Psilocybin on Brain Mechanisms of Motivation in OUD

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06810310
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 (high dose) — DRUG
    PEX010 is the psilocybin produced by Filament
  • psilocybin (low dose) — DRUG
    1mg psilocybin, produced by Filament

Study Details

The goal of this study is to test addiction-related brain circuitry (motivation/reward and inhibition) as well as neurocognitive circuitry prior to and following low or high dose psilocybin (PEX010 from Filament). Using fMRI, we will examine brain circuits relevant to drug relapse as well as neurocognitive flexibility circuits in individuals with opioid use disorder. We will randomize 24 males and females, aged 18 - 60, in the greater Philadelphia area, to either 1mg or 25 mg of psilocybin. Participants will come to our offices for screening visits - these are assessments, interviews, and some medical tests (such as a history and physical, as well as a fasting blood draw) to help us determine eligibility for our study. If eligible, they will be brought to our offices at 3535 Market Street in Philadelphia for about 7 visits. These visits include pre-dose psilocybin preparation therapy, baseline assessments and neuropsychological testing, psilocybin dosing, post dose therapy visits, and post dose assessments.

Key Dates

Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Low dose psilobyin
    1 mg PEX010 capsule, single dose
  • Experimental: High dose psilocybin
    25 mg PEX010 capsule, single dose

Primary Outcome Measure

Brain measure of GO domain [ Time Frame: One week pre dose and one week post dose ]

Central Contacts

Locations (1)

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

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