PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study

NCT06666010 | Not Yet Recruiting Phase 2

• 1 other identifier: PATSUD_F
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Stimulant Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  3 Months

Secondary Outcomes (1)

• Number of AEs and SAEs

  3 Months

Study Arms (2)

Adult participants with confirmed StUD - Active

EXPERIMENTAL

PEX010 containing 25 mg psilocybin

Drug: PEX010-Assisted Therapy

Adult participants with confirmed StUD - Placebo

PLACEBO COMPARATOR

PEX010 containing 1 mg psilocybin

Drug: PEX010(01)

Interventions

PEX010-Assisted Therapy DRUG

The investigational medicinal product PEX010, containing 25 mg psilocybin, is a capsule for oral administration that contains the drug substance PYEX.

Adult participants with confirmed StUD - Active

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.

Adult participants with confirmed StUD - Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

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

Central Study Contacts

Lisa Ranken

CONTACT

250-212-1169; lisa@filament.health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 30, 2024

Record last verified: 2024-10