Clinical TrialPsilocybinNot yet recruiting

Psilocybin-assisted therapy effects on non-prescribed opioid use and brain and cognitive health in people with Opioid Use Disorder engaged in opioid agonist treatment.

This randomised controlled parallel group Phase I trial (n=36) evaluated the safety and efficacy of psilocybin for opioid use disorder (oud).

Target Enrollment
36 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This study explores whether a single 30mg dose of Psilocybin - when given as part of Psychedelic-Assisted Therapy - can assist people who are living with Opioid Use Disorder reduce their use of non-prescribed opioids. The study will also use functional Magnetic Resonance Imaging (fMRI) to observe any changes in participants’ brain, thinking and mood.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Psilocybin

Participants

Inclusion Criteria

  • 1. Aged 18-60 inclusive.
  • 2. Meets DSM-5 criteria for Opioid Use Disorder, as assessed using QuickSCID-5.
  • 3. Have been on a MATOD program for at least 2 months prior to screening interview.
  • 4. Methadone/buprenorphine average daily dose (or equivalent weekly/monthly dose in the case of long-acting injectable buprenorphine) has varied by no more than 20% in the 2 weeks prior to screening interview.
  • 5. Willingness to remain on a stable dose of methadone/buprenorphine up to dosing day.
  • 6. Use of non-prescribed opioids more than 6 times on average across the 30-day period or at the judgement of the study clinician prior to screening interview.
  • 7. Have a breath alcohol concentration less than or equal to 0.01% at screening - this may be re-evaluated during the study period, at the judgement of the study clinician.
  • 8. Agree to refrain from non-prescribed psychotropic substance or illicit drug use for at least 72 hours prior to Psilocybin Dosing Session, with the exception of moderate use of alcohol, cannabis, nicotine, and caffeine.
  • 9. Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the Psilocybin Dosing Session unless approved by the study clinician.
  • 10. Are proficient in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
  • 11. Have the capacity to engage with, and consent to the study requirements and are able attend all study visits.
  • 12. Must consent to the study investigators contacting their primary treating health practitioner(s) for the purpose of corroborating medical history and their MATOD dosing pharmacy for the purpose of cross-validation of self-reported MATOD adherence.
  • 13. Have a family member or friend who can assist with transportation and activities of daily living after the Psilocybin Dosing Session.

Exclusion Criteria

  • 1. Currently pregnant, planning pregnancy, or breastfeeding.
  • 2. Participation in clinical trial and receipt of investigational drug(s) during 30 days prior to the research study, except as explicitly approved by the study clinician.
  • 3. Currently meets DSM-5 criteria for moderate to severe Substance Use Disorder (SUD) for substances other than opioids, alcohol, cannabis or nicotine. Patients with comorbid Alcohol Use Disorder (AUD) will be accepted if their AUD is not severe enough to require a medicated alcohol detoxification.
  • 4. Any use of serotonergic psychedelics in the past 6 months or more than 50 uses of any serotonergic psychedelics in lifetime.
  • 5. More than mild opioid withdrawal (COWS > 12).
  • 6. Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the capsule used in the study.
  • 7. Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms using standard medical interventions if necessary during or immediately after Psilocybin Dosing Session.
  • 8. Meets current or lifetime DSM-5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder, or has a first-degree family history of psychotic disorder. This includes hallucinogen-persistent perception disorder.
  • 9. Meets current or lifetime DSM-5 criteria for bipolar disorder or has first degree family history of bipolar disorder.
  • 10. Meets current DSM-5 criteria for severe Major Depressive Disorder (MDD); or current or lifetime DSM-5 criteria for MDD with psychotic features. Mild and moderate MDD as well as MDD in stable remission are allowed if no suicidal risk, in the clinical judgement of the study clinician.
  • 11. Have current serious suicide risk, as determined by responses to Columbia Suicide Severity Rating Scale (C-SSRS) and/or the clinical judgement of the study clinician or the treating team.
  • 12. Presence of any other psychiatric condition that, in the opinion of the study clinician, may interfere with completion of the study or place the patient at heightened risk.
  • 13. Have a history of or have a current medical condition which – based on the judgement of the study clinician - would make a participant unsuitable for the study. This includes, but is not limited to, the following:
  • a. Significant hepatocellular injury (except for patients with documented Gilberts syndrome)
  • b. Significant renal injury
  • c. Significant cardiovascular history/active cardiovascular conditions (e.g. high blood pressure, congenital long QT syndrome, coronary artery disease, cardiac ischemia, myocardial infarction, cardiac hypertrophy, congestive heart failure, tachycardia, ECG abnormalities, artificial heart valve)
  • d. Significant pulmonary illness (e.g. COPD)
  • e. Significant endocrine condition (e.g. insulin-dependent diabetes, hyperthyroidism)
  • f. Significant gastrointestinal illness (e.g. Crohn’s disease)
  • g. Seizure disorder or history of seizures not related to drug or alcohol withdrawal (excluding childhood febrile seizure)
  • h. History of serious head trauma or injury causing significant loss of consciousness and/or associate with skull fracture or intracranial bleeding or abnormal MRI
  • i. Current HIV infection
  • j. Weighs < 48kg or BMI < 17.
  • 14. Participants who present with contraindications to MRI scanning (including, but not limited to, magnetically active implants or devices, significant claustrophobia, or non-removable skin patches) may be excluded from participation in the MRI component of the study, as determined by the study clinician or radiologist.
  • 15. Has received medication that could interact adversely with psilocybin (e.g. inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase) within the time of administration of study agent, based on the guidance of the study clinician.
  • 16. Current use of psychoactive medications that in the study clinician’s judgement would meaningfully affect safety or effectiveness of trial medications (e.g. antipsychotics, mood stabilisers, stimulants). Antidepressants and PRN medications (e.g. short-acting benzodiazepines, z-drugs) may be permitted at the discretion of the study clinician, where safe and appropriate.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment36 participants
  • Timeline
    Start: 2025-12-19
    End: 2027-04-30
  • Compound
    Psilocybin

Locations

Unknown facility — Australia

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