Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07306364
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Low-dose psilocybin (10 mg)
  • Active Comparator: Moderate-dose psilocybin (25 mg)
  • Placebo Comparator: Placebo (niacin).

Primary Outcome Measure

Change in interoceptive awareness as measured by the Multidimensional Assessment of Interoceptive Awareness-2 from 4 weeks post-dose to 8 weeks post dose [ Time Frame: 4 weeks post dose, 8 weeks post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterNew HavenConnecticut06519
Thomas McMahon
[email protected]
203-974-5950

Find similar trials in New Haven, CT

By research site
Connecticut Mental Health Center· New Haven, CT

Related Studies