Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day). At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

NCT Number	NCT07072728
Lead Sponsor	Psyence Australia Pty Ltd
Conditions	Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer of Endometrium, Cancer of Kidney, Cancer of Prostate, Cancer of the Breast +3 more
Enrollment	87 participants
Start Date	2025-10-01
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-03