Phase 2b Study of NPX-5 Psilocybin-Assisted Psychotherapy for Treating Adjustment Disorder in Adults with Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of NPX-5 in psilocybin-assisted psychotherapy PAP for treating adjustment disorder symptoms caused by the stress of a cancer diagnosis. This Phase IIb randomized, double-blind study involves adults aged 18 to 80 who experience anxiety after adjusting to their cancer diagnosis. The goal is to develop scientific knowledge that may lead to new treatments for anxiety and depression following such stressful events. Participants are randomly assigned to receive one of three doses of NPX-525 mg, 10 mg, or 1 mgduring an approximately 8-hour PAP dosing session on Day 14. Those who do not respond by Week 10 and still meet eligibility criteria may receive a second PAP cycle at the 25 mg dose. A maximum of two PAP cycles can be given. The study includes preparation sessions before dosing and follow-up visits after treatment, combining in-person clinic visits and telehealth appointments. Participants will attend screening visits, preparation sessions, dosing and integration sessions, and several follow-up visits up to three months after their final PAP cycle. Assessments include anxiety severity using the Hamilton Anxiety Rating Scale, suicidality monitoring, vital sign checks, and safety evaluations. The study monitors treatment-related adverse events and long-term safety and tolerability of NPX-5, with the final safety follow-up occurring three months after the last treatment cycle.

Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder