Actively Recruiting
Psilocybin for Prolonged Grief Disorder
Led by University of Virginia · Updated on 2026-03-03
12
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
T
Tiny Blue Dot Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Psilocybin for Prolonged Grief Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 years old up to and including 65 years of age
- Negative urine drug screen results for illicit drugs at screening and before drug administration
- Consent to all study procedures
- Existing diagnosis of Prolonged Grief Disorder or determined complicated grief based on DSM V criteria
- Score greater than 25 on the Inventory of Complicated Grief
- Agree to abstain from psychoactive drugs the day before and day of drug administration
- Sexually active people of childbearing potential must use highly effective birth control throughout the study
- Judged to be at low risk for suicidality by clinical assessment
- Stable concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, or bupropion (less than 300 mg) allowed if stable for at least two months
- Medically stable based on interview, questionnaire, physical exam, ECG, urine beta-HCG, and toxicology screen
- Agree to consume usual caffeine amount or abstain if not routine on drug session days
- Agree not to take PRN medications on drug session mornings
- Agree to avoid sildenafil, tadalafil, or similar medications within 72 hours of drug administration
- Refrain from nonprescription medications, supplements, or herbal supplements for one week before each drug session except approved exceptions
- Willing and able to remain in observation room up to 10 hours during visits
- Willing and able to follow study protocol and attend all sessions and follow-ups
- Fluent in English
- Able to provide one photo of a deceased loved one and one photo of a living loved one for grief elicitation
You will not qualify if you...
- Previous frequent or unsafe use of psychedelic drugs as determined by study staff
- Pregnant, nursing, or planning pregnancy during the study
- Sexually active people of childbearing potential not using effective birth control
- Cardiovascular conditions including coronary artery disease, stroke, angina, clinically significant ECG abnormalities, prolonged QTc interval, heart valve issues, or recent TIA
- History of neurological disorders such as head trauma with deficits, seizures, cerebrovascular disease, epilepsy, or neurodegenerative diseases
- Type 1 diabetes
- Body mass index less than 18
- Regular use of antidepressants other than SSRIs, SNRIs, or bupropion (dose limits apply), or other serotonergic medications including MAOIs
- Nicotine dependence incompatible with study requirements
- Benzodiazepine or opioid use within 4 weeks prior to screening
- Uncontrolled blood pressure above 139/79 unless stable with medication
- Use of muscle relaxers, antihistamines, or cognitive-impairing medications within one day before psilocybin session
- Serious medical conditions requiring intervention or close supervision
- History of claustrophobia
- Legal restrictions preventing full study participation
- Inability to comply with study procedures
- Deemed unable to safely participate by study staff
- Legal judgments interfering with attendance or compliance
- Inability to undergo MRI scanning
- Score less than 25 on Inventory of Complicated Grief
- Severe psychiatric disorders or serious psychiatric or neurological history, including bipolar disorder or active psychosis
- Clinically significant suicidal ideation or past suicide attempts
- Current or past diagnosis of schizophrenia spectrum, other psychotic disorders, or bipolar I disorder
- Recent moderate or severe alcohol or drug use disorder (excluding tobacco, caffeine, cannabis)
- Nicotine dependence incompatible with remaining nicotine-free during sessions
- First-degree relative with schizophrenia, psychotic disorders, or bipolar I disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
F
Fatma Wise, PhD
CONTACT
M
Madison Focht
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here