NCT06608459

PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study

Open-Label, Single Arm Study of PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Filament Health Corp. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010. The main questions it aims to answer are: Can we successfully recruit participants, provide the drug and retain participants for the duration of the study? What medical problems do participants experience when taking PEX010? Participants will: Take PEX010 twice during the study Engage in cognitive behavioural therapy Visit the clinic once or twice per week for study intervention and followup visits

Detailed description

In this open-label study participants will receive PEX010, standardized to contain 25mg or 35 mg psilocybin, in conjunction with therapy. An open-label design was chosen given the novelty of this approach in treating OUD and high risk associated with opioid use. Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	PEX010-Assisted Therapy	The investigational medicinal product PEX010 is a capsule for oral administration that contains the drug substance PYEX.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-09-23
• Last updated: 2024-10-17