Using ketamine to treat methamphetamine use disorder
NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
This study is testing if ketamine can help adults with methamphetamine use disorder feel better compared to another medication called midazolam over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 5 sites (San Leandro, California and 4 other locations) |
| Trial ID | NCT06496750 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravenous (IV) ketamine compared to IV midazolam in treating adults with moderate to severe methamphetamine use disorder (MUD). It is a 12-week randomized, double-blind, controlled trial involving 120 participants who will receive eight infusions of either ketamine or midazolam over six weeks. In addition to the infusions, participants will engage in weekly medical management sessions and cognitive behavioral therapy (CBT) to support their treatment. The goal is to assess the efficacy, safety, and feasibility of ketamine as a potential pharmacotherapy for MUD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the criteria for methamphetamine use disorder and are motivated to reduce or stop their methamphetamine use.
Not a fit: Patients currently incarcerated, pregnant, or those who have participated in addiction treatment studies within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new pharmacological option for individuals struggling with methamphetamine use disorder.
How similar studies have performed: While the use of IV ketamine for other psychiatric disorders has shown promise, this specific application for methamphetamine use disorder is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 by the study investigators at the screening visit.
Where this trial is running
San Leandro, California and 4 other locations
- Alameda Health System — San Leandro, California, United States (Recruiting)
- Interdisciplinary Substance Use and Brain Injury Facility — Albuquerque, New Mexico, United States (Completed)
- Addiction Institute of Mount Sinai — New York, New York, United States (Terminated)
- Prisma Health — Greenville, South Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Madhukar Trivedi, MD — Professor (Tenured)
- Study coordinator: Angela Casey-Willingham
- Email: Angela.Casey-Willingham@UTSouthwestern.edu
- Phone: 214-648-4689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.