Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Not yet recruitingPhase 2NCT07306364
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (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.
Study details
- Official title
- Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes
- Conditions
- Interventions
- Drug: Psilocybin 10 mg
- Drug: Psilocybin 25 mg
- Drug: Niacin 100 mg
- Sponsor
- Yale University
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2026-10
- Primary completion
- 2029-06
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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, must have a negative urine pregnancy test at screening and immediately before dose administration. * Negative urine pregnancy test at screening and immediately before dose administration. * Use of one highly effective contraception (e.g., IUD, barrier method) for ≥ 1 month prior to screening. * 8\. Participants are required to commit to employing dual contraceptive methods throughout the study and to abstain from sperm or egg donation during the study period and for 28 days following the final drug dose for ova, and for 90 days following the final drug dose for sperm. Dual contraceptive methods encompass the use of a barrier contraceptive, such as condoms, coupled with another effective method capable of preventing pregnancy, such as oral or parenteral contraceptives, intrauterine devices, spermicide, and the like. * 9\. Resting blood pressure ≤ 140/90 mmHg (average of three screenings) and resting heart rate 60-100 bpm. * 10\. Normal screening EKG: QTcF \< 450 ms; no clinically significant arrhythmias, ischemia, or bundle branch block. * 11\. Hepatic and renal function within acceptable limits: AST/ALT ≤ 2× ULN; bilirubin ≤ 1.5× ULN; eGFR ≥ 50 mL/min/1.73 m². * 12\. Ability to safely ingest oral capsules for the dosing visit. * 13\. Safe transportation plan after the dosing session (e.g., designated driver). * 14\. Signed medical release permitting the study team to communicate with outside providers for medication/therapy history or crisis management. * 15\. Designation of an adult emergency contact (relative, spouse, close friend) willing to monitor for mood/behavior changes post-dose and provide transportation if needed. * 16\. Agreement to attend preparatory and integration sessions, follow-up visits, and to respond to telephone/email contacts. Exclusion Criteria: * 1\. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder. * 2\. Personal or famil…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07306364