Exploring PTSD one step at a time.

A PTSD clinical research study for a different type of psychedelic treatment is now enrolling.

About the Redefine Study

The Redefine Study is testing an investigational treatment to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team.

The investigational treatment being studied is a synthetic formulation of psilocybin. The investigational treatment is a pill that is taken by mouth.

As part of the clinical research study, participants will take the investigational treatment twice, with each dose given about 4 weeks apart at the study site. Participants will be in a comfortable room with dim lighting and relaxing music while taking the investigational treatment during clinic visits. Much of the day will be spent resting or lying down while being closely monitored by the study team. The study team will check your blood pressure and overall well-being throughout the day to help ensure your safety and will confirm when it is safe for you to leave the study site. For most participants, this visit will last 7 to 8 hours.

As part of participating, you will be provided with educational materials about the investigational treatment and will meet with the trained study team to go over any questions you have. These sessions may also include practicing grounding and calming techniques.

The study will last up to 62 weeks (about 15 months). Part A will include 2 dosing sessions, 4 weeks apart, during the first 12 weeks. After 12 weeks you will enter Part B of the study. The study team will determine if you are eligible for a third dose of the investigational treatment. There will be up to 30 appointments during the study—some of these will be in person and some will be remote.

How to Qualify

You may be able to participate in this study if you:

Are 18 years or older
Were diagnosed with PTSD at least 6 months ago
Experienced the traumatic event that led to PTSD within the past 12 years
Were aged 16 years or older when the traumatic event that led to PTSD occurred
Have NOT experienced a new traumatic event in the last 3 months
Have NOT been diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions

This is not a complete list of requirements. The study doctor will review all the requirements with you.

Why Participate?

If you qualify and decide to participate, you will receive:

All study-related care and the investigational treatment at no cost
The opportunity to potentially help researchers learn more about PTSD
Assistance with study-related travel expenses, as needed

Your safety while participating in Redefine Study is our highest priority. If you have any questions or concerns, the study team is available to help you.

Your participation is always voluntary. You are free to withdraw from the clinical research study at any time and for any reason. Your privacy will be maintained throughout.

About PTSD

Post-traumatic stress disorder (PTSD) can occur after experiencing or witnessing a traumatic event.

Symptoms may include:

Intrusive memories or nightmares
Avoiding reminders of the trauma
Feeling constantly tense, watchful, or on edge
Difficulty sleeping, concentrating, or managing emotions

By participating, you may help researchers learn more about PTSD and PTSD investigational treatments for the future.

Your participation may last up to about 15 months. There will be up to 30 appointments, both in-person and remote, during the study. Participants may receive 2 doses of the investigational treatment during the first 12 weeks. After 12 weeks you will enter Part B of the study. The study team will determine if you are eligible for a third dose of the investigational treatment.

During study visits, you will have medical and psychological assessments that will include checking your vital signs (blood pressure, heart rate, temperature), ECGs, blood and urine samples, a review of your medications, and answering questionnaires about your PTSD symptoms and general health. Your safety while participating in the Redefine Study is our highest priority. If you have any questions or concerns, the study team is available to help you.

On dosing days, you will take 1 capsule of the investigational treatment at the study site with a glass of water (after an optional light breakfast at least 2 hours beforehand). Each dosing session lasts about 7 to 8 hours. During the session, you may experience a variety of physical or emotional sensations. Some may feel neutral or pleasant, while others may feel uncomfortable. Trained study team members will be monitoring your safety at all times. The study team will also assess you at the end of the session to make sure it is safe for you to leave the study site.

Yes, participation in clinical research studies is always voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, and without any effect on your future medical care. If you withdraw from the study early, talk to the study doctor about leaving so you can schedule a final evaluation.

About Clinical Research Studies

A clinical research study, also called a clinical trial, is conducted to learn whether an investigational treatment is safe and effective for use in people with the medical condition being studied.

Clinical research studies must follow strict scientific standards to help ensure the safety of the participants while researchers learn more about the investigational treatment.

An investigational treatment is a substance that is being tested in clinical research studies. An IRB (Institutional Review Board) or ethics committee has reviewed the clinical research study for testing in people, and the investigational treatment may or may not be approved for treatment for the condition being studied.