Actively Recruiting
Wellcome Leap Psilocybin for OUD
Led by Anna Rose Childress, Ph.D. · Updated on 2025-10-29
36
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Wellcome Leap Psilocybin for OUD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Voluntary enrollment in a residential addiction treatment facility
- Intend to stay in the residential facility during pre- and post-psilocybin dosing periods
- On stable methadone or buprenorphine treatment with positive urine test for the medication
- Aged 18 to 60 years
- Diagnosed with opioid use disorder based on DSM-5 criteria
- Females must be non-pregnant, non-lactating, and use birth control if of childbearing potential
- Able to read, speak, understand, and write English at or above eighth-grade level
- IQ score of 80 or higher
You will not qualify if you...
- Participation in another clinical trial with investigational drugs within 30 days
- Moderate to severe substance use disorder for substances other than cocaine, alcohol, marijuana, or nicotine
- Diagnosis or family history of schizophrenia, psychotic disorders, or organic mental disorders
- Current bipolar disorder diagnosis
- Severe major depressive disorder or active suicidal ideation
- Significant trauma with elevated PTSD symptoms
- Other psychiatric disorders interfering with study participation
- Significant active hepatitis, liver injury, or serious heart, lung, kidney, or gastrointestinal disease
- History of serious head trauma or abnormal brain MRI
- Seizure disorder unrelated to withdrawal
- Presence of magnetic implants or other MRI contraindications
- Claustrophobia or inability to lie still for MRI
- Use of medications that interact with psilocybin
- Need for psychoactive medication except occasional Benadryl
- Cardiovascular conditions including coronary artery disease, long QT syndrome, cardiac hypertrophy, ischemia, heart failure, myocardial infarction, tachycardia, ECG abnormalities, or artificial heart valve
- Elevated blood pressure above specified limits on multiple readings
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Megan Ivey, MS
CONTACT
P
Paul Regier, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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