Psilocybin in Chronic Low Back Pain and Depression

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06355414
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Drug administration under supportive conditions
  • Methylphenidate — DRUG
    Drug administration under supportive conditions

Study Details

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.

Key Dates

Start date
Apr 22, 2024
Status verified
Oct 2025
Primary completion
Jul 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin
    This arm will receive a single, absolute dose (25 mg) of psilocybin.
  • Active Comparator: Methylphenidate
    This arm will receive a single, absolute dose (40 mg) of methylphenidate.

Primary Outcome Measure

Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21224
David Yaden, PhD
[email protected]
410-550-5250
David Yaden, PhD (PRINCIPAL_INVESTIGATOR)
Patrick Finan, PhD (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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