Clinical TrialSubstance Use Disorders (SUD)PsilocybinRecruiting

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

This single-arm trial (n=15) aims to assess the safety, tolerability, and feasibility of using psilocybin (25mg) in combination with psychotherapy for methamphetamine use disorder.

Target Enrollment
15 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Pilot single-group Phase I study delivering three 90-minute preparatory psychotherapy sessions, one supervised 25 mg oral psilocybin dosing session (~8 hours), and two 60-minute integration sessions over a 4-week intervention period for participants with methamphetamine use disorder.

Outcomes include safety and tolerability (AEs per CTCAE v5.0), methamphetamine use by timeline followback and urine drug screening at baseline, dosing day, and days 1, 7, and 28 post-dose; adherence supported by session checklists and filming of dosing day.

Study Protocol

Preparation

3 sessions
90 min each

Dosing

1 sessions
480 min each

Integration

2 sessions
60 min each

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + therapy

experimental

Single-group psilocybin-assisted psychotherapy intervention for methamphetamine use disorder: preparatory sessions, a single supervised 25 mg psilocybin dosing session, and integration sessions.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral capsule administered 1–2 days after last preparatory session; supervised dosing day (~8 hours).

Participants

Ages
25 – 99
Sexes
Male & Female

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

Study Details

Locations

Unknown facility — Australia

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