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 the 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.

See if you qualify

The information you provide will be kept confidential.