drugset / Trial / NCT07306364
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Phase 2
Not yet recruiting
45 enrolled
Yale University
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupQuadruple-blindSupportive care
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.
Timeline
- Start
- 2026-06
- Primary completion
- 2029-06
- Completion
- 2029-06
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Psilocybin | Other / unclassified | 10 mg | — |
| Comparator | Psilocybin | Other / unclassified | 25 mg | — |