Ketamine for Methamphetamine Use Disorder (KMD)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2

Conditions: Substance Use; Substance Use Disorders; Methamphetamine Abuse

Treatments: Drug: Ketamine Hydrochloride; Drug: Midazolam Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06496750

STU-2023-1086

Details and patient eligibility

About

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).

Full 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 midazolam (0.02mg/kg) over 45 minutes per infusion for a total of eight (8) infusions over six (6) weeks. Medical management sessions with a study clinician will be provided to all participants once weekly (from Weeks 1 through 6).

The use of IV ketamine in this trial is consistent in dose (0.5 mg/kg) and duration of infusion (45-minute-long) to other studies of ketamine for psychiatric disorders (such as major depressive disorder and post-traumatic stress disorder, both of which are often comorbid in individuals with MUD) and substance use disorder. However, IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet.

Additionally, participants will be asked to participate in cognitive behavioral therapy (CBT) sessions once weekly (from Weeks 1 through 12) on a non-infusion day.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Ketamine

Experimental group

Description:

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 at a constant rate over 40 minutes. IV ketamine will be administered 8 times over 6 weeks.

Treatment:

Drug: Ketamine Hydrochloride

Midazolam

Active Comparator group

Description:

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 at a constant rate over 40 minutes. IV midazolam will be administered 8 times over 6 weeks.

Treatment:

Drug: Midazolam Hydrochloride