Actively Recruiting

Phase 1
Age: 21Years - 80Years
All Genders
NCT06355414

Psilocybin in Chronic Low Back Pain and Depression

Led by Johns Hopkins University · Updated on 2025-10-14

40

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.

CONDITIONS

Official Title

Psilocybin in Chronic Low Back Pain and Depression

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 80 years
  • Provided written informed consent
  • Have ongoing low back pain for 3 months or more and pain on at least half the days over the past 6 months
  • Moderate or higher depression symptoms with a GRID-Hamilton Depression Rating Scale score of 17 or more
  • Fluent in English
  • At least a high school education level
  • Agree to avoid psychoactive drugs the day before and the day of drug administration
  • Women of childbearing potential must use effective birth control throughout the study
  • Judged to be at low risk for suicidality by study clinicians
  • Stable psychotherapy or pharmacotherapy with SSRIs, SNRIs, and/or bupropion (less than 300 mg) for at least two months before screening
  • Medically stable based on interview, examination, ECG, and lab tests
  • Agree to consume usual caffeine amounts on drug session mornings or abstain if not routine consumer
  • Agree not to take PRN medications on drug session mornings
  • Agree to avoid sildenafil, tadalafil, or similar medications within 72 hours of drug administration
  • Refrain from nonprescription, nutritional, or herbal supplements for one week before each drug session except approved exceptions
  • Limited lifetime hallucinogen use (preferably no use in past 5 years and less than 10 total uses)
Not Eligible

You will not qualify if you...

  • History of serious psychiatric or neurological disorders other than depression (e.g., bipolar disorder, psychosis, seizure disorder)
  • Severe substance use disorder in the past 2 years or moderate substance use disorder in the past 6 months
  • Significant suicidal ideation within past 6 months or suicide attempt within past 5 years
  • Medical conditions incompatible with psilocybin (e.g., cardiovascular problems)
  • Unstable or changing doses of opioids, benzodiazepines, psychoactive or pain medications within 4 weeks prior to enrollment
  • Current use or positive test for illicit drugs or positive breath alcohol test at screening or before drug administration
  • Elevated liver enzymes more than twice the normal value
  • Pregnant or nursing women
  • Women of childbearing potential who do not practice effective birth control
  • Cardiovascular issues such as coronary artery disease, stroke, uncontrolled hypertension, atrial fibrillation, prolonged QTc, heart valve problems, or TIA in past year
  • History of seizures or epilepsy
  • Type 1 diabetes
  • Body mass index less than 18
  • Contraindications for methylphenidate including recent MAOI use, Tourette's syndrome, certain sugar intolerances, glaucoma, hypersensitivity to methylphenidate, severe agitation or anxiety, and motor tics
  • Use of antidepressants other than SSRIs, SNRIs, or low dose bupropion regularly
  • Nicotine dependence incompatible with being nicotine-free for 8-10 hours on psilocybin session day
  • First-degree relative with schizophrenia, psychotic disorders, or bipolar I disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

A

Arozo Azimi, BA

CONTACT

K

Kelcy A Klein, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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