Psilocybin in Chronic Low Back Pain and Depression
Double-blind, active-control randomised study (n=40) comparing a single 25 mg psilocybin dose to 40 mg methylphenidate in people with chronic low back pain and depression to assess safety, feasibility and effects on pain-related mechanisms.
Details
Randomized, triple-masked, parallel-group trial comparing a single fixed 25 mg oral psilocybin dose to a single fixed 40 mg oral methylphenidate dose in participants with chronic low back pain and comorbid depression. Study assessments occur at screening, acutely before and after the drug session, multiple times per day via a survey application, and at follow-up visits up to one month.
Primary objectives are feasibility, safety and acceptability, and effects on positive/negative affect and pain catastrophizing; secondary objectives include durability at one month and moment-to-moment associations among affect, pain, and function.