Research Study on the Effects of Psilocybin in Adults with Amyotrophic Lateral Sclerosis (ALS)

What is the Purpose of the Study?
To understand whether psilocybin (a naturally occurring psychedelic substance found in some mushrooms), can help improve symptoms of sadness, depression, quality of life, hopelessness, and function in adults with ALS.

What Do You to Do?
Over approximately 8 months, you will have about 15 meetings with the research team. Participants will have two, in-person, monitored, psilocybin dosing sessions with weekly counseling sessions with trained staff over an 8-week period. Symptoms (mentioned above) will be monitored at follow up visits (in-person or remotely) at 1, 3 and 6 months, after the second dosing session. Procedures include initial physical and neurological examinations, questionnaires assessing your mood, quality of life, feelings of hopelessness, and function, blood and urine collections. Care partners will also be asked to complete questionnaires.

You May Be Eligible if You...

• Have been diagnosed with ALS

• Are at least 18 years old

• Have feelings of despair and/or sadness

• Have a care partner willing to help you during the study

• Are able to swallow pills

* There are additional eligibility criteria

Participants will be compensated up to $730 for completion of all steps.

To Learn More About This Study:
Apply at the link below or contact Betsy Mosmiller emosmil1@jhmi.edu / 410-502-0495

Principal Investigators: Ambereen K., Mehta, MD, MPH and Albert Garcia-Romeu, Ph.D.
Protocol: IRB00408938