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

This randomised, controlled trial (n=86) will assess the safety, feasibility, and efficacy of PEX010 (psilocybin) for the treatment of stimulant use disorder in adults. Participants will receive either a 25 mg dose of PEX010 or a 1 mg active placebo in conjunction with cognitive behavioural therapy.

The study involves two preparation sessions, one PEX010 dosing session, one integration session, and seven follow-up visits. The primary outcome measure is the reduction in stimulant use, assessed via the Timeline Followback method and urine drug tests over three months. Secondary outcomes include monitoring adverse events and serious adverse events.

The trial, sponsored by Filament Health Corp., is expected to start in January 2025 and complete in July 2028.

Topic Addiction Safety
Compound Psilocybin Placebo
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2025
End date 01 July 2028
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 86
Sex All
Age 19- 65
Therapy Yes

Trial Details

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.

Trial Number NCT06666010

Sponsors & Collaborators

University of British Columbia


Filament Health
Filament Health is a global extraction and drug discovery company. The company have a deep natural psychedelics IP portfolio and are led by an accomplished botanical extraction management team.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.