NCT06666010

PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study

A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Filament Health Corp. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX010? Researchers will compare an active PEX010 dose containing 25 mg psilocybin to an active placebo arm, to see if PEX010 works to reduce stimulant use. Participants will: Take PEX010 or the active placebo once during the study, engage in cognitive behavioural therapy, and visit the clinic twice weekly for study intervention and follow-up assessments.

Detailed description

In this randomized, controlled trial study participants will receive one capsule of PEX010 containing 25 mg or 1 mg of psilocybin, in conjunction with therapy. Following screening and baseline visits, participants will receive 2 preparation sessions, 1 PEX010 dosing session, 1 integration session, and 7 follow-up visits.

Conditions

• Stimulant Use Disorder

Interventions

Type	Name	Description
DRUG	PEX010-Assisted Therapy	The investigational medicinal product PEX010, containing 25 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.
DRUG	PEX010(01)	The investigational medicinal product PEX010(01), containing 1 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2024-10-30
• Last updated: 2024-10-30