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.
Are between 19 and 65 years old.
Have signed the informed consent form for the study
Have moderate to severe amphetamine stimulant use disorder (ASUD) as determined by the Mini-International Neuropsychiatric Interview (MINI 7.0.1), and clinical review by the study physician. The focus will be on illicit methamphetamine use.
Are treatment-seeking but not currently receiving other treatments for SUD.
Are experiencing or at risk for significant withdrawal.
seizure disorder or history of seizures;
a history of significantly impaired hepatic function;
a history of unstable or uncontrolled cardiovascular disease (coronary artery disease, heart failure, clinically significant ECG abnormality);
Parallel
PEX010-Assisted Therapy
DrugThe investigational medicinal product PEX010, containing 25 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.
PEX010(01)
DrugThe investigational medicinal product PEX010(01), containing 1 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.
Changes in Amphetamine-type Stimulant Use
The difference between treatment and active placebo groups in the proportion of subjects abstinent from illicit methamphetamine use over the course of the 3-month assessment period assessed by Timeline Followback (TLFB) and urine drug tests (UDT).
Number of AEs and SAEs
Total number of adverse events (AEs) and serious adverse events (SAEs) reported during the 3-month assessment period.
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Filament Health Corp.
Lead sponsor
University of British Columbia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
