A Wellcome Leap for the Opioid Crisis: Can the 5HT2A Agonist Psilocybin Improve Brain, Behavioral, and Clinical Outcomes in Opioid Use Disorder (OUD)?
Anna Rose Childress, Ph.D.
Summary
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.
Description
The Opioid Crisis: Currently in its third wave, the opioid epidemic involves the prevalence of lethal levels of fentanyl in drugs, leading to a surge in opioid-related deaths. Reports indicate a record-breaking number of over 107,000 drug-related overdose deaths in 2021-2022, with opioids contributing to more than 75% of these fatalities. Beyond fatal overdoses, nearly 1 million non-fatal overdoses occurred in 2017, carrying significant, long-lasting consequences. Those who experience non-fatal overdoses are more prone to subsequent overdoses and have a higher likelihood of death within a year…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * An informed consent document voluntarily signed and dated by the subject. * Voluntary enrollment in the residential addiction treatment facility * Intention on residing within residential addiction treatment facility for the duration of the Pre/Post PSI dosing period. * Either 1) have a confirmed prescription for BUP-NX in a drug monitoring program database, have been on a stable dose of BUP-NX for at least one week, and plan to continue taking BUP-NX for at least 12 weeks or 2) have received an injection of Sublocade® within the past month, or 3) are currently on methad…
Interventions
- DrugPsilocybin
PEX010 is the Psilocybin produced by Filament
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania