Psilocybin in Chronic Low Back Pain and Depression

This double-blind, active control study (n=40) investigates the effects of psilocybin (25mg) on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).

Participants aged between 21 to 65 years old, reporting ongoing low back pain for at least three months and moderate depression symptoms, will be recruited. They will receive either a single high dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose).

Assessments will include pain, depressive symptoms, and general questionnaires regarding experiences during experimental sessions. The primary objectives are to evaluate the feasibility, safety, and acceptability of psilocybin for CLBP+D, as well as its effects on self-reported positive affect, negative affect, and pain catastrophizing. Secondary objectives include assessing the durability effects of psilocybin on these measures at a 1-month follow-up and investigating dynamic associations between affective measures, pain, and function on a moment-to-moment basis.

This study is an interventional, randomised, double-blind, active control trial, conducted by Johns Hopkins University in Maryland, United States. It commenced on April 22, 2024, and is estimated to conclude by August 30, 2026. The study aims to recruit 40 participants and is part of Phase I clinical trials.

Topic Depression Pain Safety
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 22 April 2024
End date 30 August 2026
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 21- 65
Therapy No

Trial Details

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.

Trial Number NCT06355414

Sponsors & Collaborators

Johns Hopkins University
Johns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.

Data attribution

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