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NCT06810310 · ClinicalTrials.gov registry record · Phase 2
Psilocybin on Brain Mechanisms of Motivation in OUD
A Phase 2 study of Opioid Use Disorder, sponsored by Anna Rose Childress, Ph.D..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06810310 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Anna Rose Childress, Ph.D.. The registered enrollment target is 24 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06810310, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Anna Rose Childress, Ph.D..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Psilocybin (high dose)
- DRUG psilocybin (low dose)
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06810310
The ClinicalTrials.gov registry entry for NCT06810310 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Anna Rose Childress, Ph.D., which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Psilocybin (high dose) is the first listed.
NCT06810310 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06810310 about?
NCT06810310 is a clinical study titled "Psilocybin on Brain Mechanisms of Motivation in OUD". 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 neuroco...
What is the current status of trial NCT06810310?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2025-12-22. Estimated completion is 2026-05-01.
What conditions does trial NCT06810310 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06810310?
The interventions under investigation include: Psilocybin (high dose) (DRUG), psilocybin (low dose) (DRUG).
Who is sponsoring clinical trial NCT06810310?
This trial is sponsored by Anna Rose Childress, Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06810310 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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