Skip to main content
. 2025 Feb 10;15(2):e092504. doi: 10.1136/bmjopen-2024-092504

Table 1. Eligibility criteria.

Inclusion criteria Exclusion criteria
All participants must/must be: All participants must not:
  • ≥18 years of age

  • Able to provide informed consent

  • Willing and able to comply with all study requirements, as determined by the principal investigator

  • Meets DSM-5-TR diagnostic criteria for current stimulant use disorder—amphetamine-type substance—as determined by the principal investigator and confirmed with the MINI

  • Urine drug screen (UDS) point of care (POC) test positive for methamphetamine

  • Willing to register as a client of the St Vincent’s Hospital Sydney (SVHS) Stimulant Treatment Programme (STP)

  • DSM-5-TR diagnosis of current or past use disorder for ketamine or ketamine analogues as assessed by MINI

  • Prescribed or non-prescribed use of ketamine in the previous 4 weeks

  • Currently enrolled in another treatment trial of MAUD or clinical trial which is likely to affect safety, data quality or may interfere with participation in this study, as determined by the principal investigator

  • Currently pregnant or breastfeeding, or planning on becoming pregnant during the course of the study

  • DSM-5-TR diagnosis of current psychotic disorder as assessed by the principal investigator including review of MINI

  • Current acute suicidality defined as ‘high risk’ using the C-SSRS-6 screener or as determined by the principal investigator

  • DSM-5-TR diagnosis of bipolar disorder as assessed by the principal investigator including review of MINI

  • Current DSM-5-TR diagnosis with other substance use disorders, moderate or severe, except tobacco, caffeine or cannabis as assessed by the principal investigator including review of MINI. Opioid use disorder permitted if stable on opioid agonist treatment; OAT) (ie, no dose changes for 6 weeks if on oral OAT and maximum of one missed dose/week. At least 3 months with no missed doses if on long-acting injectable OAT)

  • History of sensitivity to ketamine or any other components of this product

  • If prescribed antidepressants, the participant must have been on a stable dose for four or more weeks

  • Contraindications to ketamine according to Australian Product Information:

    • Severe cardiovascular disease

    • Heart failure

    • Severe or poorly controlled hypertension

    • Recent myocardial infarction

    • History of stroke

    • Cerebral trauma

    • Intracerebral mass or haemorrhage

  • Seeking treatment to cease or reduce methamphetamine use

  • If person of childbearing potential, willing to avoid pregnancy for study duration

  • Any other medical or psychiatric condition which in the opinion of the principal investigator would make participation hazardous. In particular, caution if severe liver, kidney or bladder disease, and also caution if elevated cerebrospinal fluid pressure, increased intraocular pressure, acute intermittent porphyria, seizures, hyperthyroidism, pulmonary or upper respiratory infection, intracranial mass lesions, a presence of head injury, globe injuries, or hydrocephalus

  • Likely or planned surgery, travel, incarceration or other engagement during the study that may interfere with study participation

MAUDmethamphetamine use disorder