Randomized, parallel-group pilot (n=20) testing psilocybin therapy (25 mg initial; second dose conditional up to 40 mg) for adults with chronic PTSD on an SSRI, comparing trauma-focused psychotherapy versus standard psychological support.
This randomized, parallel-group study at Johns Hopkins CPCR will evaluate feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy in adults with chronic PTSD who remain on an SSRI.
Participants receive about 8 hours of preparatory meetings, two oral psilocybin sessions approximately two weeks apart (initial 25 mg; second session may remain 25 mg or be escalated to 40 mg based on MEQ30 score, clinician judgement, and participant preference), and multiple integration contacts after each session.
Outcomes include clinician- and participant-rated PTSD and mood measures, safety monitoring (vitals, ECG, labs, AEs), and measures of wellbeing and integration; trial compares trauma-focused psychotherapy plus psilocybin versus psilocybin with standard psychological support.
Psilocybin (25 mg initial; second dose conditional up to 40 mg) plus trauma-focused psychotherapy beginning after first psilocybin session.
Second session dose escalated to 40 mg if MEQ30 score <60% or by clinical judgement; participant may decline escalation.
Trauma-focused psychotherapy (includes Cognitive Processing Therapy and in vivo exposure) begins after first psilocybin session.
Standard psychological support (empathic support and session integration) provided to all participants.
Psilocybin (same dosing schedule) with standard psychological support only.
Second session dose escalated to 40 mg if MEQ30 score <60% or by clinical judgement; participant may decline escalation.
Standard psychological support (integration and emotional support) provided to participants.