

Note this article was written with assistance from ChatGPT

Related Links:

nielsonlab.umn.edu/

www.health.state.mn.us/people/psychmed/index.html

www.oregon.gov/oha/ph/preventionwellness/pages/oregon-psilocybin-services.aspx

dpo.colorado.gov/NaturalMedicine

www.nmhealth.org/about/mcpp/mpp/

www.lrl.mn.gov/docs/2024/mandated/241756.pdf

erowid.org/experiences/

https://www.shroomery.org/