REKINDLE: Your Ability to Cope With a Life-Changing Medical Diagnosis

About the Study

The REKINDLE Study is testing an investigational single-dose, short-acting psychedelic medication. Our goal is to see if it can help promote better mental health in people with symptoms of depression and anxiety linked to adjustment disorder due to a serious medical diagnosis.

The moment you receive a cancer or similar diagnosis, time can seem to stand still. Profound feelings of fear, anger, and loss are very common. The emotional toll of facing uncertainty, grappling with loss of control, and preparing for difficult changes can be just as heavy as the physical symptoms. It is important to remember to prioritize your mental health in these situations because these feelings can sometimes become truly overwhelming. When these feelings affect your ability to cope, this is called adjustment disorder.

The study drug is an investigational psychedelic medication that is structurally similar to psilocybin (the active compound in “magic mushrooms”) that may help ease psychiatric symptoms of adjustment disorder.

What the Study Involves

Interested potential study participants will be screened at a study center where they will be assessed to ensure they can participate safely. During the screening process, participants will also meet and get to know their Session Monitors, professionals trained to guide and stay with them during their psychedelic experience.

Participants will receive a single dose of the study medication or a low-dose comparator at the study center and will be monitored in a comfortable environment. Participants will have a 50/50 chance of being assigned to either group (like the flip of a coin). Participants will then be followed for six weeks to evaluate their symptoms and check on their safety.

Including the screening period, dosing visit and the follow-up period, participation in this study will last up to ten weeks. 

• The screening period is up to 28 days 
• The dosing visit is one day
• The follow-up period is 42 days

There is no charge to participate. Participants may be reimbursed for study-related expenses. Please ask the study staff for details. 

To learn more, visit rekindlestudies.com. 

To be eligible to participate, you must be: 

• Between 18 and 80 years old
• Diagnosed with cancer (stages 1-4) or other serious conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), or idiopathic pulmonary fibrosis (IPF)
• Experiencing symptoms of depression and/or anxiety and feeling overwhelmed for at least four weeks

You are not eligible to participate if you: 

• Are not between 18 and 80 years old
• Do not have a diagnoses of cancer (stages 1-4) or other serious conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), or idiopathic pulmonary fibrosis (IPF)
• Are not experiencing symptoms of depression and/or anxiety and feeling overwhelmed for at least four weeks