Safety, tolerability, and feasibility of psilocybin-facilitated treatment for methamphetamine use disorder: A pilot study (Psi-MA)

Pilot single-group Phase I study delivering three 90-minute preparatory psychotherapy sessions, one supervised 25 mg oral psilocybin dosing session (~8 hours), and two 60-minute integration sessions over a 4-week intervention period for participants with methamphetamine use disorder.

Outcomes include safety and tolerability (AEs per CTCAE v5.0), methamphetamine use by timeline followback and urine drug screening at baseline, dosing day, and days 1, 7, and 28 post-dose; adherence supported by session checklists and filming of dosing day.