Substance Use DisordersPhase 2KMDNCT06496750
Ketamine for Methamphetamine Use Disorder
A Phase 2 study testing Ketamine Hydrochloride and Midazolam Hydrochloride in people with Substance Use Disorders and Substance Use, run by University of Texas Southwestern Medical Center at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders, Substance Use, Methamphetamine Abuse
- What is being tested?
- Ketamine Hydrochloride and Midazolam Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Sep 2024to Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Interdisciplinary Substance Use and Brain Injury Facility
Albuquerque, New Mexico, 87106
UT Southwestern Medical Center
Dallas, Texas, 75247
Prisma Health
Greenville, South Carolina, 29617
Addiction Institute of Mount Sinai
New York, New York, 10029
Alameda Health System
San Leandro, California, 94578
About this study
Official title: NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
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).
Read the detailed 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.
- Being tested
- Ketamine Hydrochloride, Midazolam Hydrochloride
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called Ketelar
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.
Midazolam HydrochlorideDrug
Also called Versed
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Midazolam Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response
Defined as having at least three methamphetamine-negative urine samples out of four samples obtained during Weeks 3 and 4.
Measured: 2 weeks
Secondary outcomes (6)
Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use
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.
Measured: 6 weeks
Adherence to treatment
Defined by completion of at least five out of eight IV ketamine or IV midazolam infusions.
Measured: 6 weeks
Total abstinence
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).
Measured: 2 weeks
Abstinence from methamphetamine use
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.
Measured: 12 weeks
Differences in methamphetamine-negative urine samples from Weeks 1 to 6 and between ketamine and midazolam arms.
Urine samples will be collected twice a week at in-person visits.
Measured: 6 weeks
Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4.
Urine samples will be collected twice a week at in-person visits.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start11 Sep 2024
- Primary completion6 Sep 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, MD, Principal investigator, Professor (Tenured)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496750
- Sponsor's protocol ID
- STU-2023-1086
- Acronym
- KMD
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No