Ketamine for Methamphetamine Use Disorder

NCT06496750 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2023-1086
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Methamphetamine Abuse; Substance Use Disorders; Substance Use

Outcome Measures

Primary Outcomes (1)

• Treatment Response

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

  2 weeks

Secondary Outcomes (6)

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

  6 weeks

• Adherence to treatment

  6 weeks

• Total abstinence

  2 weeks

• Abstinence from methamphetamine use

  12 weeks

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

  6 weeks

Study Arms (2)

Ketamine

EXPERIMENTAL

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.

Drug: Ketamine Hydrochloride

Midazolam

ACTIVE COMPARATOR

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.

Drug: Midazolam Hydrochloride

Interventions

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.

Also known as: Ketelar

Ketamine

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.

Also known as: Versed

Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (5)

Alameda Health System

San Leandro, California, 94578, United States

RECRUITING

Interdisciplinary Substance Use and Brain Injury Facility

Albuquerque, New Mexico, 87106, United States

COMPLETED

Addiction Institute of Mount Sinai

New York, New York, 10029, United States

TERMINATED

Prisma Health

Greenville, South Carolina, 29617, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Madhukar Trivedi, MD

  Professor (Tenured)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Casey-Willingham

CONTACT

214-648-4689; Angela.Casey-Willingham@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Psychiatry

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)