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IV Methadone for Postoperative Pain (MTH02 Trial)

Phase 1 & 2
Waitlist Available
Led By Kanecia Zimmerman, MD, MPH
Research Sponsored by Kanecia Obie Zimmerman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to < 40 years of age at the time of enrollment
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours after dosing
Awards & highlights

MTH02 Trial Summary

This trial studied how methadone affects adults in the body and how their bodies react to it.

Who is the study for?
This trial is for adults aged 18 to under 40 who can consent to participate. It's not suitable for those with heart issues, prolonged QTc interval, methadone allergies, severe asthma or breathing problems, recent use of certain drugs like serotonergic drugs or opioids, pregnant or nursing women, people with gastrointestinal blockage, high BMI (≥33), liver/kidney disease, or a history of substance addiction.Check my eligibility
What is being tested?
The study tests a single intravenous dose of methadone hydrochloride (0.1mg/kg) in managing postoperative pain. It's an open-label and single-session study focusing on how the body processes the drug and its effects on pain relief in adults after surgery.See study design
What are the potential side effects?
Potential side effects may include cardiac issues due to QTc prolongation risk; allergic reactions; respiratory depression; interactions with other medications affecting CYP2B6 enzyme system; and typical opioid-related side effects such as nausea, drowsiness or mood changes.

MTH02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 39 years old.

MTH02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours after dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK) in Adults
Secondary outcome measures
Characterize the tolerability
Pharmacodynamics (PD) in Adults
Serious adverse events (SAEs)
+1 more

MTH02 Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm, Open label Methadone IVExperimental Treatment1 Intervention
All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
methadone hydrochloride 0.1mg/kg
2023
Completed Phase 2
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kanecia Obie ZimmermanLead Sponsor
8 Previous Clinical Trials
3,155 Total Patients Enrolled
Kanecia Zimmerman, MD, MPHPrincipal InvestigatorDUMC, DCRI
5 Previous Clinical Trials
4,970 Total Patients Enrolled
Evan Kharasch, MD, PhDPrincipal InvestigatorDUMC, Anesthesia
5 Previous Clinical Trials
262 Total Patients Enrolled
~12 spots leftby Jun 2025
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