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Ketamine for Methamphetamine Use Disorder
Sponsor: University of Texas Southwestern Medical Center
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).
Official title: NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-09-11
Completion Date
2026-10-15
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
Ketamine Hydrochloride
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.
Midazolam Hydrochloride
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)
Alameda Health System
San Leandro, California, United States
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