Opioid Use DisorderPhase 2NCT06608459
PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
A Phase 2 study testing PEX010-Assisted Therapy in people with Opioid Use Disorder, run by Filament Health Corp..
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PEX010-Assisted Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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);
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- 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.
- Have any mental health disorder that would be contraindicated, including previously diagnosed or suspected mania/hypomania or psychosis as determined by the Modified MINI 7.0.1
- Have a first- or second-degree relative with psychotic or bipolar disorder
- Have a personality disorder deemed to be high risk (antisocial, borderline, narcissistic) assessed via the SCID-5-PD.
- Have a history of suicide attempt within the last 10 years or a suicidal ideation in the last year
- Have used any illicit stimulants or more than 3 drinks per week of alcohol in past 30 days
- Have used classic psychedelic drugs (e.g. psilocybin, LSD, DMT, ayahuasca, or mescaline) in the last 12 months or more than 25 times in lifetime, based on self-report
- Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics)
- Are pregnant, breastfeeding, or they are a PABP and not practicing an adequate form of birth control
- Any other finding(s) based on the screening process that the investigator determines makes the candidate unsuitable for the study
- Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are not within normal limits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Open-Label, Single Arm Study of PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
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
Read the detailed description
In this open-label study participants will receive PEX010, standardized to contain 25mg or 35 mg psilocybin, in conjunction with therapy. An open-label design was chosen given the novelty of this approach in treating OUD and high risk associated with opioid use.
Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.
- Conditions
- Opioid Use Disorder
- Being tested
- PEX010-Assisted Therapy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX010-Assisted TherapyDrug
Also called PEX010
The investigational medicinal product PEX010 is a capsule for oral administration that contains the drug substance PYEX.
| Study group | Role | What they receive |
|---|---|---|
| Adult participants with confirmed OUD | Experimental | Not described Receives: Drug: PEX010-Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of AEs and SAEs
Total number of adverse events (AEs) and serious adverse events (SAEs) reported during the 8-week study period.
Measured: 8 weeks
Secondary outcomes (1)
Treatment retention
Percentage and number of participants who complete follow-up assessments.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filament Health Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608459
- Sponsor's protocol ID
- PATOUD_F
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single Arm Study of PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
- ClinicalTrials.gov ID
- NCT06608459
- Acronym / sponsor ID
- PATOUD_F
- Conditions
- Opioid Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Filament Health Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
In this open-label study participants will receive PEX010, standardized to contain 25mg or 35 mg psilocybin, in conjunction with therapy. An open-label design was chosen given the novelty of this approach in treating OUD and high risk associated with opioid use.
Following screening and baseline visits, participants will receive 3 preparation sessions with psychotherapy, 2 PEX010 sessions, 2 integration sessions with psychotherapy, and 3 follow-up visits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult participants with confirmed OUD | Experimental | Drug: PEX010-Assisted Therapy |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEX010-Assisted TherapyAlso: PEX010The investigational medicinal product PEX010 is a capsule for oral administration that contains the drug substance PYEX. | Drug | Adult participants with confirmed OUD |
Primary outcome
Number of AEs and SAEs
Time frame: 8 weeks
Total number of adverse events (AEs) and serious adverse events (SAEs) reported during the 8-week study period.
1 secondary outcome
Treatment retention
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEX010-Assisted Therapy in people with Opioid Use Disorder, run by Filament Health Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Ranken (250-212-1169, lisa@filament.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of AEs and SAEs (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.