Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes
Yale University
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.
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 p…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 1\. Ability to provide informed consent in English. * 2\. Provision of signed and dated informed consent form. * 3\. Stated willingness to comply with all study procedures and availability for the duration of the study. * 4\. Male and female participants aged 18-65 years. * 5\. CLBP, uniformly defined as high-impact or bothersome non-cancer low back pain lasting ≥ three months that occurs most days and limits life or work activities. * 6\. At least moderate pain-related disability as measured by a total score on the ODI ≥ 15. * 7\. For women of childbearing potential, mu…
Interventions
- DrugPsilocybin 10 mg
Two 5 mg psilocybin capsuels will be administered to participants randomized into the low-dose psilocybin group.
- DrugPsilocybin 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.
- DrugNiacin 100 mg
Two 100 mg niacin capsuels will be adminstered to participants randomized to the placebo group.
Location
- Connecticut Mental Health CenterNew Haven, Connecticut