Dose escalation decision support

The manuals converge on dose escalation as a structured, criteria based process rather than a simple automatic increase. Across the extracts, escalation is tied to checking whether a peak experience occurred, whether the prior dose was safe and well tolerated, and whether the participant’s response and clinical observations support moving on to the next dose. Several sources also place the facilitator or therapist in a supporting role, with observations and documentation feeding into a broader decision process that may include medical review, joint agreement, or protocol defined safety review. They also agree that timing and sequence matter. The GH001 materials describe fixed dose sequences with 3 hour spacing, while the psilocybin trial design and the BPL-003 protocol both frame later dosing as dependent on earlier session response and safety review. The 2026 GH001 trial adds a specific peak experience threshold, PES score at least 75, and requires psychoactive effects to have substantially subsided, with vital signs and FEV1 acceptable before additional dosing. The manuals differ in how explicit and how clinical the escalation rules are. The GH001 sources give the clearest stepwise regimen, with 6 mg, 12 mg, and 18 mg doses and mutual agreement between participant and medical doctor. The BPL-003 document is less about a participant driven peak experience and more about SRC review of safety, tolerability, PK, and PD data before escalation.