Clinical TrialSubstance Use Disorders (SUD)KetamineRecruiting

MethAmphetamine use in young people: safety and tolerability of Sub-anaesthetic Ketamine, An Open-label Trial

This open-label Phase II pilot study (n=20), registered on ANZCTR with the trial acronym MASKOT, investigates the safety and tolerability of sub-anaesthetic ketamine in young people with methamphetamine use disorder seeking treatment to reduce their methamphetamine use.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase II pilot (n=20) assessing safety and tolerability of sub-anaesthetic ketamine administered subcutaneously once weekly for two sessions in young people (15–35 years) with methamphetamine use disorder. Dose starts at 0.75 mg/kg (Level 1) with escalation to 0.9 mg/kg (Level 2) after ≥7 days if tolerated; dose may be reduced to 0.6 mg/kg (Level 0) for the second dose if initial dose not tolerated.

Primary outcome is safety, indexed by change from baseline in average past-month occasions of ketamine use (Timeline Follow Back). Secondary outcomes include change in ketamine craving (Brief Substance Craving Scale) with assessments at baseline and Weeks 1, 2, 3, 4 and 6 post-intervention.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine SC

experimental

Subcutaneous low-dose ketamine once weekly for two sessions with possible escalation or reduction based on tolerability.

Interventions

  • Ketamine0.75 mg/kg
    via Other• weekly• 2 doses total

    Level 1 0.75 mg/kg; Level 2 0.9 mg/kg if tolerated after ≥7 days; Level 0 0.6 mg/kg if Level 1 not tolerated; administered subcutaneously by clinician.

Participants

Ages
15 – 35
Sexes
Male & Female

Inclusion Criteria

  • 15–35 years inclusive at consent;
  • Current stimulant use disorder – methamphetamine type, moderate or severe, assessed using the Structured Clinical Interview for DSM-5 (SCID-5);
  • Current methamphetamine use, indicated by positive urine toxicology (qualitative) at 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;
  • Ability to provide informed consent (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;
  • Current DSM-5 diagnosis with other substance use disorders, moderate or severe, except tobacco, caffeine, or cannabis.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2022-03-10
    End: 2023-02-28
  • Compound
    Ketamine
  • Topic
    Substance Use Disorders (SUD)

Locations

Unknown facility — Australia

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