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NCT Number: NCT06496750

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 in 120 adults with moderate to severe methamphetamine use disorder (MUD).

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Methamphetamine Abuse Substance Use Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alameda Health System, San Leandro, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Study participants must:

  • Be 18 to 65 years old
  • Be able to sufficiently understand, speak, and read English
  • Be interested in reducing or stopping methamphetamine use
  • Meet criteria for methamphetamine use disorder
  • Use acceptable methods of contraception during participation in the study

Exclusion criteria

Study participants must not:

  • Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
  • Be currently in jail, prison, or inpatient overnight facility as required by court of law
  • Have upcoming surgery planned or scheduled
  • 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.

Treatment and study plan

Ketamine Hydrochloride

Drug

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.

Other names: Ketelar

Midazolam Hydrochloride

Drug

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.

Other names: Versed

Primary outcomes

  1. Treatment Response

    Time frame: 2 weeks

    Defined as having at least three methamphetamine-negative urine samples out of four samples obtained during Weeks 3 and 4.

Secondary outcomes

  1. Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use

    Time frame: 6 weeks

    Defined by non-serious adverse events (associated with the IV ketamine treatment) reported during the study intervention phase (weeks 1 to 6). Participants will be assessed for adverse events at each study visit.

  2. Adherence to treatment

    Time frame: 6 weeks

    Defined by completion of at least five out of eight IV ketamine or IV midazolam infusions.

  3. Total abstinence

    Time frame: 2 weeks

    Defined as four out of four methamphetamine-negative urine samples obtained during Weeks 3 and 4 (since missing urine drug screens will be counted as positive).

  4. Abstinence from methamphetamine use

    Time frame: 12 weeks

    Defined by the self-reported days of methamphetamine use as reported on the Timeline Followback (TLFB) from Week 1 to Week 4, Week 5 to Week 6, and Week 7 to Week 12.

  5. Differences in methamphetamine-negative urine samples from Weeks 1 to 6 and between ketamine and midazolam arms.

    Time frame: 6 weeks

    Urine samples will be collected twice a week at in-person visits.

  6. Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4.

    Time frame: 4 weeks

    Urine samples will be collected twice a week at in-person visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Casey-Willingham

CONTACT

[email protected]

214-648-4689

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: KMD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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