NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
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).
Description
Effective management for methamphetamine use disorder (MUD) remains elusive, despite widespread misuse of this stimulant. Psychological interventions have demonstrated modest benefits, and relapse rates are high. There are currently no Food and Drug Administration (FDA)-approved pharmacotherapies for MUD. This study explores the efficacy, safety, and feasibility for intravenous (IV) ketamine as a treatment for MUD and will help to determine the effect size for a larger, multi-site trial of intravenous (IV) ketamine in MUD. Participants will receive either IV ketamine (0.50mg/kg) or IV midazol…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 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 o…
Interventions
- DrugKetamine 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.
- DrugMidazolam 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 SystemSan Leandro, California
- Interdisciplinary Substance Use and Brain Injury FacilityAlbuquerque, New Mexico
- Addiction Institute of Mount SinaiNew York, New York
- Prisma HealthGreenville, South Carolina
- UT Southwestern Medical CenterDallas, Texas