Psilocybin in Chronic Low Back Pain and Depression
Eligible age
21–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 21 to 80 years old
- ✓ Have given written informed consent
- ✓ Report low back pain as ongoing problem ≥ 3 months and any low back pain on at least half of the days over the past 6 months (consistent with NIH Consensus Recommendations for defining CLBP; other chronic pain problems can be present, but CLBP must be reported as primary)
- ✓ Report at least moderate depression symptoms Grid-Hamilton Depression Rating Scale (GRID-HAMD) ≥ 17
- ✓ Fluent in English
- ✓ At least high school level of education
- ✓ Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session
- ✓ Women who are of childbearing potential and sexually active who are not practicing an effective means of birth control must agree to practice an effective means of birth control throughout the duration of the study
You may not qualify if…
- ✕ Lifetime history of serious psychiatric (other than depression) or neurological disorders, including bipolar disorder, psychosis, or seizure disorder
- ✕ History (past 2 years) of severe substance use disorder or current (past six months) substance use disorder of moderate severity
- ✕ Clinically significant suicidal ideation (e.g. with strong intent or means) within past 6 months or history (past 5 years) of suicide attempt
- ✕ Medical condition incompatible with psilocybin administration (e.g., cardiovascular)
- ✕ On unstable/changing dose of opioid, benzodiazepine or other psychoactive or pain medication within 4 weeks prior to enrollment and/or unable to abstain from medication on drug administration day
- ✕ Current use/positive toxicology for illicit drugs or positive breath alcohol test at screening and prior to each drug administration session.
- ✕ Clinically significant transaminitis- aspertate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times normal value).
- ✕ Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing;
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT06355414 · last updated 2025-10-14