Participating in a Clinical Trial:

Advancing the Science of Mental Health, Together

Living with persistent mental health challenges shouldn’t mean giving up hope. At Psychedelic Science Institute (PSI), we understand that you may have tried many therapies to find relief. If traditional approaches or the current “standard of care” have not been effective, participating in a clinical trial can offer a structured, science-backed path forward. As psychedelic medicines are neuroplastogens that may induce structural and functional brain changes to positively impact behavior and brain health, exploring their therapeutic potential is warranted.

Your Contribution Matters

By participating in a clinical trial at PSI, you acknowledge that there may be better treatment options for your condition worth trying. These trials aim to define the potential benefits and risks of a given psychedelic-assisted therapy in a specific patient group. If eligible, your participation will directly contribute to the rigorous research needed to advance psychedelic medicines like psilocybin, LSD, 5-MeO-DMT, DMT, and MDMA towards FDA approval.

Your involvement will also work towards expanding access to these therapies, including to underserved and under-represented communities, like BIPOC and LGBTQIA+ communities.

What to Expect:

Your Journey as a Partner in Research

When you participate in a clinical trial at PSI, you’re considered a valued partner in advancing scientific understanding of a specific psychedelic compound. Our process is structured, compassionate, and prioritizes your safety.

Comprehensive Assessment & Consent: Your journey begins with assessing your eligibility for a specific clinical trial including inclusion and exclusion criteria and undergoing a comprehensive psychological and medical evaluation. We explain every step plainly, and without pressure, ensuring full understanding before you decide anything. You are in control, and can pause, opt out, or ask questions at any point.
‍The "Set and Setting" Model: Psychedelic-assisted therapy in trials utilizes the "set and setting" model, where your mindset ("set") and the supportive environment ("setting") are carefully optimized. This includes:
- Preparatory Counseling: Sessions designed to help you prepare for the psychedelic medicine session and maximize its benefit.
- Medically Supervised Dosing Sessions: These sessions take place in our specialized "trip rooms" designed for a safe and therapeutic journey. You will be accompanied by experienced psychedelic guides and monitored by a physician for safety.
- Integration Counseling: After the dosing session, you will engage in a series of integration therapy sessions to help you process your experiences and apply insights to make meaningful changes in your life.‍
Expert Team & Safety: Your care is delivered by a highly trained, compassionate, and multidisciplinary team of licensed psychiatrists, psychotherapists, and neuroscientists, with certifications in trauma-informed and culturally responsive care. We adhere to clear medical protocols and continuous supervision, prioritizing your safety and well-being. We provide clear documentation, updates, and optional debriefs for continuity of care.

Active & Completed Clinical Trials

PSI/TRIP is actively involved in clinical research across a range of psychedelic medicines and mental health conditions. While ketamine is currently the only FDA-approved drug with psychedelic properties available for off-label use outside clinical trials, we are at the forefront of evaluating multiple psychedelic compounds for specific indications. .