Psilocybin for Prolonged Grief Disorder
ConditionProlonged Grief Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Virginia
About this trial
The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).
Eligibility criteria
Qualifiers
Ages 18 years old up to and including 65 years of age
Negative UDS results for illicit drugs at screening and prior to each drug administration session
Consent to all study procedures
Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria
Disqualifiers
Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.
Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report
People of childbearing potential that are sexually active who are not practicing an effective means of birth control
Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc > 450 msec), heart valve, or TIA in the past year.
Trial design
Treatments tested in this trial
- Psilocybin 25 mg
- Functional Magnetic Resonance Imaging (fMRI)
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Virginia
Lead sponsor
Tiny Blue Dot Foundation
Collaborator
Texas Tech University
Collaborator
Source ClinicalTrials.gov