Actively Recruiting
Psilocybin on Brain Mechanisms of Motivation in OUD
Led by Anna Rose Childress, Ph.D. · Updated on 2025-12-29
24
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 1. 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. 2. If not already in an inpatient setting, participants be admitted to an inpatient program for the duration of the psilocybin phases - about two weeks. During this time, 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.
CONDITIONS
Official Title
Psilocybin on Brain Mechanisms of Motivation in OUD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Voluntary enrollment in a residential addiction treatment facility
- Intend to stay in the residential facility during psilocybin dosing period
- Stable buprenorphine (BUP-NX) prescription for at least one week and plan to continue for 12 weeks, or received Sublocade injection within past month, or on consistent methadone maintenance therapy for at least one week with positive urine test
- Physically healthy males and females aged 18-60 years with opioid use disorder as primary diagnosis
- Females must be non-pregnant, non-lactating, and agree to use contraception 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 without approval
- Moderate to severe substance use disorder for substances other than cocaine, alcohol, marijuana, or nicotine; prior psilocybin use excluded
- Current or lifetime diagnosis of schizophrenia, psychotic disorders, organic mental disorders, or first-degree family history of these
- Current diagnosis of bipolar disorder
- Severe major depressive disorder; mild, moderate, or stable remission allowed without suicidal risk or antidepressant use
- Significant trauma with elevated PTSD symptoms as judged by investigator
- Other psychiatric disorders interfering with study or safety
- Active suicidal thoughts or serious suicide attempt history
- Significant liver, lung, endocrine, heart, kidney, gastrointestinal disease, or current HIV infection
- Serious head trauma with prolonged unconsciousness or abnormal MRI
- Seizure disorder unrelated to withdrawal
- Presence of magnetic implants or devices unless deemed safe
- Claustrophobia or inability to lie in MRI for 60 minutes
- Non-removable skin patches as judged by investigator
- Medications that may interact adversely with psilocybin
- Need for psychoactive medications except limited use of Benadryl
- Cardiovascular conditions including coronary artery disease, long QT syndrome, cardiac hypertrophy, ischemia, heart failure, prior heart attack, tachycardia, ECG abnormalities, artificial heart valve, or other significant heart issues
- Elevated blood pressure above defined limits at screening or baseline
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Anna Rose Childress, PhD
CONTACT
M
Megan Ivey, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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