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Phase 2Not yet recruiting

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

Sponsor
Yale University (Academic or other)
Enrollment
48 planned
Conditions
Chronic Low Back Pain (CLBP); Physical Therapy; Psilocybin
Interventions
Psilocybin 10 mg; Psilocybin 25 mg; Niacin 100 mg
Ages
adults, older adults
Registry
NCT07306364

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change in interoceptive awareness as measured by the Multidimensional Assessment of Interoceptive Awareness-2 from 4 weeks post-dose to 8 weeks post dose
  • Change in Pain, Enjoyment, and General Activity (PEG) total score at 8 weeks post dose
  • Change in functional disability measured by the Oswestry Disability Index (ODI) from baseline to 8 weeks post-dose.

History

  1. Primary completion expected

  2. Expected to start

  3. Last registry update

  4. Registered