| 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)
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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
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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
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Seeking treatment to cease or reduce methamphetamine use
If person of childbearing potential, willing to avoid pregnancy for study duration
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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
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