Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07306364
PHASE2

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

Sponsor: Yale University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-06

Completion Date

2029-06

Last Updated

2025-12-29

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States