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

NCT06608459 | Not Yet Recruiting Phase 2

• 1 other identifier: PATOUD_F
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of AEs and SAEs

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

  8 weeks

Secondary Outcomes (1)

• Treatment retention

  8 weeks

Study Arms (1)

Adult participants with confirmed OUD

EXPERIMENTAL

Drug: PEX010-Assisted Therapy

Interventions

PEX010-Assisted Therapy DRUG

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

Also known as: PEX010

Adult participants with confirmed OUD

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• If they are a person able to become pregnant (PABP):
• 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
• Have a negative pregnancy test at screening and prior to each PEX010 session, and must agree to use adequate contraception through 10 days after the last PEX010 session. Adequate contraception methods include intrauterine devices, oral hormones plus barrier contraception, abstinence, injectable or implanted hormonal methods, or vasectomized/non-sperm carrying sole partner. Barrier methods alone are not considered effective methods of contraception.
• Be willing to refrain from caffeine for minimum 12 hours, cannabis and alcohol for minimum 24 hours and all other drugs for at least 5 days prior to PEX010 administration such that there are no clinical signs of intoxication or withdrawal
• Be able and willing to follow study procedure
• Be able to understand, communicate and speak English
• Complete the Columbia Suicide Severity Rating Scale (CSSRS)
• Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are within normal limits.

You may not qualify if:

• Are experiencing or at risk for significant withdrawal
• Have a history of overdose with opioids within the last 10 years
• Have any medical condition that would be contraindicated, including previously diagnosed conditions:
• 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);
• uncontrolled hypertension, resting blood pressure greater than 140/90 mmHg;
• baseline prolongation of QTc interval greater than 450 msec in both males and females;
• a history of major central nervous system disease (history of cerebrovascular accident, masses, aneurysm);
• a history of uncontrolled obstructive airway disease or significant respiratory compromise;
• a history of uncontrolled thyroid disease;
• a history of uncontrolled insulin dependent diabetes that may preclude safe participation in the study;
• a history of narrow-angle glaucoma;
• gastrointestinal conditions which may affect psilocybin absorption (i.e. stenosing peptic ulcer, pyloroduodenal obstruction);
• a history of active obstructive urological conditions (i.e. symptomatic prostatic hypertrophy, bladder-neck obstruction) that may preclude safe participation in the study.

Sponsors & Collaborators

• Filament Health Corp.: lead
• University of British Columbia: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Lisa Ranken

CONTACT

250-212-1169; lisa@filament.health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10