Stimulant Use DisorderPhase 2PATSUDNCT06666010
PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study
A Phase 2 study testing PEX010-Assisted Therapy and PEX010(01) in people with Stimulant Use Disorder, run by Filament Health Corp..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Stimulant Use Disorder
- What is being tested?
- PEX010-Assisted Therapy and PEX010(01)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jul 2028
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between 19 and 65 years old.
- Have signed the informed consent form for the study
- Have moderate to severe amphetamine stimulant use disorder (ASUD) as determined by the Mini-International Neuropsychiatric Interview (MINI 7.0.1), and clinical review by the study physician. The focus will be on illicit methamphetamine use.
- Are treatment-seeking but not currently receiving other treatments for SUD.
- Have stable housing.
- Have a local support person (close friend or family member) that is available to accompany them home from the study drug session.
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- Are of non-childbearing potential and/or using adequate contraception methods as defined by Health Canada.
- Non-childbearing potential is defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgical sterilization
- Have a negative pregnancy test at screening and prior to the study drug session. Must agree to use adequate contraception through 10 days after the study drug 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 ≥12 hours, cannabis and stimulants for ≥24 hours, and all other drugs for ≥5 days prior to PEX010 administration such that there are no clinical signs of intoxication or withdrawal.
- Able and willing to follow study procedure.
- Able to understand and communicate in 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 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 > 140/90 mmHg; baseline prolongation of QTc interval: >450 ms in both males and females;
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- 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 a personality disorder deemed to be high risk (antisocial, borderline, narcissistic) assessed via the SCID-5-PD.
- Have a personal history or family history of either mania/hypomania or psychosis, including substance-induced psychosis.
- Have any history of Hallucinogen Perception Disorder
- Have a history of suicide attempt within the last 6 years or a suicidal ideation in the last year.
- Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics)
- Are pregnant, breastfeeding, or not using adequate contraceptives if of childbearing potential.
- 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
- Have baseline heart rate outside of normal limits (e.g., >100 beats per minute).
- Subjects currently on medications with serotonergic activity, or taking inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.
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: A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study
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?
Read more
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.
Read the detailed description
In this randomized, controlled trial study participants will receive one capsule of PEX010 containing 25 mg or 1 mg of psilocybin, in conjunction with therapy.
Following screening and baseline visits, participants will receive 2 preparation sessions, 1 PEX010 dosing session, 1 integration session, and 7 follow-up visits.
- Conditions
- Stimulant Use Disorder
- Being tested
- PEX010-Assisted Therapy, PEX010(01)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX010-Assisted TherapyDrug
The investigational medicinal product PEX010, containing 25 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.
PEX010(01)Drug
The investigational medicinal product PEX010(01), containing 1 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.
| Study group | Role | What they receive |
|---|---|---|
| Adult participants with confirmed StUD - Active | Experimental | PEX010 containing 25 mg psilocybin Receives: Drug: PEX010-Assisted Therapy |
| Adult participants with confirmed StUD - Placebo | Placebo comparator | PEX010 containing 1 mg psilocybin Receives: Drug: PEX010(01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Amphetamine-type Stimulant Use
The difference between treatment and active placebo groups in the proportion of subjects abstinent from illicit methamphetamine use over the course of the 3-month assessment period assessed by Timeline Followback (TLFB) and urine drug tests (UDT).
Measured: 3 Months
Secondary outcomes (1)
Number of AEs and SAEs
Total number of adverse events (AEs) and serious adverse events (SAEs) reported during the 3-month assessment period.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 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
- NCT06666010
- Sponsor's protocol ID
- PATSUD_F
- Acronym
- PATSUD
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study
- ClinicalTrials.gov ID
- NCT06666010
- Acronym / sponsor ID
- PATSUD / PATSUD_F
- Conditions
- Stimulant Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Filament Health Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 Oct 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 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.
Detailed description
In this randomized, controlled trial study participants will receive one capsule of PEX010 containing 25 mg or 1 mg of psilocybin, in conjunction with therapy.
Following screening and baseline visits, participants will receive 2 preparation sessions, 1 PEX010 dosing session, 1 integration session, and 7 follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult participants with confirmed StUD - Active | Experimental | Drug: PEX010-Assisted TherapyPEX010 containing 25 mg psilocybin |
| Adult participants with confirmed StUD - Placebo | Placebo comparator | Drug: PEX010(01)PEX010 containing 1 mg psilocybin |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Are between 19 and 65 years old.
- Have signed the informed consent form for the study
- Have moderate to severe amphetamine stimulant use disorder (ASUD) as determined by the Mini-International Neuropsychiatric Interview (MINI 7.0.1), and clinical review by the study physician. The focus will be on illicit methamphetamine use.
- Are treatment-seeking but not currently receiving other treatments for SUD.
- Have stable housing.
Key exclusion criteria (23 listed)
- Are experiencing or at risk for significant withdrawal.
- 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);
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 TherapyThe investigational medicinal product PEX010, containing 25 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX. | Drug | Adult participants with confirmed StUD - Active |
| PEX010(01)The investigational medicinal product PEX010(01), containing 1 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX. | Drug | Adult participants with confirmed StUD - Placebo |
Primary outcome
Changes in Amphetamine-type Stimulant Use
Time frame: 3 Months
The difference between treatment and active placebo groups in the proportion of subjects abstinent from illicit methamphetamine use over the course of the 3-month assessment period assessed by Timeline Followback (TLFB) and urine drug tests (UDT).
1 secondary outcome
Number of AEs and SAEs
Time frame: 3 Months
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 30 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 and PEX010(01) in people with Stimulant 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 14 inclusion and 23 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 30 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. Some participants in this study may receive a placebo. 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?
Changes in Amphetamine-type Stimulant Use (time frame: 3 Months). 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 30 Oct 2024.