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 (PEX010) 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.
You may be eligible if:
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 (PEX010), will be taken as part of a single dosing session. This is a blinded, comparator-controlled study: 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 two capsules to ensure consistency in the dosing experience.
Participants will also 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.
Participants will be reimbursed for their time and commitment to the study.