Psilocybin-Assisted Therapy for People with Cancer
Adjustment disorder (AjD) is a stress-related mental health condition that can significantly affect quality of life for people diagnosed with cancer. This study is evaluating the safety and effectiveness of psilocybin-assisted therapy in adults living with cancer who are experiencing moderate to severe AjD.
Study overview
Adjustment disorder (AjD) is a stress-related mental health condition that can significantly affect quality of life for people diagnosed with cancer. This study is evaluating the safety and effectiveness of psilocybin-assisted therapy in adults living with cancer who are experiencing moderate to severe AjD.
The investigational treatment involves a single oral dose of a psilocybin-containing capsule (NPX-5) combined with psychological support. Psilocybin is being studied for its potential to support emotional wellbeing, reduce psychological distress, and improve overall coping in patients facing serious health challenges.
Am I eligible?
You may be eligible if:
- You are aged 18–80
- You have been diagnosed with cancer
- Experiencing significant distress associated with a cancer diagnosis
- You are using contraception (unless post-menopausal)
- You are willing to commit to a 3-month study
What taking part involves
If eligible, participants will be on the study for approximately 3 months. The study includes 6 in-clinic visits and 6 phone calls, scheduled across screening, baseline, treatment, and follow-up phases. Some appointments will also be completed remotely.
Study appointments will take place in clinic and remotely. Appointment duration will vary depending on the visit, ranging from 1–3 hours, with the medication appointment lasting approximately 8–10 hours to allow for close monitoring by the clinical team.
The investigational product, a psilocybin-containing capsule (NPX-5) will be taken as part of a single dosing session. This is a blinded, comparator-controlled study, which means participants will be randomly assigned (1:1:1) to receive one of three possible doses: 1 mg, 10 mg, or 25 mg of psilocybin. Neither participants nor the study team will know which dose has been given. All participants will receive five capsules to ensure consistency in the dosing experience.
Participants who do not respond to the initial treatment may be offered a second psilocybin-assisted therapy cycle in accordance with protocol defined criteria.
Participants will complete psychological assessments and health evaluations, including ECGs, blood and urine tests, and mental health questionnaires. The study also includes therapy sessions before and after the medication appointment, based on Acceptance and Commitment Therapy (ACT) principles, designed to help participants prepare for and integrate their experience.
Visits will take place during clinic business hours (Monday to Friday, 9am–5pm). The study team will provide full details on procedures, expectations, and potential risks or benefits.
- 1
Enquiry & phone call
We call to explain the study and answer your questions.
- 2
Screening visit
Meet the team and have health checks to confirm eligibility.
- 3
Study visits
Regular visits with expert care and health monitoring.
- 4
Final visit & follow-up
A wrap-up check and a thank-you for helping research.
Still have questions?
Our team is happy to talk it through. Call 1300 742 326.
Frequently asked questions
A clinical trial is a research study involving volunteers that helps researchers evaluate new treatments, medications, medical devices or approaches to healthcare. Clinical trials help determine whether these interventions are safe, effective and appropriate for wider use.
Clinical trials help advance healthcare by showing how treatments work, identifying possible side effects and exploring new ways to prevent, diagnose and manage medical conditions. By taking part, volunteers contribute to knowledge that may benefit people in the future.
Each trial has its own eligibility criteria, which may relate to your age, medical history, health conditions or current medications. Some studies are for people with a specific condition, while others involve healthy volunteers. Our research team can help you understand whether a study may be suitable.
Participant safety and wellbeing are central to clinical research. In Australia, trials must meet strict ethical and regulatory requirements and are reviewed by a Human Research Ethics Committee (HREC). Participants are monitored throughout the study.
All clinical trials involve some uncertainty and level of risk. Before you decide, the research team will explain the known and potential risks, possible benefits and available alternatives.