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Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

NCT07306364 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Joao De Aquino, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306364 on ClinicalTrials.gov