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
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
Treatments tested in this trial
- PEX010-Assisted Therapy
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Filament Health Corp.
Lead sponsor
University of British Columbia
Collaborator
Source ClinicalTrials.gov