Ketamine for Methamphetamine Use Disorder
NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
University of Texas Southwestern Medical Center
120 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
Summary
This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD. The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).
Eligibility
Inclusion Criteria6
- Study participants must:
- Be 18 to 65 years old
- Be able to sufficiently understand, speak, and read English
- Be interested in reducing or stopping methamphetamine use
- Meet criteria for methamphetamine use disorder
- Use acceptable methods of contraception during participation in the study
Exclusion Criteria5
- Study participants must not:
- Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
- Be currently in jail, prison, or inpatient overnight facility as required by court of law
- Have upcoming surgery planned or scheduled
- Be currently pregnant, breastfeeding, or planning on conception, if biologically female
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Interventions
Participants will receive IV ketamine (0.50mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump over 45 minutes. Duration of each infusion may be extended by the Study Clinician supervising study medication infusion if slower infusion rate is better tolerated.
Participants will receive IV midazolam (0.02mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump over 45 minutes. Duration of each infusion may be extended by the Study Clinician supervising study medication infusion if slower infusion rate is better tolerated.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06496750