Wellcome Leap Psilocybin for OUD

This triple-blind, placebo-controlled trial (n=36) will study the effects of a single 25 mg dose of psilocybin (PEX010) on brain function, cognitive flexibility, and clinical outcomes in individuals receiving medication-assisted treatment (MAT) for opioid use disorder (OUD). Participants will be randomly assigned to receive either 25 mg or 1 mg of psilocybin in a 2:1 ratio.

The study, led by Dr. Anna Rose Childress at the University of Pennsylvania and sponsored by Wellcome Leap, aims to explore whether psilocybin can improve cognitive flexibility—the ability to adapt thoughts and behaviours—which is often impaired in people with OUD.

Researchers will investigate psilocybin’s impact on relapse rates, MAT adherence, and neurobiological markers linked to addiction. Participants will undergo brain and behavioural testing before and after the psilocybin session, with follow-ups continuing for one year. This study could provide insights into the potential of psychedelics to support addiction recovery by addressing cognitive and neural deficits.

Topic Addiction Opioid Use Disorder
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Planned
Results Published No
Start date 01 February 2025
End date 01 October 2027
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 36
Sex All
Age 18- 60
Therapy Yes

Trial Details

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.

Trial Number NCT06786325

Data attribution

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