NCT07306364

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.

Detailed description

Preclinical and human studies suggest that psilocybin can temporarily disrupt rigid, maladaptive patterns of brain activity and promote longer-lasting changes in how the brain processes internal sensations. People with chronic pain who have used psilocybin qualitatively describe feeling more aware of their bodies, able to reinterpret pain sensations, and less distressed and disabled by their pain. Building on these mechanistic insights, this randomized, double-blind, placebo-controlled trial will evaluate a single dose of low- (10 mg), moderate-dose (25 mg), or placebo (niacin) administered prior to a standardized course of physical therapy (PT) in adults with chronic low back pain (CLBP). Participants in both treatment groups will receive a course of PT that is consistent with what would be delivered outside of involvement in the research study. That is, the study is evaluating psilocybin as an adjunct to PT delivered in a community outpatient PT clinic. By testing whether psilocybin-induced recalibration of brain networks can enhance engagement with and outcomes of PT, this study aims to establish a novel, non-opioid integrative strategy to relieve CLBP and restore functional recovery.

Conditions

• Chronic Low Back Pain (CLBP)
• Physical Therapy
• Psilocybin

Interventions

Type	Name	Description
DRUG	Psilocybin 10 mg	Two 5 mg psilocybin capsuels will be administered to participants randomized into the low-dose psilocybin group.
DRUG	Psilocybin 25 mg	One 25 mg psilocybin capsuel and one 100 mg niacin (placebo) capsuel will be administered to participants radomized into the moderate-dose psilocybin group.
DRUG	Niacin 100 mg	Two 100 mg niacin capsuels will be adminstered to participants randomized to the placebo group.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study