RecruitingPhase 2NCT07072728

Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.

Sponsor

Psyence Australia Pty Ltd

Enrollment

87 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer of the Breast Cancer Adjustment Disorder Adjustment Disorder With Anxious Mood Cancer Cachexia Cancer of Endometrium Cancer of Kidney Cancer of Prostate Cancer of Stomach Cancer Melanoma Skin Cancer Pancreas

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests psilocybin-assisted psychotherapy (guided sessions using a psychedelic compound) for cancer patients who have developed adjustment disorder — a stress-related mental health condition triggered by their cancer diagnosis or treatment. The goal is to reduce anxiety and emotional distress in people struggling to cope with their cancer. **You may be eligible if...** - You are 18 to 80 years old - You have been diagnosed with cancer - You have been diagnosed with adjustment disorder (scoring 47.5 or higher on the ADNM-20 scale) - You have moderate anxiety (Hamilton Anxiety Scale score of 18 or higher) **You may NOT be eligible if...** - You have active or advanced cancers excluded by the study (e.g., brain tumors or certain metastatic cancers) - You have a personal or family history of psychosis or schizophrenia - You are taking medications that could interact with psilocybin - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsilocybin therapy

Following a screening period, eligible participants will undergo one cycle of psilocybin-assisted psychotherapy (PAP). Non-responders at Week 10 who continue to meet eligibility criteria will be offered a second PAP cycle at the 25 mg NPX-5 dose. A maximum of two PAP cycles may be given. Long-term follow-up will include a visit at Month 3 following the final PAP cycle.