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Magic mushroom compound tested for Long-Term grief

NCT ID NCT06724289

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial at the University of Virginia is testing whether psilocybin (the active ingredient in magic mushrooms) can help people with prolonged grief disorder. Twelve adults aged 18-65 with complicated grief will receive a single 25 mg dose of psilocybin along with therapy. The main goal is to see if such a study is feasible, while also tracking changes in grief symptoms and brain activity using fMRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin
What this could lead to
If this early trial shows promise, it could point toward a new therapy option for people struggling with prolonged grief.
What could go wrong
This is a very small, early-phase study with only 12 people, so results may not apply broadly. It focuses on feasibility, not proof of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Score of greater than 25 on the Inventory of Complicated Grief * Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session * People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective. * Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9. * Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and/or bupropion (\< 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study * Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen * Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days * Agree not to take any PRN medications on the mornings of drug sessions * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration * Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals * Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours * Willingness and ability to follow study protocol as directed by research staff * Willing and able to attend all sessions in the study and complete follow up assessments * Fluent in English * Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task. Exclusion Criteria: General medical exclusion criteria: * 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. * History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases * Type 1 diabetes * BMI \<18 * Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs. Bupropion dosage must be \< 300 mg in order to be included * Nicotine dependence that would be incompatible with remaining in study area for the entirety of the visit * Prescribed or illicit use of benzodiazepines or opioids within 4 weeks prior to screening * Baseline blood pressure greater than 139/79 (after repeat measures) unless stable with medication as determined by PI or PI designate * Taking any muscle relaxers, antihistamines, or other medications known to cause lethargy or impair cognitive ability within one day prior to psilocybin session * Serious medical comorbidity requiring medical intervention or close supervision * History of claustrophobia * Any court mandated or legal restrictions that would impair the participant from attending all visits * Inability to follow and comply with all study procedures * Deemed unable to meaningfully or safely participate in the study * Any legal judgement toward subject determined to interfere with study attendance or jeopardize compliance with study protocol determined by PI or designate * Individuals who are unable to undergo MRI as determined by MRI pre-screening. General psychiatric exclusion criteria: * Score of less than 25 on the Inventory of Complicated Grief * Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis * Clinically significant suicidal ideation (e.g., with strong intent or means) within past 6 months or lifetime history of suicide attempt based on the MINI, Patient Health Questionnaire-9 or Columbia-Suicide Severity Scale. At any point during the study, a participant may be withdrawn from the study for concerns of suicidality and provided follow-up care by our team or a referral to care if needed. * Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I disorder * Current or previous history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco, caffeine, and cannabis) * Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day * Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder

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Conditions

The condition(s) this trial relates to.

Prolonged Grief Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.