Abbotsford

Researchers are investigating the safety and effectiveness of NPX-5 in psilocybin-assisted psychotherapy (PAP) for treating adjustment disorder caused by the stress of a cancer diagnosis. This Phase IIb study involves adults aged 18 to 80 years who experience anxiety related to adjusting to their cancer diagnosis. The study aims to develop scientific knowledge that could support new treatments for anxiety and depression following acute stressful events like cancer diagnosis. Participants are randomly assigned to receive one of three doses of NPX-5 (25 mg, 10 mg, or 1 mg) during an approximately 8-hour PAP dosing session on Day 14. Before dosing, participants complete three preparation therapy sessions, some via telehealth and one in person. The study includes clinic visits on Day 1, Day 13, Day 14 (dosing), Day 15 (integration), and Week 10 (Day 70) post-randomization, with telehealth sessions for preparation, integration, and follow-up. Non-responders at Week 10 who still meet eligibility criteria may receive a second PAP cycle at 25 mg NPX-5. A maximum of two PAP cycles can be administered. During the study, participants undergo screening and baseline assessments, including psychiatric and medical evaluations. Researchers monitor anxiety severity using the Hamilton Anxiety Rating Scale and assess safety through vital signs and suicide risk with the Sheehan Suicide Tracking Scale at various time points up to three months after the final PAP cycle. The study uses clinic visits and telehealth calls to support participants, tracking treatment effects, safety, and tolerability throughout the study period.