NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder

What this Trial Is About

Researchers are evaluating whether intravenous (IV) ketamine is more effective than IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD). This 12-week randomized, double-blind, controlled study aims to explore the safety, feasibility, and treatment response of ketamine compared to an active placebo, midazolam, in 120 adults with MUD. The study will help determine the potential for ketamine as a pharmacological treatment for this condition, which currently has no FDA-approved medications and high relapse rates despite psychological interventions. Participants will be randomly assigned to receive either IV ketamine or IV midazolam infusions at doses of 0.50mg/kg and 0.02mg/kg respectively. Each infusion is administered over approximately 45 minutes using an infusion pump, with a total of eight infusions given over six weeks. All participants will also attend weekly medical management sessions with a study clinician during the infusion phase and participate in cognitive behavioral therapy sessions once a week on non-infusion days for the full 12 weeks. Throughout the study, researchers will monitor treatment response primarily at two weeks, as well as secondary outcomes including adherence, abstinence from methamphetamine use up to 12 weeks, and adverse effects related to the treatments. Urine testing for methamphetamine use will be conducted at scheduled intervals. The trial includes a safety and efficacy follow-up period, with participants expected to be involved for a total of 12 weeks from the start of treatment.

Ketamine for Methamphetamine Use Disorder