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

NCT06666010 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

  • Stimulant Use Disorder

Interventions

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.

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Filament Health Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2028-01-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666010 on ClinicalTrials.gov