Psilocybin in Chronic Low Back Pain and Depression

Summary

This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.

Timeline

Start

2024-04-22

Primary completion

2026-07-30

Completion

2026-08-30

Publications

• Background Mak HW, Schneider S. Individual differences in momentary pain-affect coupling and their associations with mental health in patients with chronic pain. J Psychosom Res. 2020 Nov;138:110227. doi: 10.1016/j.jpsychores.2020.110227. Epub 2020 Aug 28.
• Background Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
• Background Sullivan MJ, Bishop SR, & Pivik J (1995). The pain catastrophizing scale: development and validation. Psychol Assess, 7(4): 524.
• Background Vanderlind WM, Everaert J, Joormann J. Positive emotion in daily life: Emotion regulation and depression. Emotion. 2022 Oct;22(7):1614-1624. doi: 10.1037/emo0000944. Epub 2021 Mar 4.
• Background Yaden, D. B., Kaufman, S. B., Hyde, E., Chirico, A., Gaggioli, A., Zhang, J. W., & Keltner, D. (2019). The development of the Awe Experience Scale (AWE-S): A multifactorial measure for a complex emotion. The Journal of Positive Psychology, 14(4): 474-488.
• Background Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16.
• Background Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
• Background Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
• Background Griffiths RR, Richards WA, McCann U, Jesse R. Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology (Berl). 2006 Aug;187(3):268-83; discussion 284-92. doi: 10.1007/s00213-006-0457-5. Epub 2006 Jul 7.
• Background Gratz, K. L., & Roemer, L. (2004). Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology & Behavioral Assessment, 26(1): 41
• Background George SZ, Calley D, Valencia C, Beneciuk JM. Clinical Investigation of Pain-related Fear and Pain Catastrophizing for Patients With Low Back Pain. Clin J Pain. 2011 Feb;27(2):108-15. doi: 10.1097/AJP.0b013e3181f21414.
• Background Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.
• Background Flink IL, Boersma K, Linton SJ. Pain catastrophizing as repetitive negative thinking: a development of the conceptualization. Cogn Behav Ther. 2013;42(3):215-23. doi: 10.1080/16506073.2013.769621.
• Background Finan PH, Garland EL. The role of positive affect in pain and its treatment. Clin J Pain. 2015 Feb;31(2):177-87. doi: 10.1097/AJP.0000000000000092.
• Background Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
• Background Dittrich A. The standardized psychometric assessment of altered states of consciousness (ASCs) in humans. Pharmacopsychiatry. 1998 Jul;31 Suppl 2:80-4. doi: 10.1055/s-2007-979351.
• Background Davis AK, Barrett FS, So S, Gukasyan N, Swift TC, Griffiths RR. Development of the Psychological Insight Questionnaire among a sample of people who have consumed psilocybin or LSD. J Psychopharmacol. 2021 Apr;35(4):437-446. doi: 10.1177/0269881120967878. Epub 2021 Jan 9.
• Background Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
• Background Barrett FS, Bradstreet MP, Leoutsakos JS, Johnson MW, Griffiths RR. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms. J Psychopharmacol. 2016 Dec;30(12):1279-1295. doi: 10.1177/0269881116678781. Epub 2016 Nov 17.
• Background McCracken LM, Yang SY. The role of values in a contextual cognitive-behavioral approach to chronic pain. Pain. 2006 Jul;123(1-2):137-45. doi: 10.1016/j.pain.2006.02.021. Epub 2006 Mar 29.
• Background Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.
• Background Clifton JDW, Yaden DB. Brief measures of the four highest-order primal world beliefs. Psychol Assess. 2021 Dec;33(12):1267-1273. doi: 10.1037/pas0001055. Epub 2021 Jul 1.
• Background Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
• Background Nakonezny PA, Carmody TJ, Morris DW, Kurian BT, Trivedi MH. Psychometric evaluation of the Snaith-Hamilton pleasure scale in adult outpatients with major depressive disorder. Int Clin Psychopharmacol. 2010 Nov;25(6):328-33. doi: 10.1097/YIC.0b013e32833eb5ee.
• Background Shiota, M. N., Keltner, D., & John, O. P. (2006). Positive emotion dispositions differentially associated with Big Five personality and attachment style. The Journal of Positive Psychology, 1(2), 61-71. DOI: 10.1080/17439760500510833
• Background Von Korff M, DeBar LL, Krebs EE, Kerns RD, Deyo RA, Keefe FJ. Graded chronic pain scale revised: mild, bothersome, and high-impact chronic pain. Pain. 2020 Mar;161(3):651-661. doi: 10.1097/j.pain.0000000000001758.
• Background Wicksell RK, Lekander M, Sorjonen K, Olsson GL. The Psychological Inflexibility in Pain Scale (PIPS)--statistical properties and model fit of an instrument to assess change processes in pain related disability. Eur J Pain. 2010 Aug;14(7):771.e1-14. doi: 10.1016/j.ejpain.2009.11.015. Epub 2010 Jan 27.
• Background Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.

Drugs

Indications