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Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

{ "Psilocybin-Assisted Physical Therapy for Chronic Low Back Pain", "This study is investigating whether psilocybin, a psychedelic compound, can help people with chronic low back pain (CLBP) who are also receiving physical therapy. Researchers want to see if a single dose of psilocybin (10 mg or 25 mg) given before physical therapy can improve your awareness of your body's sensations (interoceptive awareness) and lead to less pain and better physical function. A placebo (niacin 100 mg) will also be used for comparison. The study is looking for 45 participants between 18 and 65 years old who can provide informed consent in English. The study's success will be measured by changes in your interoceptive awareness, pain levels, and how well you can do daily activities over 8 weeks. The current recruitment status is unclear.", "design": "This is a randomized, double-blind, placebo-controlled study involving approximately 45 participants. Participants will receive either a low dose of psilocybin, a moderate dose of psilocybin, or a placebo (niacin).", "commitments": "Participants will receive a single dose of psilocybin or niacin, followed by a standardized course of physical therapy. Measurements will be taken at baseline, 4 weeks post-dose, and 8 weeks post-dose.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 8 weeks after receiving the study dose, with measurements taken at 4 and 8 weeks.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07306364

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

Not Yet Recruiting
PHASE2Ages 18–65InterventionalSupportive care
Yale University
~45 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Psilocybin 10 mgPsilocybin 25 mgNiacin 100 mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in interoceptive awareness as measured by the Multidimensional Assessment of Interoceptive Awareness-2 from 4 weeks post-dose to 8 weeks post dose
Measured over 4 weeks post dose, 8 weeks post-dose
+2 more outcomes measured

Conditions

Chronic Low Back Pain (CLBP)
Physical Therapy
Psilocybin

Explore related trials

Chronic low back pain

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

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

Who to contact

Julia Meyerovich, M.S.
[email protected]
203-932-5711 · ext. 14805
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Eligibility criteria

Inclusion

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

1\. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.
2\. Personal or family history of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with psychotic features; any history of substance-induced psychosis or current psychotic symptoms at Screening per the Brief Psychiatric Rating Scale.
3\. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.
4\. Lifetime use of classic psychedelics (5-HT2A agonists) within the preceding 12 months, or unwillingness to abstain from their use for up to 4 weeks post-dose.
5\. Current moderate or severe depression, as indicated by a score of ≥ 3 on the depression subscale (items 1 and 2) of the Patient Health Questionnaire-4 (PHQ-4).
6\. Total score on the ODI ≥ 35, indicating an individual is "completely disabled."
7\. Meeting DSM-5 criteria for alcohol or substance use disorders (other than tobacco use disorder) within the last year; use of THC-containing products \> 2×/week over the past 30 days or unwillingness to abstain for at least 1 week pre-dose through 4 weeks post-dose. Abstinence will be confirmed via point-of-care urine 11-nor-9-carboxy-THC testing with a cut-off ≤ 50 ng/mL.
8\. Clinically significant medical disorders (e.g., moderate-to-severe hepatic impairment \[Child-Pugh B/C\], AST/ALT \> 2× ULN, bilirubin \> 1.5× ULN, eGFR \< 50 mL/min/1.73 m², diabetes, uncontrolled thyroid disease).
9\. Neurological conditions altering nociceptive response (e.g., stroke, neuropathy) or history of seizure/head injury with \> 30 minutes loss of consciousness.
10\. Contraindications to nociceptive testing (e.g., untreated hypertension \> 140/90 mmHg).
11\. Current use of serotonergic medications (e.g., SSRIs, SNRIs, TCAs).
12\. Current regular use of medications affecting pain (e.g., opioids, gabapentinoids, cyclobenzaprine).
13\. Current regular use of inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.
14\. Major neurocognitive disorders (e.g., dementia) or any cognitive deficit impairing consent/participation.
15\. Abnormal EKG findings (e.g., ischemia, infarct patterns, bundle branch block, atrial fibrillation, QTcF ≥ 450 ms).
16\. Resting QTcF prolongation or other torsades de pointes risk factors (uncontrolled electrolyte disturbances, family history of sudden death, torsadogenic medications).
17\. Any other condition that, in the investigator's judgment, would compromise safety or ability to complete the study.
18\. Known or suspected cardiovascular disease, including but not limited to atrial fibrillation, coronary artery disease, history of myocardial infarction, structural heart disease, congestive heart failure, or uncontrolled hypertension.

What this trial measures

  • Change in interoceptive awareness as measured by the Multidimensional Assessment of Interoceptive Awareness-2 from 4 weeks post-dose to 8 weeks post dose4 weeks post dose, 8 weeks post-dose

    The Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) is a validated 37-item, self-report instrument assessing mind-body connections (i.e., interoceptive awareness). MAIA-2 scoring involves rating the 37 items on a 0 (never) to 5 (always) Likert scale, resulting in scores for eight subscales (Noticing, Not-distracting, Not-worrying, Attention regulation, Emotional awareness, Self-regulation, Body Listening, Trusting). Scores for each of the 8 scales are averaged (sum of items divided by number of subscale items). Higher scores indicate better interoceptive awareness. Change = (8-week post-dose score - 4-week post-dose score).

  • Change in Pain, Enjoyment, and General Activity (PEG) total score at 8 weeks post dose4 weeks post-dose, 8 weeks post-dose

    The Pain, Enjoyment, General Activity (PEG) Scale is a 3-item questionnaire used to measure how chronic pain affects a person's life, focusing on average pain intensity (P), interference with enjoyment (E), and interference with general activity (G) using 0-10 Likert scale for each item. The final PEG score is calculated by adding the three scores and dividing by three. Scores range from 0-10, with higer scores indicating higher pain impact. Change= (8-week post-dose score - 4-week post-dose score).

  • Change in functional disability measured by the Oswestry Disability Index (ODI) from baseline to 8 weeks post-dose.Baseline (Day 0), 8 weeks post-dose

    The Oswestry Disability Index (ODI) is a widely used, 10-question self-report questionnaire that measures functional disability and quality of life for people with low back pain, assessing activities like walking, sitting, sleeping, and pain intensity, with scores ranging from 0-100% categorized into minimal (0-20%), moderate (21-40%), severe (41-60%), crippled (61-80%), and bed-bound (81-100%) disability. Change = (8-week post-dose score - baseline \[day 0\] score)