Magic mushroom compound tested for PTSD relief in small study

NCT ID NCT06407635

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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-stage study tests whether psilocybin (the active ingredient in magic mushrooms) can safely help adults with long-term PTSD who are already taking antidepressants. Twenty participants will receive psilocybin, and some will also get trauma-focused talk therapy. The goal is to see if psilocybin reduces PTSD symptoms and improves well-being, while checking for side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Started

Jun 2024

Expected to finish

May 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

21 to 75 years

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: * Be at least 21 years old * Have given written informed consent * Have a confirmed DSM-5 diagnosis of Post-Traumatic Stress Disorder with symptom duration \>= 6 months * Have a baseline CAPS-5 score of \>=35 * Currently taking a serotonin reuptake inhibitor (SSRI or SNRI) at a stable dose for at least 3 months. * Be judged by study team clinicians to be at low acute risk for suicidality * Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes 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, he/she must agree not to do so on session days. * Agree to refrain from using alcohol, anxiolytics, stimulants, sedatives or hypnotics, opioids, dissociatives, cannabinoids, or other unapproved substances within 24 hours of psilocybin administration. Caffeine and nicotine are exceptions. * Agree not to take any as needed (PRN) medications on the mornings of drug sessions * Agree to stop taking 5HT2A antagonist medications at least 5 half-lives before psilocybin dosing. * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration. * Have no classic psychedelic use in the past five years. * Have at least a high school level of education or equivalent (e.g. GED). * Weigh at least 40kg. * (for female participants) Agree to use highly effective birth control measure within two weeks before and after dosing sessions. * (for male participants) Agree to use contraception and refrain from sperm donation two weeks before and after dosing sessions, as the reproductive safety for psilocybin is not yet established. Exclusion Criteria: General medical exclusion criteria: * Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child- bearing potential and sexually active who are not practicing an effective means of birth control. * Cardiovascular conditions: coronary artery disease, stroke, angina, hypertension with resting blood pressure systolic \>139 or diastolic \>89, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (QTc) interval (i.e., QTc \> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year * Family history of Torsades de Pointes and sudden cardiac death * Epilepsy with history of seizures * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia * Currently taking a Monoamine Oxidase Inhibitor Psychiatric Exclusion Criteria: * Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder * Current or history within one year of meeting DSM-5 criteria for a severe alcohol, tobacco, or other drug use disorder (excluding caffeine) * Current or history within one year of meeting DSM-5 criteria for Borderline Personality Disorder. * Have a first degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I. * Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * History of a medically significant suicide attempt * Unwilling or unable to pause concurrent psychotherapy during the study. * Determined to be at risk for re-exposure to the index trauma or other significant trauma in daily life.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Johns Hopkins Center for Psychedelic and Consciousness Research

    Baltimore, Maryland, 21224, United States

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