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

ConditionOpioid Use Disorder

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age25-55

SponsorFilament Health Corp.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a confirmed moderate to severe opioid use disorder as determined by the Mini-International Neuropsychiatric Interview (MINI), and the study physician assessment

Have stable housing

Have a local support person (close friend or family member) that is available to accompany them home

Be of non-childbearing potential, defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and 45 years of age or older); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or

Disqualifiers

Are experiencing or at risk for significant withdrawal

Have a history of overdose with opioids within the last 10 years

seizure disorder or history of seizures;

a history of significantly impaired hepatic function;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Adult participants with confirmed OUDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of AEs and SAEs

Total number of adverse events (AEs) and serious adverse events (SAEs) reported during the 8-week study period.

Time frame

8 weeks

Secondary outcomes

Treatment retention

Percentage and number of participants who complete follow-up assessments.

Time frame

8 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Filament Health Corp.

Lead sponsor

University of British Columbia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: