RecruitingPhase 1NCT06355414

Psilocybin in Chronic Low Back Pain and Depression

Psilocybin and Affective Function in Chronic Lower Back Pain Depression


Sponsor

Johns Hopkins University

Enrollment

40 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether psilocybin — the active compound in "magic mushrooms" — can help people who suffer from both chronic low back pain and depression. Researchers believe psilocybin may reset how the brain processes pain and mood, potentially offering relief for both conditions at once. **You may be eligible if...** - You are between 21 and 80 years old - You have had low back pain on most days for at least 6 months - You have at least moderate depression symptoms (score of 17 or higher on a standard scale) - You are fluent in English with at least a high school education - You agree to avoid other mind-altering substances on the day before and day of the study drug sessions - Your current therapy (such as antidepressants or talk therapy) has been stable for at least 2 months **You may NOT be eligible if...** - You are at high risk for suicidal behavior - You have a personal or family history of psychosis (schizophrenia) - You have a history of bipolar disorder with mania or certain other serious mental health conditions - You use illegal stimulants or have a substance use disorder - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Drug administration under supportive conditions

DRUGMethylphenidate

Drug administration under supportive conditions


Locations(1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

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NCT06355414


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