Clinical TrialSubstance Use Disorders (SUD)KetaminePlaceboRecruiting

Ketamine for Methamphetamine Use Disorder (KMD)

This randomised, double-blind, placebo-controlled trial (n=120) will study the efficacy of intravenous (IV) ketamine versus IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD).

Target Enrollment
120 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

This is a 12-week randomised, triple-blind, parallel-group trial comparing IV ketamine (0.50 mg/kg) to IV midazolam (0.02 mg/kg) delivered as eight infusions over six weeks in adults with moderate to severe methamphetamine use disorder.

All participants receive weekly medical management during weeks 1–6 and weekly cognitive behavioural therapy on non-infusion days for 12 weeks; outcomes include feasibility, safety, and efficacy to inform larger multi-site trials.

Study Protocol

Preparation

6 sessions

Dosing

8 sessions
45 min each

Integration

12 sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine

experimental

IV ketamine infusions (0.50 mg/kg) administered 8 times over 6 weeks.

Interventions

  • Ketamine0.5 mg/kg
    via IV• 8 infusions over 6 weeks• 8 doses total

    Infusions administered over ~45 minutes in 100 mL 0.9% sodium chloride; duration may be extended by clinician.

Midazolam

active comparator

IV midazolam infusions (0.02 mg/kg) administered 8 times over 6 weeks as active comparator.

Interventions

  • Placebo0.02 mg/kg
    via IV• 8 infusions over 6 weeks• 8 doses total

    Midazolam (Versed) 0.02 mg/kg dissolved in 0.9% sodium chloride; encoded as active comparator (compound set to placebo reference)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria
  • Study participants must:
  • 1. Be 18 to 65 years old
  • 2. Be able to sufficiently understand, speak, and read English
  • 3. Be interested in reducing or stopping methamphetamine use
  • 4. Meet criteria for methamphetamine use disorder
  • 5. Use acceptable methods of contraception during participation in the study

Exclusion Criteria

  • Exclusion criteria
  • Study participants must not:
  • 1. Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
  • 2. Be currently in jail, prison, or inpatient overnight facility as required by court of law
  • 3. Have upcoming surgery planned or scheduled
  • 4. Be currently pregnant, breastfeeding, or planning on conception, if biologically female
  • Additional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.

Study Details

Locations

Interdisciplinary Substance Use and Brain Injury Facility — Albuquerque, New Mexico, United States
Addiction Institute of Mount Sinai — New York, New York, United States
Prisma Health — Greenville, South Carolina, United States
UT Southwestern Medical Center — Dallas, Texas, United States

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