Clinical TrialSubstance Use Disorders (SUD)KetamineRecruiting

Ketamine-assisted psychotherapy for methamphetamine use disorder

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

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

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

  • Compound
    via Other• four sessions over 4 weeks• 4 doses total

    Manualised CBT (Baker et al. 2003). Sessions ~90 minutes each; session 1 assessment and motivational interviewing; sessions 2–4 include brief integration within 24–48 hours of ketamine dosing; optional 1‑hour booster at week 6.

  • 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 Details

  • Status
    Recruiting
  • 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

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