Wellcome Leap Psilocybin for OUD

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Anna Rose Childress, Ph.D.
Study ID
NCT06786325
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    PEX010 is the Psilocybin produced by Filament

Study Details

Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose.

Key Dates

Start date
Oct 7, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Oct 31, 2027

Study Design

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

Arms

  • Experimental: High Dose Psilocybin
    25 mg PEX010 capsule, single dose
  • Active Comparator: Low Dose Psilocybin
    1 mg PEX010 capsule, single dose

Primary Outcome Measure

Percent of patients in each arm having urine drug screens positive for opioids [ Time Frame: weeks 1 through 8 (outcomes phase) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Megan Ivey, MS
[email protected]
215-746-7712
Anna Rose Childress, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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