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Psychedelic

Psilocybin for Prolonged Grief Disorder

Phase < 1
Waitlist Available
Led By Jennifer K Penberthy, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 21 years old up to and including 65 years of age
Have an existing diagnosis of Prolonged Grief Disorder
Must not have
History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases
Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from administration of study drug to 6-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to investigate if it is possible to conduct a study on how psilocybin impacts individuals with prolonged grief disorder."

Who is the study for?
Adults aged 21-65 with Prolonged Grief Disorder, who speak English, can avoid psychoactive drugs and caffeine before sessions, use effective birth control if applicable, have low suicide risk, are stable on certain antidepressants for two months prior to the trial, and have limited hallucinogen use. Excludes pregnant or nursing individuals, those with significant medical conditions or psychiatric disorders like schizophrenia or bipolar I disorder.
What is being tested?
The study is testing a single dose of Psilocybin (25 mg) to see if it's feasible as a treatment for Prolonged Grief Disorder. Participants will be observed in a controlled setting during the drug session which lasts up to 10 hours.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, increased heart rate and blood pressure changes; psychological effects such as anxiety or distressing visions; mood changes; and potential exacerbation of pre-existing mental health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.
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I have been diagnosed with Prolonged Grief Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious head injury, seizures, or neurological diseases.
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I have not had a severe psychiatric disorder other than depression in the last 6 months.
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I can follow all study procedures.
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I do not have serious heart conditions or uncontrolled high blood pressure.
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I have or had schizophrenia, bipolar I, or a similar psychotic disorder.
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I have Type 1 diabetes.
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I haven't taken muscle relaxers, antihistamines, or similar drugs that cause drowsiness within a day before a psilocybin session.
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I have not had serious thoughts of suicide or attempted suicide in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from administration of study drug to 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from administration of study drug to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aim 1
Secondary study objectives
Aim 2

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label, single arm trialExperimental Treatment1 Intervention
25 mg psilocybin administered to each participant

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,434 Total Patients Enrolled
Jennifer K Penberthy, PhDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
9 Total Patients Enrolled
~8 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
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