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NMDA Receptor Antagonist

Ketamine for Substance Abuse (KMD Trial)

Phase 2
Waitlist Available
Led By Manish Jha, MBBS
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Be 18 to 65 years old
2. Be able to sufficiently understand, speak, and read English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

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).

Who is the study for?
Adults with moderate to severe methamphetamine use disorder (MUD) can join this study. The trial is designed for those who are seeking treatment and have not found success with other options.
What is being tested?
The trial is testing if IV ketamine works better than IV midazolam in treating MUD. Participants will be randomly assigned to receive one of the two drugs over a six-week period, as part of a 12-week study.
What are the potential side effects?
Ketamine may cause side effects like disorientation, hallucinations, increased blood pressure, nausea, or vomiting. Midazolam can lead to drowsiness, reduced breathing rate, confusion or memory problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment Response
Secondary study objectives
Abstinence from methamphetamine use
Adherence to treatment
Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4.
+3 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KetamineExperimental Treatment1 Intervention
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.
Group II: MidazolamActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,071 Previous Clinical Trials
1,056,156 Total Patients Enrolled
1 Trials studying Substance Abuse
75 Patients Enrolled for Substance Abuse
Manish Jha, MBBSPrincipal InvestigatorAssociate Professor
~80 spots leftby Feb 2027
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