Ketamine for Methamphetamine Use Disorder
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
| Condition(s) | Substance Use Disorders, Substance Use, Methamphetamine Abuse |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 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 b |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | San Leandro, California, United States; Albuquerque, New Mexico, United States; New York, New York, United States; Greenville, South Carolina, United States; Dallas, Texas, United States |
| Start date | 2024-09-11 |
| NCT ID | NCT06496750 |
| Official listing | https://clinicaltrials.gov/study/NCT06496750 |