Chronic Low Back Pain (CLBP)Phase 2NCT07306364

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

A Phase 2 study testing Psilocybin 10 mg, Psilocybin 25 mg and Niacin 100 mg in people with Chronic Low Back Pain (CLBP) and Physical Therapy, run by Yale University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Low Back Pain (CLBP), Physical Therapy, Psilocybin
What is being tested?: Psilocybin 10 mg, Psilocybin 25 mg and Niacin 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Dec 2026to Jun 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 21-65 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.

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7. For women of childbearing potential, must have a negative urine pregnancy test at screening and immediately before dose administration.
o 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 ≤ 135/85 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. Access to a personal mobile device that can access the internet.
17. Agreement to attend preparatory and integration sessions, follow-up visits, and to respond to telephone/email contacts.

Who cannot join

1. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.
2. History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc.
3. Personal or first-degree 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. Personal symptoms will be evaluated during screening using the Brief Psychiatric Rating Scale 88, family history will be evaluated during the clinical interview.
4. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.
5. Use of classic psychedelics (5-HT2A agonists) within the preceding 12 months.
6. Unwillingness to abstain from the use of psychedelics, THC, and other substances for at least 7 days pre-dose through 4 weeks post-dose. THC abstinence will be confirmed via point-of-care urine 11-nor-9-carboxy-THC testing with a cut-off ≤ 50 ng/mL87,88.

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7. 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).
8. Total score on the ODI ≥ 35, indicating an individual is "completely disabled."
9. Meeting DSM-5 criteria for alcohol or substance use disorders (other than tobacco use disorder) within the last year.
10. 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).
11. 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, and/or uncontrolled hypertension. Participants whose hypertension is controlled (i.e., on a stable medication regimen) may still be eligible provided their screening blood pressure meets the threshold criterion.
12. Neurological conditions altering nociceptive response (e.g., stroke, neuropathy) or history of seizure/head injury with > 30 minutes loss of consciousness.
13. Contraindications to nociceptive testing (e.g., Raynaud Syndrome, untreated hypertension > 135/85 mmHg).
14. Current use of serotonergic medications (e.g., SSRIs, SNRIs, TCAs).
15. Current regular use of medications affecting pain (e.g., opioids, gabapentinoids, cyclobenzaprine).
16. Current regular use of inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.
17. Current regular use of 5-hydroxytryptophan, L-tryptophan, and/or St. John's wort.
18. Any cognitive deficit impairing consent/participation.
19. Major neurocognitive disorders (e.g., dementia, delirium, amnestic).
20. Abnormal EKG findings (e.g., ischemia, infarct patterns, bundle branch block, atrial fibrillation, QTcF ≥ 450 ms).
21. Resting QTcF prolongation or other torsades de pointes risk factors (e.g. uncontrolled electrolyte disturbances, family history of sudden death, torsadogenic medications).
22. Any other condition that, in the investigator's judgment, would compromise safety or ability to complete the study.
23. Allergy to psilocybin, Microcrystalline Cellulose (MCC), or Niacin.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia Meyerovich, M.S. contact

203-932-5711 ext. 14805

julia.meyerovich@yale.edu

Joao De Aquino, M.D. contact

203-974-7560

joao.deaquinolima@yale.edu

United States1 site

Connecticut Mental Health Center
New Haven, Connecticut, 06519
Joao P. De Aquino, M.D., 203-932-5711 ext. 12916, joao.deaquinolima@yale.edu

Other trials in United States

About this study

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

Read the detailed description

Preclinical and human studies suggest that psilocybin can temporarily disrupt rigid, maladaptive patterns of brain activity and promote longer-lasting changes in how the brain processes internal sensations. People with chronic pain who have used psilocybin qualitatively describe feeling more aware of their bodies, able to reinterpret pain sensations, and less distressed and disabled by their pain.

Building on these mechanistic insights, this randomized, double-blind, placebo-controlled trial will evaluate a single dose of low- (10 mg), moderate-dose (25 mg), or placebo (niacin) administered prior to a standardized course of physical therapy (PT) in adults with chronic low back pain (CLBP). Participants in both treatment groups will receive a course of PT that is consistent with what would be delivered outside of involvement in the research study. That is, the study is evaluating psilocybin as an adjunct to PT delivered in a community outpatient PT clinic. By testing whether psilocybin-induced recalibration of brain networks can enhance engagement with and outcomes of PT, this study aims to establish a novel, non-opioid integrative strategy to relieve CLBP and restore functional recovery.

Conditions: Chronic Low Back Pain (CLBP), Physical Therapy, Psilocybin
Being tested: Psilocybin 10 mg, Psilocybin 25 mg, Niacin 100 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psilocybin 10 mgDrug
Two 5 mg psilocybin capsules will be administered to participants randomized into the low-dose psilocybin group.
Psilocybin 25 mgDrug
One 25 mg psilocybin capsule and one 25 mg Microcrystalline cellulose (MCC) capsule will be administered to participants randomized into the moderate-dose psilocybin group.
Niacin 100 mgDrug
Two 100 mg niacin capsules will be administered to participants randomized to the placebo group.

Study groups in NCT07306364
Study group	Role	What they receive
Low-dose psilocybin (10 mg)	Active comparator	Not described Receives: Drug: Psilocybin 10 mg
Moderate-dose psilocybin (25 mg)	Active comparator	Not described Receives: Drug: Psilocybin 25 mg
Placebo (niacin)	Placebo comparator	Not described Receives: Drug: Niacin 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in interoceptive awareness as measured by the Multidimensional Assessment of Interoceptive Awareness-2 from 4 weeks post-dose to 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).
Measured: 4 weeks post dose, 8 weeks post-dose
Change in Pain, Enjoyment, and General Activity (PEG) total score at 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).
Measured: 4 weeks post-dose, 8 weeks post-dose
Change in functional disability measured by the Oswestry Disability Index (ODI) from baseline to 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)
Measured: Baseline (Day 0), 8 weeks post-dose

Secondary outcomes (12)

Physical activity measured by average daily step count via daily Experience Sampling Monitoring (ESM)
Participants will record their daily step count via study-provided pedometer from 4 weeks post dose to 8 weeks post-dose. The average step count will be assessed.
Measured: Daily for approximately 28 days post-dose
Change in functional mobility from 4 weeks post-dose to 8 weeks post-dose measured by the 10-Meter Walk Test (10MWT)
The 10-Meter Walk Test (10MWT) is a common physical therapy assessment measuring how fast someone walks over a short distance, typically 10 meters. The 10MWT will be used to evaluate gait velocity. Change= (8-week post dose score - 4-week post-dose score)
Measured: 4 weeks post-dose, 8 weeks post-dose
Change in functional mobility from 4 weeks post-dose to 8 weeks post-dose measured by the 30-Second Sit to Stand (30STS)
The 30 Second Sit to Stand Test (30STS) is a common physical therapy assessment recording the number of times a person can stand from a chair over 30 seconds. The 30STS will evaluate functional lower extremity strength and endurance. Change= (8-week post dose score - 4-week post-dose score).
Measured: 4 weeks post-dose, 8 weeks post-dose
Change in back-specific strength from 4 weeks post-dose to 8 weeks post-dose, measured by myotomal dynamometry spanning vertebrae L2 to S2 using an isometric deadlift test.
Myotomal dynamometry spanning vertebral levels L2-S2 will be performed by testing the muscle groups associated with each spinal nerve root using a handheld dynamometer or graded manual resistance. Change scores will be calculated as: 8-week post-dose value minus 4-week post-dose value
Measured: 4 weeks post-dose, 8 weeks post-dose
Nociceptive sensitivity assessed by a composite multimodal Quantitative Sensory Testing (QST) battery
Quantitative sensory testing (QST) will assess multiple pain modalities including pressure, thermal, and cold pressor, pain threshold and tolerance; Mechanical temporal summation; Thermal temporal summation; and Conditioned pain modulation. All raw QST values will be converted to standardized Z-scores. A general pain sensitivity score will be derived by averaging the Z-scores for pressure pain threshold, heat pain threshold, heat pain tolerance, and cold pressor latency; higher scores indicate greater overall pain sensitivity. Central sensitization will be quantified by averaging the Z-scores for mechanical temporal summation, thermal temporal summation, conditioned pain modulation, and after-sensation ratings; positive values reflect a pronociceptive state, while negative values indicate an antinociceptive state.
Measured: 4 weeks post-dose, 8 weeks post-dose
Fear of movement measured using the physical activity subscale of the Fear Avoidance Beliefs Questionnaire (FABQ-PA) mean score
The Fear Avoidance Beliefs Questionnaire (FABQ-PA) is a 5-item subscale of the broader FABQ, used to measure how much a person's fear of pain makes them believe physical activity will worsen their condition, leading to avoidance. Responses are rated from 0 (completely disagree) to 6 (completely agree) for a maximum of 24 points. A score of 15 or higher often signifies significant fear-avoidance beliefs about physical activity.
Measured: 4 weeks post-dose, 8 weeks post-dose
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS-6) and Situational Catastrophizing Questionnaire (SCQ) mean score
The Pain Catastrophizing Scale (PCS-6) is a 6-item version of the Pain Catastrophizing Scale (PCS), designed to quickly measure negative thinking about pain (rumination, magnification, helplessness). The PCS-6 is scored on a Likert scale with values from 0 ("Not at all") to 4 ("All the time"). Scores range from 0-24, with higher scores indicating greater pain catastrophizing.
Measured: 4 weeks post-dose, 8 weeks post-dose
Situational pain catastrophizing measured by the Situational Catastrophizing Questionnaire (SCQ) mean score
The Situational Catastrophizing Questionnaire consists of 6 items that assess negative thoughts and feelings in response to a specific pain stimulus. The SCQ is scored on a Likert scale with values from 0 ("Not at all") to 4 ("All the time"). Scores range from 0-24, with higher scores indicating greater negative thoughts and feelings. The SCQ will be asseesed after participants complete the QST battery.
Measured: 4 weeks post-dose, 8 weeks post-dose
Daily pain intensity/interference measured by the Pain, Enjoyment, General Activity (PEG) Scale via daily Experience Sampling Monitoring (ESM) mean score
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. Participants will complete the PEG Scale daily via ESM from 4 weeks post dose to 8 weeks post-dose.
Measured: Daily for approximitely 28 days post-dose
Daily pain affect measured by the Positive and Negative Affect Schedule (PANAS) via daily Experience Sampling Monitoring (ESM) mean score
the Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire listing adjectives relating to Positive Affect (PA) (e.g., excited, inspired) and Negative Affect (NA) (e.g., distressed, afraid). Items are rated on a Likert scale ranging from 1 "Very slightly or not at all" to 5 "extremely". The PANAS yeilds separate PA and NA scores, each ranging from 10 to 50. Higher PA scores indicate more positive feelings, while higher NA scores indicate more negative feelings. These scores are used to track emotional states over time.
Participants will complete the PANAS daily via ESM from 4 weeks post dose to 8 weeks post-dose.
Measured: Daily for approximitely 28 days post-dose
Psychedelic-related adverse events will be measured by the Swiss Psychedelic Side Effect Inventory (SPSI)
The Swiss Psychedelic Side Effect Inventory (SPSI) is a standardized 32-item questionnaire designed for the systematic assessment and recording of adverse effects from psychedelics. For each reported side effect, the SPSI assesses: Severity (light, moderate, strong), Duration, Impact (from very disadvantageous to very advantageous), and Treatment-relatedness. Number of The number of participants, in each group, experiencing at least one event on the SPSI will be tabulated by event frequency and severity and summarized in descriptive tables.
Measured: 8 hours post-dose
Subjective psychedelic effects will be measured by the 5-Dimensional Altered States of Consciousness Scale (5D-ASC) mean score
The 5-Dimensional Altered States of Consciousness Scale (5D-ASC) is a 94-item self-report questionnaire used to quantify participants subjective experiences of altered states of consciousness induced by psychedelics. Items are rated using a 100-millimeter visual analogue scale (VAS), indicating to what extent the experience applied to them during or after a specific event (e.g., from "No, not more than usually" to "Yes, very much more than usually"). The 5D-ASC is divided into 11 subscales: Oceanic Boundlessness, Anxious Ego Dissolution, Visionary Restructuralization, Auditory Alterations, Reduction of Vigilance. The scores within each subscale are averaged to produce a mean score for that specific subscale or dimension. Descriptives for the 5D-ASC will be tabulated by event frequency and severity and summarized in descriptive tables.
Measured: 8 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2026Jun 2029

First posted29 Dec 2025
Study startDec 2026 (estimated)
Primary completionJun 2029 (estimated)
Study completionJun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Adults with CLBP beginning a course of PT will be allocated equally into three parallel arms. Participants will receive a single oral dose of either low-dose psilocybin (10 mg), moderate-dose psilocybin (25 mg), or placebo (niacin). All three groups will follow identical study procedures.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07306364
Sponsor's protocol ID: 2000041668
Status last verified: Aug 2026
First submitted: 23 Dec 2025
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bornemann J, Close JB, Spriggs MJ, Carhart-Harris R, Roseman L. Self-Medication for Chronic Pain Using Classic Psychedelics: A Qualitative Investigation to Inform Future Research. Front Psychiatry. 2021 Nov 12;12:735427. doi: 10.3389/fpsyt.2021.735427. eCollection 2021.
PubMed 34867525
Skosnik PD, Sloshower J, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D'Souza DC. Sub-acute effects of psilocybin on EEG correlates of neural plasticity in major depression: Relationship to symptoms. J Psychopharmacol. 2023 Jul;37(7):687-697. doi: 10.1177/02698811231179800. Epub 2023 Jun 30.
PubMed 37392016
Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13.
PubMed 27208316
Barba T, Buehler S, Kettner H, Radu C, Cunha BG, Nutt DJ, Erritzoe D, Roseman L, Carhart-Harris R. Effects of psilocybin versus escitalopram on rumination and thought suppression in depression. BJPsych Open. 2022 Sep 6;8(5):e163. doi: 10.1192/bjo.2022.565.
PubMed 36065128
Carhart-Harris RL, Roseman L, Bolstridge M, Demetriou L, Pannekoek JN, Wall MB, Tanner M, Kaelen M, McGonigle J, Murphy K, Leech R, Curran HV, Nutt DJ. Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms. Sci Rep. 2017 Oct 13;7(1):13187. doi: 10.1038/s41598-017-13282-7.
PubMed 29030624
Siegel JS, Subramanian S, Perry D, Kay BP, Gordon EM, Laumann TO, Reneau TR, Metcalf NV, Chacko RV, Gratton C, Horan C, Krimmel SR, Shimony JS, Schweiger JA, Wong DF, Bender DA, Scheidter KM, Whiting FI, Padawer-Curry JA, Shinohara RT, Chen Y, Moser J, Yacoub E, Nelson SM, Vizioli L, Fair DA, Lenze EJ, Carhart-Harris R, Raison CL, Raichle ME, Snyder AZ, Nicol GE, Dosenbach NUF. Psilocybin desynchronizes the human brain. Nature. 2024 Aug;632(8023):131-138. doi: 10.1038/s41586-024-07624-5. Epub 2024 Jul 17.
PubMed 39020167
Zhao X, Du Y, Yao Y, Dai W, Yin Y, Wang G, Li Y, Zhang L. Psilocybin promotes neuroplasticity and induces rapid and sustained antidepressant-like effects in mice. J Psychopharmacol. 2024 May;38(5):489-499. doi: 10.1177/02698811241249436. Epub 2024 Apr 28.
PubMed 38680011
Weleff J, Nunes JC, Costa GPA, Sofuoglu M, MacLean RR, De Aquino JP. From taboo to treatment: The emergence of psychedelics in the management of pain and opioid use disorder. Br J Clin Pharmacol. 2024 Dec;90(12):3036-3053. doi: 10.1111/bcp.16045. Epub 2024 Apr 16.
PubMed 38627909
Shao LX, Liao C, Gregg I, Davoudian PA, Savalia NK, Delagarza K, Kwan AC. Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo. Neuron. 2021 Aug 18;109(16):2535-2544.e4. doi: 10.1016/j.neuron.2021.06.008. Epub 2021 Jul 5.
PubMed 34228959

Interested in taking part?

Julia Meyerovich, M.S.

203-932-5711 ext. 14805

julia.meyerovich@yale.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes
ClinicalTrials.gov ID: NCT07306364
Acronym / sponsor ID: 2000041668
Conditions: Chronic Low Back Pain (CLBP), Physical Therapy, Psilocybin
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Dec 2026 (estimated)
Primary completion: Jun 2029 (estimated)
Study completion: Jun 2029 (estimated)
First posted: 29 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Adults with CLBP beginning a course of PT will be allocated equally into three parallel arms. Participants will receive a single oral dose of either low-dose psilocybin (10 mg), moderate-dose psilocybin (25 mg), or placebo (niacin). All three groups will follow identical study procedures.

Arm	Type	Receives
Low-dose psilocybin (10 mg)	Active comparator	Drug: Psilocybin 10 mg
Moderate-dose psilocybin (25 mg)	Active comparator	Drug: Psilocybin 25 mg
Placebo (niacin)	Placebo comparator	Drug: Niacin 100 mg

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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 21-65 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.

Key exclusion criteria (23 listed)

1. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.
2. History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc.
3. Personal or first-degree 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. Personal symptoms will be evaluated during screening using the Brief Psychiatric Rating Scale 88, family history will be evaluated during the clinical interview.
4. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.
5. Use of classic psychedelics (5-HT2A agonists) within the preceding 12 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psilocybin 10 mgTwo 5 mg psilocybin capsules will be administered to participants randomized into the low-dose psilocybin group.	Drug	Low-dose psilocybin (10 mg)
Psilocybin 25 mgOne 25 mg psilocybin capsule and one 25 mg Microcrystalline cellulose (MCC) capsule will be administered to participants randomized into the moderate-dose psilocybin group.	Drug	Moderate-dose psilocybin (25 mg)
Niacin 100 mgTwo 100 mg niacin capsules will be administered to participants randomized to the placebo group.	Drug	Placebo (niacin)

Primary outcome

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
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 dose
Time frame: 4 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.
Time frame: 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)

12 secondary outcomes

Physical activity measured by average daily step count via daily Experience Sampling Monitoring (ESM)
Time frame: Daily for approximately 28 days post-dose
Change in functional mobility from 4 weeks post-dose to 8 weeks post-dose measured by the 10-Meter Walk Test (10MWT)
Time frame: 4 weeks post-dose, 8 weeks post-dose
Change in functional mobility from 4 weeks post-dose to 8 weeks post-dose measured by the 30-Second Sit to Stand (30STS)
Time frame: 4 weeks post-dose, 8 weeks post-dose
Change in back-specific strength from 4 weeks post-dose to 8 weeks post-dose, measured by myotomal dynamometry spanning vertebrae L2 to S2 using an isometric deadlift test.
Time frame: 4 weeks post-dose, 8 weeks post-dose
Nociceptive sensitivity assessed by a composite multimodal Quantitative Sensory Testing (QST) battery
Time frame: 4 weeks post-dose, 8 weeks post-dose
Fear of movement measured using the physical activity subscale of the Fear Avoidance Beliefs Questionnaire (FABQ-PA) mean score
Time frame: 4 weeks post-dose, 8 weeks post-dose
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS-6) and Situational Catastrophizing Questionnaire (SCQ) mean score
Time frame: 4 weeks post-dose, 8 weeks post-dose
Situational pain catastrophizing measured by the Situational Catastrophizing Questionnaire (SCQ) mean score
Time frame: 4 weeks post-dose, 8 weeks post-dose
Daily pain intensity/interference measured by the Pain, Enjoyment, General Activity (PEG) Scale via daily Experience Sampling Monitoring (ESM) mean score
Time frame: Daily for approximitely 28 days post-dose
Daily pain affect measured by the Positive and Negative Affect Schedule (PANAS) via daily Experience Sampling Monitoring (ESM) mean score
Time frame: Daily for approximitely 28 days post-dose
Psychedelic-related adverse events will be measured by the Swiss Psychedelic Side Effect Inventory (SPSI)
Time frame: 8 hours post-dose
Subjective psychedelic effects will be measured by the 5-Dimensional Altered States of Consciousness Scale (5D-ASC) mean score
Time frame: 8 hours post-dose

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Background: PubMed 34867525Bornemann J, Close JB, Spriggs MJ, Carhart-Harris R, Roseman L. Self-Medication for Chronic Pain Using Classic Psychedelics: A Qualitative Investigation to Inform Future Research. Front Psychiatry. 2021 Nov 12;12:735427. doi: 10.3389/fpsyt.2021.735427. eCollection 2021.
Background: PubMed 37392016Skosnik PD, Sloshower J, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D'Souza DC. Sub-acute effects of psilocybin on EEG correlates of neural plasticity in major depression: Relationship to symptoms. J Psychopharmacol. 2023 Jul;37(7):687-697. doi: 10.1177/02698811231179800. Epub 2023 Jun 30.
Background: PubMed 27208316Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13.
Background: PubMed 36065128Barba T, Buehler S, Kettner H, Radu C, Cunha BG, Nutt DJ, Erritzoe D, Roseman L, Carhart-Harris R. Effects of psilocybin versus escitalopram on rumination and thought suppression in depression. BJPsych Open. 2022 Sep 6;8(5):e163. doi: 10.1192/bjo.2022.565.
Background: PubMed 29030624Carhart-Harris RL, Roseman L, Bolstridge M, Demetriou L, Pannekoek JN, Wall MB, Tanner M, Kaelen M, McGonigle J, Murphy K, Leech R, Curran HV, Nutt DJ. Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms. Sci Rep. 2017 Oct 13;7(1):13187. doi: 10.1038/s41598-017-13282-7.
Background: PubMed 39020167Siegel JS, Subramanian S, Perry D, Kay BP, Gordon EM, Laumann TO, Reneau TR, Metcalf NV, Chacko RV, Gratton C, Horan C, Krimmel SR, Shimony JS, Schweiger JA, Wong DF, Bender DA, Scheidter KM, Whiting FI, Padawer-Curry JA, Shinohara RT, Chen Y, Moser J, Yacoub E, Nelson SM, Vizioli L, Fair DA, Lenze EJ, Carhart-Harris R, Raison CL, Raichle ME, Snyder AZ, Nicol GE, Dosenbach NUF. Psilocybin desynchronizes the human brain. Nature. 2024 Aug;632(8023):131-138. doi: 10.1038/s41586-024-07624-5. Epub 2024 Jul 17.
Background: PubMed 38680011Zhao X, Du Y, Yao Y, Dai W, Yin Y, Wang G, Li Y, Zhang L. Psilocybin promotes neuroplasticity and induces rapid and sustained antidepressant-like effects in mice. J Psychopharmacol. 2024 May;38(5):489-499. doi: 10.1177/02698811241249436. Epub 2024 Apr 28.
Background: PubMed 38627909Weleff J, Nunes JC, Costa GPA, Sofuoglu M, MacLean RR, De Aquino JP. From taboo to treatment: The emergence of psychedelics in the management of pain and opioid use disorder. Br J Clin Pharmacol. 2024 Dec;90(12):3036-3053. doi: 10.1111/bcp.16045. Epub 2024 Apr 16.
Background: PubMed 34228959Shao LX, Liao C, Gregg I, Davoudian PA, Savalia NK, Delagarza K, Kwan AC. Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo. Neuron. 2021 Aug 18;109(16):2535-2544.e4. doi: 10.1016/j.neuron.2021.06.008. Epub 2021 Jul 5.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Julia Meyerovich, M.S. contact

203-932-5711 ext. 14805

julia.meyerovich@yale.edu

Joao De Aquino, M.D. contact

203-974-7560

joao.deaquinolima@yale.edu

Joao De Aquino, M.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin 10 mg, Psilocybin 25 mg and Niacin 100 mg in people with Chronic Low Back Pain (CLBP) and Physical Therapy, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia Meyerovich, M.S. (203-932-5711 ext. 14805, julia.meyerovich@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07306364, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.