Clinical Trial for Adults Living with PTSD
This study is evaluating an investigational psilocybin formulation that may help reduce symptoms of Post-Traumatic Stress Disorder (PTSD).
Study overview
This study is evaluating an investigational psilocybin formulation that may help reduce symptoms of Post-Traumatic Stress Disorder (PTSD).
PTSD can affect emotional wellbeing, daily functioning, and quality of life. Researchers are exploring whether this investigational treatment may support improvements in how people process and respond to trauma-related experiences.
The study aims to assess how safe and well-tolerated the treatment is, and whether it may help reduce PTSD symptoms and improve overall wellbeing.
Am I eligible?
You may be eligible if:
- Are 18 years or older
- Meet DSM-5 diagnostic criteria for PTSD
- Have moderate symptom severity and a duration of ≥6 months
- Are able to comply with study visits and procedures
- You are able to commit to the full study duration (approximately 52 weeks)
What taking part involves
If eligible, you will take part in the study for up to approximately 52 weeks, which includes two parts:
- Part A (12 weeks): Includes 12 in-clinic visits, with preparation sessions and two study treatment sessions (approximately 4 weeks apart), along with follow-up visits and assessments.
- Part B (up to 40 weeks): Includes 9 in-clinic visits and 5 phone calls. Participants who complete Part A will continue into this phase to assess longer-term safety, durability of effects, and an additional open-label treatment option.
Throughout the study, you will be supported by trained professionals before, during, and after each treatment session. Researchers will monitor your PTSD symptoms, overall wellbeing, and safety through regular check-ins and assessments.
- 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.