1980-present / Psilocybin

An Update (NIDA Research Monograph 146)

Proceedings of a 1992 NIDA technical review on hallucinogen research, prompted by rising LSD use among teenagers. Includes Rick Strassman's account of the regulatory process (IRB, DEA, FDA) for his DMT study, the first human hallucinogen study approved since the early 1970s.

Oregon's 2020 ballot measure created the first US state-licensed psilocybin services program. The findings cite FDA's breakthrough-therapy designation for depression, and the statute establishes licensed service centers and facilitators rather than unsupervised legalization.

Considerations for Clinical Investigations (Guidance for Industry)

FDA guidance (July 2026) for sponsors developing psychedelics—5-HT2A agonists including psilocybin and LSD, plus MDMA—as approved medicines. It addresses the regulatory pathway for Schedule I drugs in clinical trials and identifies methodological challenges: perceptual effects complicate blinding ('functional unblinding'), and the independent contribution of psychotherapy paired with dosing remains uncharacterized.