Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06656702

Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Led by Johns Hopkins University · Updated on 2026-01-12

24

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.

CONDITIONS

Official Title

Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years and older
  • Diagnosis of ALS meeting El Escorial criteria for possible, probable, laboratory supported probable, or definite ALS
  • Pulmonary forced vital capacity (FVC) greater than 60%
  • Ability to swallow tablets by mouth (feeding tube use for psilocybin administration not allowed)
  • Clinically significant depressive symptoms with Assessment of Depression Inventory (ADI)-12 score above 22
Not Eligible

You will not qualify if you...

  • Severe speech impairments including nonverbal status or reliance on assisted speech devices or writing/texting for communication
  • Unable to consent for themselves
  • Presence of tracheostomy or use of continuous positive airway pressure (CPAP) or BiPAP
  • Known clinical evidence of frontotemporal dementia
  • Cardiovascular conditions such as corrected QT interval (QTc) over 450 msec, uncontrolled hypertension, resting heart rate over 90 bpm, angina, significant ECG abnormalities, recent transient ischemic attack (TIA), stroke, or peripheral/pulmonary vascular disease
  • History of epilepsy with seizures
  • Renal disease with creatinine clearance below 40 ml/min
  • Insulin-dependent diabetes or history of hypoglycemia if on oral hypoglycemic agents
  • Females who are pregnant, nursing, or not using effective birth control methods
  • Regular use of medications that interact with psilocybin including certain atypical and tricyclic antidepressants and monoamine oxidase inhibitors
  • Use of Nuedexta, efavirenz, acetaldehyde dehydrogenase inhibitors, alcohol dehydrogenase inhibitors, or certain UGT1A9 or UGT1A10 inhibitors
  • Current or past diagnosis of schizophrenia, psychotic disorder (except if substance-induced or medical condition related), or bipolar I disorder
  • First-degree relative with schizophrenia, psychotic disorder (except if substance-induced or medical condition related), or bipolar I disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

B

Betsy Mosmiller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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