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Psychedelic drug could lift spirits in final years

NCT ID NCT05403086

Symptom relief Sponsor: Charles S. Grob, M.D. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether psilocybin therapy can reduce demoralization in adults with a life expectancy of two years or less. One hundred participants will receive either psilocybin or an active control (ketamine) in a triple-blind design. The goal is to see if this approach safely improves emotional well-being in palliative care.

What this could mean

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

Active substance
psilocybin (a psychedelic drug)
What this could lead to
If it works, this could offer a new way to ease deep distress and improve quality of life for people near the end of life.
What could go wrong
This is a mid-stage trial with only 100 people, so results may not apply to everyone. Psychedelic therapy can cause temporary confusion or emotional discomfort.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Jan 2025

Expected to finish

Dec 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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: General * Provision of signed and dated informed consent form and the capacity to consent to research. * Stated willingness to comply with all study procedures and availability for the duration of the study * Is currently a patient in a study-engaged clinical site * Has a life-threatening illness and a life expectancy of ≤2 years * Has moderate-to-severe demoralization * Ability to take oral medication (capsules and liquid) Exclusion Criteria: General * Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine * Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF) * If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention Neurological * Cognitive impairment sufficient to impede the ability to complete study tasks * History of intracranial hemorrhage * Recent embolic stroke * Recent seizure * Current intracranial mass * Advanced stage of a neurologic disease that elevates risk for psychosis Cardiovascular * Uncontrolled hypertension * Clinically significant cardiac disease Respiratory * Severe pulmonary disease * Supplemental oxygen requirement Gastrointestinal * Current intractable nausea/vomiting/diarrhea * Recent, clinically significant GI bleed * Markedly abnormal liver function tests Endocrine, Renal, and Reproductive * Pregnancy or lactation * Severe renal insufficiency * Unstable insulin-dependent diabetes mellitus Prohibited Medications * Antipsychotics (with exceptions) * Antidepressants (with exceptions) * Dopamine agonists * Drugs known to have adverse interactions with psilocybin or ketamine

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As listed by the trial registrant

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

Demoralization

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • Marin Cancer Care

    RECRUITING

    Greenbrae, California, 94904, United States

  • Sunstone Therapies

    RECRUITING

    Rockville, Maryland, 20850, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of San Francisco

    RECRUITING

    San Francisco, California, 94518, United States

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