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RECRUITINGPhase 2INTERVENTIONAL

Ketamine for Methamphetamine Use Disorder

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

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.

DRUG

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