None listed
Conditions
Brief summary
This is an open-label Phase II pilot study to investigate the safety and tolerability of two doses of ketamine in young people with stimulant use disorder, methamphetamine-type seeking treatment to reduce their methamphetamine use. The study treatments will be provided in addition to treatment-as-usual received by participants during their regular clinical care. All participants will be engaged with a GP or psychiatrist, either through headspace, Orygen, or in the community, and they will be offered referral into outpatient alcohol and other drug treatment at headspace or in the community. They will receive psychiatric and medical review by the study doctor during screening and at weeks 1 and 2. Participants will complete comprehensive screening and baseline testing. They will then undergo two ketamine administration sessions (subcutaneous; initial dose 0.75 mg/kg) separated by at least 7 days. Assessments will occur at baseline and weeks 2, 3, 4, and 6.
Interventions
Low-dose ketamine, administered subcutaneously by a study clinician (medical doctor or nurse) once a week for 2 weeks. The starting dose (Level 1) of ketamine is 0.75mg/kg, followed by the second dose (0.9mg/kg; Level 2) after at least 7 days, if participants are able to tolerate the initial dose without clinically significant discomfort. Those who are unable to tolerate the starting dose (Level 1) will have their dosage reduced to 0.6mg/kg (Level 0) for the second dose administration. Medicatio
Low-dose ketamine, administered subcutaneously by a study clinician (medical doctor or nurse) once a week for 2 weeks. The starting dose (Level 1) of ketamine is 0.75mg/kg, followed by the second dose (0.9mg/kg; Level 2) after at least 7 days, if participants are able to tolerate the initial dose without clinically significant discomfort. Those who are unable to tolerate the starting dose (Level 1) will have their dosage reduced to 0.6mg/kg (Level 0) for the second dose administration. Medication administration and missed administration sessions will be recorded on study documentation.
Sponsors
Orygen National
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
• 15-35 years old inclusive at consent; • Current stimulant use disorder – methamphetamine type, moderate or severe, assessed using the Structured Clinical Interview for DSM-5; • Current methamphetamine use, indicated by positive urine toxicology (qualitative) for methamphetamine use at either screening or baseline visits; • Engaged with a regular treating doctor (general practitioner or psychiatrist); • Ability to comply with the study protocol, as determined by the CI; and • Ability to provide informed consent (both adequate IQ and English fluency; 15 to 17 year olds will provide consent themselves, as will a parent/guardian).
Exclusion criteria
• History of psychosis or bipolar disorder (other than transient drug-related symptoms) assessed with the SCID-5; • Acute suicidality, based on clinical judgement by the study doctor or other qualified clinician); • If female, pregnancy or current breastfeeding, or, if sexually active, no effective contraception; • Abnormal liver or thyroid function as indicated by clinically significant findings on blood tests; • If prescribed antidepressants, the participant must have been on a stable dose for >2 weeks; • Current treatment with antipsychotic medication, mood stabiliser, or ADHD medication; • Participation in another trial, which is likely to affect safety or data quality for this study, as determined by the CI; • Any unstable medical or neurological condition, or medical contraindication to ketamine use, e.g. uncontrolled hypertension; • Current or past DSM-5 diagnosis with ketamine use disorder, moderate or severe; and • Current DSM-5 diagnosis with other substance use disorders, moderate or severe, except tobacco, caffeine, or cannabis.
Outcome results
None listed