Clinical TrialSubstance Use Disorders (SUD)KetamineCompleted

Ketamine-assisted psychotherapy for methamphetamine use disorder

This open-label, non-randomised Phase IV pilot (n=20) evaluates the safety and feasibility of manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weekly, weeks 2–4) for adults with methamphetamine use disorder.

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

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Related paper: Navigating ‘k-land’: a qualitative exploration of participants’ experiences of ketamine-assisted psychotherapy for methamphetamine use disorderCompound research: KetamineTopic research: Substance Use Disorders (SUD)

Detailed Description

Participants receive a manualised four-session CBT programme over four weeks with integration; three subcutaneous ketamine doses are administered once weekly in Weeks 2–4 with an escalation algorithm based on tolerability.

Ketamine dosing: initial 0.75 mg/kg SC, possible increase to 0.9 mg/kg if well tolerated; subsequent dosing adjusted to tolerability (range 0.5–0.9 mg/kg). Doses given by registered nurse under observation.

Safety is the primary focus: weekly clinic visits collect adverse events (KSET), vitals, dissociative effects, suicidality, and non-medical use liability; DSMB oversight. Outcomes include change in past 28-day methamphetamine use assessed weekly to Week 5 and at Weeks 8, 12 and 24.

Study Protocol

Preparation

1 sessions

Dosing

3 sessions

Integration

3 sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

KAP

experimental

Manualised 4-session CBT with three adjunctive subcutaneous ketamine doses (weeks 2–4) with dose-escalation based on tolerability.

Interventions

  • Ketamine0.75 - 0.9 mg/kg
    via Other• weekly• 3 doses total

    Subcutaneous ketamine HCl 200 mg/ml administered once weekly in Weeks 2–4. Dose escalation algorithm: Dose1 0.75 mg/kg; Dose2 increase to 0.9 mg/kg if well tolerated (or reduce to 0.75 or 0.6 if less tolerated); Dose3 range 0.5–0.9 mg/kg per tolerability. Direct observation by registered nurse.

Participants

Ages
18 – 98
Sexes
Male & Female

Inclusion Criteria

  • Adults presenting to outpatient drug treatment services seeking treatment for methamphetamine use disorder (MAUD) satisfying all of the following criteria:
  • Greater than or equal to 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 MINI
  • Urine drug screen (UDS) point-of-care test positive for methamphetamine
  • Seeking treatment to cease or reduce methamphetamine use
  • If of childbearing potential, willing to avoid pregnancy for study duration
  • Willing to register as a client of the St Vincent’s Hospital Sydney Stimulant Treatment Program (STP)

Exclusion Criteria

  • DSM-5-TR diagnosis of current or past use disorder for ketamine or ketamine analogues (MINI)
  • Prescribed or non-prescribed use of ketamine in the previous four weeks
  • Currently enrolled in another treatment trial of MAUD likely to affect safety/data quality or interfere with participation
  • Currently pregnant or breastfeeding, or planning pregnancy during study
  • DSM-5-TR diagnosis of current psychotic disorder (per PI and MINI)
  • Current acute suicidality defined as 'high risk' using the C-SSRS-6 screener or as determined by the PI
  • DSM-5-TR diagnosis of bipolar disorder (per PI and MINI)
  • Current DSM-5-TR diagnosis of other substance use disorders, moderate or severe (except tobacco, caffeine, or cannabis); opioid use disorder permitted if stable on opioid agonist treatment with stability requirements
  • History of sensitivity to ketamine or components of product
  • If prescribed antidepressants, must be on stable dose for ≥4 weeks
  • Contraindications to ketamine per Australian Product Information (severe cardiovascular disease, heart failure, severe/poorly controlled hypertension, recent MI, history of stroke, cerebral trauma, intracerebral mass/haemorrhage, etc.)
  • Any other medical or psychiatric condition making participation hazardous in PI opinion
  • Likely or planned surgery, travel, incarceration or other engagement interfering with participation

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2024-09-02
    End: 2025-12-30
  • Compound
    Ketamine
  • Topic
    Substance Use Disorders (SUD)

Locations

Unknown facility — Australia

Related Publications

Open AccessindividualPreliminary

Navigating ‘k-land’: a qualitative exploration of participants’ experiences of ketamine-assisted psychotherapy for methamphetamine use disorder

This qualitative study (n=14) explored how people with methamphetamine use disorder experienced ketamine-assisted psychotherapy and found that it was generally acceptable in a supportive setting. Participants described ketamine as creating a temporary state of reduced emotional and mental reactivity that seemed to help them engage with therapy, but changes in methamphetamine use were variable and depended on ongoing support and motivation.

Published
Journal
Frontiers in Psychiatry
Authors
Fletcher, K., Ezard, N., Siefried, K. J., van der Helder, S., Freestone, J., Brett, J., May, R., Acheson, L., Clifford, B.

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