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IV Methadone for Postoperative Pain (MTH02 Trial)

Q: Are individuals aged 70 and above eligible to participate in this research?

The upper and lower age limits for participants in this study are 18 and 40 respectively.

Q: Do I fulfill the prerequisites for participating in this experiment?

This medical study seeks 20 patients aged 18 to 40 with postoperative <a href="https://www.withpower.com/clinical-trials/pain">pain</a>. Interested individuals must meet the following requirements: between 18 and &#x3C;40 at the time of enrollment, give informed consent.

Q: Is enrollment currently available for this research endeavor?

Evidence found on clinicaltrials.gov points to the current recruitment of participants for this medical trial, which was first announced on August 11th 2023 and recently revised September 22nd 2023.

Q: How many individuals have opted to be a part of this clinical experiment?

Affirmative. According to clinicaltrials.gov, this medical research is actively recruiting patients since its original posting on August 11th 2023 and has been updated as recently as September 22nd 2023. The study requires the enrollment of twenty individuals from a single trial site.

Phase 1 & 2

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hours after dosing

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.

0 / 1Eligibility criteria met

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 70 and above eligible to participate in this research?

"The upper and lower age limits for participants in this study are 18 and 40 respectively."

Answered by AI

Do I fulfill the prerequisites for participating in this experiment?

"This medical study seeks 20 patients aged 18 to 40 with postoperative pain. Interested individuals must meet the following requirements: between 18 and <40 at the time of enrollment, give informed consent."

Answered by AI

Is enrollment currently available for this research endeavor?

"Evidence found on clinicaltrials.gov points to the current recruitment of participants for this medical trial, which was first announced on August 11th 2023 and recently revised September 22nd 2023."

Answered by AI

How many individuals have opted to be a part of this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical research is actively recruiting patients since its original posting on August 11th 2023 and has been updated as recently as September 22nd 2023. The study requires the enrollment of twenty individuals from a single trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Dose IV Methadone for Post-Op Pain

Kanecia Obie Zimmerman 2023. "Single Dose IV Methadone for Post-Op Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425420.