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.
The trial involves preparatory psychotherapy sessions, a single supervised dose of psilocybin (25mg), and post-psilocybin integration psychotherapy sessions over four weeks.
The primary outcomes include safety assessments for adverse events and feasibility measured by recruitment ratios and dropout rates. Secondary outcomes encompass measures of methamphetamine use, cravings, other illicit drug use, mental illness, quality of life, staffing costs, resting state brain network activity, changes in plasma biomarkers, and patient experiences through qualitative interviews.
Eligibility criteria include being aged 25 years and above, meeting DSM-5 criteria for methamphetamine use disorder, seeking treatment, and having a supportive environment post-dosing.
The study is conducted by St. Vincent’s Hospital, Sydney, funded by The National Centre for Clinical Research on Emerging Drugs (NCCRED), with A/Prof Jonathan Brett as the principal investigator. Recruitment started on 13/12/2022 and is ongoing in New South Wales, Australia. The trial hypothesizes that psilocybin psychotherapy for methamphetamine dependence can be safely and feasibly delivered from a public addiction outpatient clinic.
Trial Details
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.NCT Number ACTRN12622000463774