Psilocybin-facilitated treatment for methamphetamine Use Disorder: A pilot study (Psi-MA)

Phase 1

Completed

• Conditions: Methamphetamine Use Disorder; Mental Health - Addiction

• Registration Number: ACTRN12622000463774
• Lead Sponsor: St. Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-24
• Study Completion: 2024-03-01
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

·Aged 25 years and above
·Meet DSM-5 criteria for methamphetamine use disorder (MAUD) as determined by an Addiction Specialist
·Used MA on less than 16 out of the prior 28 days
·Currently seeking treatment for methamphetamine use disorder
·Have at least one urine drug screen positive for methamphetamine within 1 month of trial registration
·Ability to read/write in English
·Availability of a friend or family member into whose care the participant can be released following their drug administration session for the subsequent 24 hours
·Home-like environment in which to be cared for the 24 hours following psilocybin dosing
·In good general health as assessed by detailed medical history and physical examination
·Abstinence from methamphetamine, other illicit drugs (including extra-medical use of opioids and benzodiazepines), and alcohol for at least 2 days prior to psilocybin administration as confirmed via urinalysis and no signs of intoxication or withdrawal on the day of psilocybin administration
·Good engagement with psychotherapy team at pre-psilocybin psychotherapy session immediately prior to psilocybin dosing session, and consensus on good alliance from both therapists.
·Can swallow pills

Exclusion Criteria

·Women who are pregnant or breast feeding or of childbearing potential and not willing to avoid becoming pregnant during the study
·Medically significant condition which, in the opinion of the investigator would render a patient unsuitable for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc).
·Current hypertension uncontrolled by a single antihypertensive (exceeding 140 mmHg systolic and 90 mmHg diastolic after 15 minutes of rest, averaged across four assessments on at least two separate days.)
·History of psychiatric illness other than substance use disorder that is severe within the last 5 years as assessed by a psychiatrist, or any other condition that may compromise patient safety as assessed by psychiatrist
·Current use of antidepressant medication, specifically monoamine oxidase inhibitors, antipsychotic medications, St. John's Wort, or other medications as determined by the study psychiatrist
·Any of the following on clinical interview with a psychiatrist:
oHistory of any drug induced psychosis or any psychotic disorder or psychotic episode
oHistory of bipolar I or II disorder
oHistory of anorexia nervosa or bulimia nervosa
oFirst or second-degree relatives with history of any psychotic disorders, or bipolar I or II disorders
oCurrent suicidal or homicidal ideation
·History of any other illicit drug, illicit or prescribed benzodiazepine use extra-medical use of opioids within the 2 days preceding psilocybin administration. People receiving opioid substitution therapy who otherwise meet the eligibility criteria may be included.
·History of alcohol use disorder within the preceding 3 months
·History of cannabis use disorder within the preceding 3 months
·Use of a classical hallucinogen (LSD, DMT, psilocybin, mescaline, salvia divinorum, ibogaine) within the preceding 28 days.
·Planning to move from the Sydney area in the next 6 months or any other reason precluding follow up in this time period (e.g. likely travel or imprisonment)
·Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)
·Unstable housing or homeless
·Inability to attend all screening visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessed as adverse events (e.g. sweating, nausea, vomiting) on participant self-report, documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0)'[ Assessed from recruitment at the following time points: <br>Each of the 3 preparatory psychotherapy sessions<br>Psilocybin dosing day<br>Days 1, 7, and 28 days post psilocybin dose];Feasibility: Measured by ratios of screened to recruited and drop out rate[ Assessed daily from the point of screening to 28 days post psilocybin dose]