Psilocybin Assisted Therapy for Post-Traumatic Stress Disorder

Introduction and Rationale for Study

Post-traumatic stress disorder (PTSD) is a debilitating and serious health condition that impacts an individual’s relationships, cognitive and psychosocial functioning, and overall quality of life. Although numerous therapeutic approaches including the use of antidepressant medications exist for addressing PTSD, current treatments are insufficient.

Due to the success of MDMA-assisted psychotherapy (an FDA designated breakthrough therapy) for PTSD and past trial outcomes of psilocybin for major depressive disorder (MDD), research is warranted to investigate the potential of psilocybin-assisted therapy for those with PTSD.

Purpose and Description

The purpose of COMP 201 is to investigate the safety, tolerability, and feasibility of psilocybin in participants with post-traumatic stress disorder.

The study involves the following in-person activities between a 15 – 18 week period:

  • 1 screening visit
  • 3 or more preparation visits
  • Drug administration
  • 3 Integration sessions
  • 4 additional follow up visits
  • A variety of medical and psychiatric assessments are performed throughout the study, including blood draws.

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. Eligible participants are given a small stipend for each visit. Reasonable travel expenses may be reimbursed
  • All visits take place in person at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
  • This is an open-label study, meaning each eligible participant will receive one dose of 25mg psilocybin.
  • Psilocybin will be administered in a safe setting with constant support from trained and experienced therapists. The support includes careful preparation before the experience and processing after the experience. Psychedelic effects are typically temporary, and safety is continually monitored.
  • Eligible participants will taper off of, or discontinue from, all antidepressants as part of their participation in the study. This plan is created with study physician approval and participant safety is monitored. Participants MUST NOT discontinue ANY medication without the physician approval. If necessary, the study physician will consult with patients’ providers.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must be willing to use a highly effective method of birth control for the entire duration of the study.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

Potential benefit of participation

Psilocybin has the potential to mitigate symptoms associated with PTSD.To inquire about participation in the COMP 201 Study, apply below:

For more information about the study: