What It Takes to Run a Responsible Psychedelic-Assisted Therapy Site

Psychedelic-assisted therapy trials — for MDMA, psilocybin, and related compounds — impose infrastructure requirements that go well beyond a typical psychiatric protocol. Dosing sessions can run 8 to 12 hours, require continuous clinical observation, and depend on trained therapy facilitators working within a controlled physical environment.

Under the medical oversight of Dr. Mary Okafo, board-certified psychiatrist and our Medical Director of Behavioral Health & Psychiatry, we built a dedicated psychedelic therapy suite designed around those requirements: a controlled environment with observation capability, safety equipment, and an extended-stay room purpose-built for full-day dosing sessions.

Regulatory infrastructure runs in parallel with the physical space. An active DEA Schedule I researcher license, held via our Principal Investigator, is a prerequisite most sites never pursue given the administrative burden — but it is what allows Mount Clinical Research to support Schedule I compound trials directly rather than through a third-party research partner.

Integration support — structured follow-up sessions after a dosing day — is treated as a clinical requirement, not an optional add-on, reflecting the emerging consensus among psychedelic researchers that post-session integration meaningfully affects both safety outcomes and data quality.