Maryland stands at a crossroads familiar to policymakers nationwide: how to respond to growing evidence that psychedelic substances may offer breakthrough treatments for mental health conditions—even as the federal policy pathway remains uncertain, the evidence base is still evolving, and early state experiments are revealing both promise and pitfalls.

The Hopkins Business of Health Initiative (HBHI) today released an independent, evidence-informed report to the Maryland Task Force on Responsible Use of Natural Psychedelic Substances to help policymakers weigh options for safe, equitable, and evidence-driven access to psychedelics and to design programs that can be implemented and rigorously evaluated over time.

Authored by a team of Johns Hopkins researchers—Katherine Cheung, Michael Darden, Matthew Eisenberg, Mario Macis (corresponding author), and Daniel Polsky—the report synthesizes clinical, economic, and policy evidence to outline how Maryland might unlock potential benefits while managing risks through screening, supervision, and rigorous evaluation.

The urgency is clear. As of 2022, an estimated 23.1% of U.S. adults experienced any mental illness, 6% had serious mental illness, and the prevalence of depression among adolescents and adults has risen roughly 60% over the past decade. For the subset with treatment-resistant depression, major depressive disorder, or chronic, severe PTSD—populations that have exhausted standard therapies—psychedelics represent one of the few options that have shown clinically meaningful, sometimes rapid, and durable symptom improvements in small, controlled studies with structured psychotherapy.

Yet psilocybin and MDMA remain classified as Schedule I controlled substances, and federal approvals remain limited (e.g., the FDA declined to approve MDMA-assisted therapy in 2024 pending more evidence).

Against this backdrop, states are testing diverse policy models. Oregon launched the nation's first licensed psilocybin services program in 2023; Colorado and New Mexico have enacted their own frameworks; and jurisdictions from Washington, D.C. to Ann Arbor have decriminalized possession. Each model reflects different priorities—clinical care vs. wellness access, safety vs. speed, equity vs. revenue—and each generates new questions about what works, for whom, and at what cost.

This new report provides Maryland's Task Force on Responsible Use of Natural Psychedelic Substances with a structured, evidence-informed roadmap that aligns policy with purpose, outlining each option’s potential benefits and risks, operational requirements, and the data infrastructure needed for rigorous evaluation.

Key insights from the report:

  1. Match policy to purpose. The optimal pathway depends on Maryland’s goals. A state-authorized medical/therapeutic model best aligns with clinical aims under strong safety controls, while a supervised adult-use framework can support well-being and personal-growth goals under close regulation. Decriminalization, by itself, does not unlock clinical or well-being benefits and lacks safeguards; commercial sales similarly expand access but do not provide screening or supervision. However, both can serve as complements—alongside medical/therapeutic care and supervised adult use—if paired with strong guardrails and ongoing evaluation.
  2. Build on, but go beyond, existing evidence. Clinical studies suggest meaningful benefits for conditions like TRD and PTSD when psychedelics are delivered with careful screening and supervision, but the evidence remains limited. Maryland has a real opportunity to generate high-quality real-world evidence that complements clinical trials and informs decisions in Maryland and other states. Implementation should be designed with evaluation in mind, enabling experimental and quasi-experimental methods (e.g., randomized waitlists, staggered rollouts, regression discontinuity, difference-in-differences).
  3. Learn from Oregon’s experience and plan for modest scale and affordability challenges. Oregon’s supervised adult-use model shows that a regulated system can operate safely but at modest scale. Service centers have become the main bottleneck. High prices, local opt-outs, and federal tax constraints limit access and sustainability, underscoring the need for pragmatic expectations, equity supports, and strong safety monitoring.
  4. Right-size capacity and market expectations. Plan for limited early scale under both therapeutic and supervised adult-use pathways, with access constrained by delivery capacity and affordability. Even if commercial sales were authorized, psilocybin participation and spending would remain a small fraction of Maryland’s cannabis market. Pair any rollout with affordability supports and standardized data collection to track equity and outcomes.
  5. Design for evaluation from day one. Whatever model the state adopts, success depends on embedding evaluation into implementation—linking privacy-protected data through Maryland’s health information exchange (CRISP), publishing transparent dashboards, and using rigorous quasi-experimental methods to compare outcomes and costs across policy alternatives. This “evaluation-first” design ensures Maryland can scale what works, adjust as new evidence emerges, and contribute valuable knowledge to inform other states’ and federal policy.

“No single model optimizes all goals,” said lead author Mario Macis. “Maryland can make progress by matching policy to purpose—piloting targeted pathways, building safeguards, and embedding rigorous evaluation so rules can adapt as more evidence accumulates.”

With the proper infrastructure—standardized measures, privacy-protective data linkage, public dashboards, and a commitment to learning—Maryland can make progress on multiple fronts: expanding access for those with the greatest need, generating the real-world evidence the field requires, and ensuring that policy adapts as knowledge accumulates.

Download our report: Psychedelic Policy for Maryland: An independent report offered to the Task Force on Responsible Use of Natural Psychedelic Substances (October 8, 2025).

Read the report from the Maryland task force: Maryland Natural Psychedelic Substance Access Program: A Pathway Forward (November 4, 2025)

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Disclaimer
HBHI supported this independent analysis; views are the authors’ and do not represent Johns Hopkins University or its schools.