CompletedPhase 1ACTRN12622000463774

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

Safety, tolerability, and feasibility of psilocybin-facilitated treatment for methamphetamine use disorder: A pilot study (Psi-MA): A pilot study (Psi-MA)

Sponsor

St. Vincent's Hospital, Sydney

Enrollment

15 participants

Start Date

Dec 13, 2022

Study Type

Interventional

Conditions

Methamphetamine Use Disorder

Summary

This is a single centre, single arm, study primarily examining the safety and feasibility of psychotherapy combined with a single dose of 25mg psilocybin. Study Hypothesis: That psilocybin psychotherapy for methamphetamine dependence can be safely and feasibly delivered from a public addiction outpatient clinic.

Eligibility

Sex: Both males and femalesMin Age: 25 Yearss

Inclusion Criteria12

· 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 Criteria19

· 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:
o History of any drug induced psychosis or any psychotic disorder or psychotic episode
o History of bipolar I or II disorder
o History of anorexia nervosa or bulimia nervosa
o First or second-degree relatives with history of any psychotic disorders, or bipolar I or II disorders
o Current 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

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Interventions

1. Three 90 minute preparatory psychotherapy sessions over two weeks facilitated by dyad of trained clinical psychologists and psychiatrist; includes alliance building, intention setting, psychoeducation and non-avoidance training. 2. Psilocybin one 25mg oral capsule within 1-2 days of the last preparatory psychotherapy session; dosing session facilitated by same therapist dyad over 8 hours following the single supervised dose. 3. Two 60 minute post-psilocybin integration psychotherapy sessions facilitated by same therapist dyad; first session within 1 week of psilocybin dosing and second the following week. Intervention occurs over 4 weeks. Adherence to intervention ensured by session checklists and filming of dosing day.