Actively Recruiting
Psilocybin-Assisted Therapy for Prolonged Grief Disorder
Led by University of Virginia · Updated on 2026-03-03
12
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating the effects of a single 25 mg dose of psilocybin on symptoms of Prolonged Grief Disorder PGD. This early phase 1 trial aims to assess whether psilocybin can reduce grief and trauma symptoms by facilitating mystical or spiritual experiences. Brain function changes related to grief will be studied using functional magnetic resonance imaging fMRI before and after treatment. Participants will receive a single 25 mg dose of psilocybin in an open-label, single arm trial. Two fMRI scans will be conducted, one 1 to 14 days before and another 1 to 14 days after psilocybin administration, where participants view images to help researchers understand brain activity changes. The study includes preparation and follow-up visits to monitor effects. During the study, participants will attend multiple visits including screening, preparation, treatment, and follow-up assessments up to six months. They will complete various questionnaires measuring grief, trauma, mystical experience, psychological flexibility, and other related symptoms. Safety will be monitored throughout, and researchers will track recruitment and dropout rates as primary outcomes over the enrollment and six-month follow-up periods.
CONDITIONS
Brief 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 each drug session
- Consent to all study procedures
- Existing diagnosis of Prolonged Grief Disorder or Complicated Grief Disorder based on DSM V criteria
- Score greater than 25 on the Inventory of Complicated Grief
- Agree to avoid 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 at low risk for suicidality by study clinicians
- Stable psychotherapy or pharmacotherapy with SSRIs, SNRIs, or bupropion (less than 300 mg) allowed if stable for two months prior
- Medically stable as determined by interview, exam, ECG, urine tests, and toxicology screen
- Agree to consume usual caffeine amount or none on drug session mornings
- Agree not to take PRN medications on drug session mornings
- Agree to avoid sildenafil, tadalafil, or similar drugs within 72 hours of drug administration
- Refrain from nonprescription medications, supplements, or herbal supplements for one week before each drug session unless approved
- Willing and able to stay in observation room for up to 10 hours during visits
- Able to follow study protocol and attend all sessions and follow-up assessments
- Fluent in English
- Ability to provide one photo of a deceased loved one and one photo of a living loved one for grief tasks
You will not qualify if you...
- Previous use of psychedelic drugs may exclude depending on safety assessment
- Pregnant, nursing, or planning pregnancy at screening or drug sessions
- Sexually active people of childbearing potential not using effective birth control
- Cardiovascular conditions including coronary artery disease, stroke, angina, significant ECG abnormalities, prolonged QTc, heart valve issues, or recent TIA
- History of neurological disorders such as 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 over 300 mg
- Nicotine dependence incompatible with study requirements
- Use of benzodiazepines or opioids within 4 weeks prior to screening
- Blood pressure over 139/79 unless stable with medication
- Use of muscle relaxers, antihistamines, or other cognitive-impairing medications before sessions
- Serious medical comorbidities requiring close supervision
- History of claustrophobia
- Legal restrictions impairing attendance
- Inability to comply with study procedures
- Unsafe or unable to participate as judged by investigators
- Legal judgments interfering with attendance or compliance
- Inability to undergo MRI
- Severe psychiatric disorders except depression, recent or lifetime serious psychiatric or neurological disorders
- Significant suicidal ideation or history of suicide attempts
- History of schizophrenia spectrum or bipolar I disorder
- Recent moderate or severe alcohol or drug use disorder except tobacco, caffeine, or cannabis
- Nicotine dependence incompatible with 8-10 hours nicotine freedom on session days
- First degree relative with schizophrenia, psychotic disorders, or bipolar I disorder
Research Team
F
Fatma Wise, PhD
M
Madison Focht
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