Actively Recruiting

Phase 1
Age: 21Years +
All Genders
NCT06989957

Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)

Led by Johns Hopkins University · Updated on 2025-10-01

40

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

G

Gracias Family Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet

CONDITIONS

Official Title

Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 21 years old or older
  • Be a military Veteran
  • Provide written informed consent
  • Able to swallow pills
  • Have a confirmed DSM-5 diagnosis of Post-traumatic Stress Disorder with symptoms lasting 6 months or longer
  • Have a baseline CAPS-5 score of 28 or higher
  • Be judged by study clinicians to be at low acute risk for suicidality
  • Concurrent psychotherapy allowed if stable in type and frequency for at least two months prior to screening and expected to remain stable during the study
  • Be medically stable based on interview, questionnaire, physical exam, ECG, and routine blood and urine tests
  • Agree to consume about the same amount of caffeine on drug session mornings as usual (or avoid caffeine if not usually consumed)
  • Agree to refrain from psychoactive drugs and alcohol within 24 hours of drug administration, except caffeine and nicotine
  • Agree to avoid caffeine and nicotine within 2 hours before dosing sessions
  • Agree not to take as-needed medications on drug session mornings without treatment team approval
  • Agree not to take sildenafil, tadalafil, or similar medications within 72 hours of drug administration
  • Agree to stop taking 5HT2A antagonist medications at least 5 half-lives before dosing
  • Agree to refrain from nonprescription medications, supplements, or herbal products for one week before each drug session unless approved by investigators
  • Have no lifetime use of serotonin 2A receptor agonist hallucinogens or MDMA above a microdose level
  • Have at least a high school education or equivalent
  • Weigh between 40 kg and 120 kg
  • Provide a contact person who can be reached if participant becomes unreachable or suicidal
  • Agree to be released into custody of a support person or accompanied home after drug sessions
  • May have stable Type 2 Diabetes Mellitus with cardiovascular disease ruled out and approval by Medical Monitor
  • May have hypothyroidism if on stable thyroid replacement
  • May have history or current glaucoma with ophthalmologist approval
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of schizophrenia spectrum, other psychotic disorders, or Bipolar I or II Disorder
  • Moderate or severe alcohol or drug use disorder within past year (excluding tobacco, caffeine, cannabis)
  • Current or past diagnosis of Borderline Personality Disorder
  • Significant suicidal ideation within past 6 months (C-SSRS > 3)
  • First-degree relative with schizophrenia, psychotic disorders, or Bipolar I
  • Nicotine dependence incompatible with nicotine abstinence on dosing days
  • Medical conditions unsafe for MDMA or psilocybin (e.g., cardiovascular issues, drug-induced hyperthermia, hyponatremia)
  • Daily use of medications affecting serotonin or liver enzyme metabolism
  • Use of specific medications like efavirenz, disulfiram, and others listed
  • Unstable or changing dose of opioids, benzodiazepines, psychoactive or pain medications within 4 weeks prior to enrollment
  • Illicit drug use or positive alcohol test at screening or before drug sessions
  • Lifetime use of psychedelic drugs above microdose level
  • Significant liver enzyme elevations
  • Women who are pregnant or nursing
  • Women of childbearing potential must use highly effective birth control during study
  • Cardiovascular diseases including coronary artery disease, stroke, angina, uncontrolled hypertension, significant ECG abnormalities, prolonged QTc, heart valve issues, or recent TIA
  • History of seizures or epilepsy
  • Type 1 diabetes
  • BMI below 18
  • Likely re-exposure to trauma, lack of social support or stable living situation
  • Electroconvulsive Therapy within 12 weeks prior to enrollment
  • Medical conditions increasing risk with sympathomimetic drugs
  • Symptomatic liver disease or significant liver enzyme elevations
  • Other mild stable chronic conditions allowed if approved by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States, 21224

Actively Recruiting

Loading map...

Research Team

C

Chloe Ford, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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