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Methylphenidate / Chronic Low Back Pain / Depression · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registry record for a planned single-dose psilocybin study in patients with comorbid chronic low back pain and depression. No results have been posted; the trial is currently recruiting and will use ecological momentary assessment and quantitative sensory testing to explore mechanisms of action rather than definitive clinical efficacy.
Phase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Chronic Low-back Pain, Depression; age from 21 Years; to 80 Years. Intervention: Psilocybin. Compared with: Methylphenidate — Active Comparator. n = 40. 1 site: United States.
This is a Phase 1 registry record for a planned single-dose psilocybin study in patients with comorbid chronic low back pain and depression. No results have been posted; the trial is currently recruiting and will use ecological momentary assessment and quantitative sensory testing to explore mechanisms of action rather than definitive clinical efficacy.
No published data on efficacy, safety, tolerability, or mechanism from this study is available
This is a mechanistic Phase 1 trial and should not yet inform clinical practice. Results, when posted, may inform understanding of psilocybin's effects on pain and mood but are unlikely to be sufficient alone to change treatment recommendations.
This is a Phase 1 registry record with no posted results; it describes a planned single-dose interventional study in a small sample (n=40) using surrogate endpoints (affect, pain catastrophizing, quantitative sensory testing) to explore mechanistic effects of psilocybin in a novel indication.
As stated by the source record.
Quoted from the source exactly as published.
This is a mechanistic Phase 1 trial and should not yet inform clinical practice. Results, when posted, may inform understanding of psilocybin's effects on pain and mood but are unlikely to be sufficient alone to change treatment recommendations.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06355414). This is a study registration, not published results. Lead sponsor: Johns Hopkins University. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Chronic Low-back Pain, Depression. Interventions: DRUG: Psilocybin; DRUG: Methylphenidate. Primary outcome measures: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) , 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete); Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) , 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete); Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) , 7-day period of EMA Post-drug Session (1-day through 1-week after drug session) relative to Baseline (beginning the day after baseline visit is complete); Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) , Baseline, 1-week follow-up. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.