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Pain, PostoperativePhase 1/2MTH02NCT05425420

Single Dose IV Methadone for Post-Op Pain

A Phase 1/2 study testing methadone hydrochloride 0.1mg/kg in people with Pain, Postoperative, run by Kanecia Obie Zimmerman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
methadone hydrochloride 0.1mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
11 Aug 2023to 20 Jan 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to < 40 years of age at the time of enrollment
  • Provide informed consent

Who cannot join

  • History of cardiac dysfunction
  • History of or current QTc prolongation, defined as > 470 ms in males and > 480 ms in females
  • Known hypersensitivity to methadone hydrochloride or any other ingredient in the methadone hydrochloride injection
  • Known acute bronchial asthma or hypercarbia (known history of known PaCO2 above 45 mm HG)
  • Receipt of a serotonergic drug or buproprion within 7 days prior to study enrollment
  • Receipt of benzodiazepines, muscle relaxants, or other opioids within 7 days prior to study enrollment
Show all 16Show fewer
  • Receipt of a moderate or strong CYP2B6 inhibitor or inducer - either prescription or non-prescription medications, herbals,34 or foods known to be metabolized by or affecting CYP2B6 - within 30 days prior to study enrollment
  • CYP2B6 inhibitors include clopidogrel, prasugrel, thioTEPA, ticlopidine, voriconazole, macrolide antibiotics, azole-antifungal agents, fluconazole, Alstonia boonei, Mangifera indica, and Picralima nitida
  • CYP2B6 inducers include artemisinin antimalarials, barbiturates, carbamazepine, cyclophosphamide, efavirenz, lopinavir, methimazole, nelfinavir, phenobarbital, phenytoin, primidone, rifampicin/rifampin, ritonavir, abacavir, amprenavir, nevirapine, telaprevir
  • Receipt of zidovudine, desipramine, or other drugs that may increase serum concentration when combined with methadone within 30 days prior to study enrollment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Significant respiratory depression (respiratory rate less than 8 breaths/min or oxygen saturation (SpO2) <95%)
  • BMI ≥ 33 and BMI ≤ 17
  • Known history of moderate-to-severe liver (Child Class B or C) or kidney disease (serum creatinine > 1.5)
  • Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
  • Females who are pregnant or nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Early Phase Unit (DEPRU

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02)

Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.

Read the detailed description

The Adult Methadone study will be conducted at a single site, Duke Early Phase Research Unity (DEPRU), to enroll 24 participants. Participants will be treated/monitored overnight with Methadone hydrochloride IV (FDA approved and commercially available), with daily follow-up visits for 1 week total. The study aims to provide information on the disposition and clinical effects of intravenous methadone to update the drug label.

Being tested
methadone hydrochloride 0.1mg/kg
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methadone hydrochloride 0.1mg/kgDrug

    Single dose of methadone hydrochloride administered via intravenous (IV)

Study groups in NCT05425420
Study groupRoleWhat they receive
Single arm, Open label Methadone IVExperimentalAll participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.
Receives: Drug: methadone hydrochloride 0.1mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK) in Adults - Systemic Clearance (CL)

    Measured: 96 hours after dosing

  2. Pharmacokinetics (PK) in Adults - Volume of Distribution

    Measured: 96 hours after dosing

  3. Pharmacokinetics (PK) in Adults - Elimination Half-life

    Measured: 96 hours after dosing

  4. Pharmacokinetics (PK) in Adults - Plasma AUC0-96

    Plasma AUC0-96 is the area under the plasma concentration versus time curve from time zero to 96 hours post-dose.

    Measured: 96 hours after dosing

  5. Pharmacokinetics (PK) in Adults - AUC0-inf

    AUC0-inf is the area under the curve from time 0 extrapolated to infinite time.

    Measured: 96 hours after dosing

  6. Pharmacokinetics (PK) in Adults - Cmax

    Cmax: A pharmacokinetic measure used to determine drug dosing. Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.

    Measured: 96 hours after dosing

  7. Pharmacokinetics (PK) in Adults - Tmax

    Tmax is the time corresponding to maximum concentration post-dose.

    Measured: 96 hours after dosing

  8. Pharmacokinetics (PK) in Adults - Cmin

    Cmin is the observed minimum concentration post-dose.

    Measured: 96 hours after dosing

  9. Pharmacokinetics (PK) in Adults - Elimination Rate Constant

    Elimination rate constant (ke)-s a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system.

    Measured: 96 hours after dosing

Secondary outcomes (10)

  1. Pharmacodynamics (PD) in Adults - Dark-adapted Pupillometry

    Dark-adapted pupillometry measured pupil diameter using a goggle-based, camera-like device. A goggle-based system effectively allowed the participant to be in the dark while room lights were on for research staff.

    Measured: 96 hours after dosing

  2. Pharmacodynamics (PD) in Adults - Thermal Pain Tolerance Threshold

    The thermal pain tolerance threshold is the highest tolerated temperature change. Thermal pain tolerance was measured by a 3 cm2 computer-controlled Peltier-type thermal stimulator. The stimulator delivered painful heat stimuli to the volar side of the forearm. The thermode system's baseline temperature was set at 32°C. The computer-controlled thermode system was programmed to gradually increase the stimulus (0.8°C/sec) until participants pressed a stop button, which indicates maximum tolerable temperature was reached and initiated immediate thermode cooling. The maximum tolerable temperature was recorded.

    Measured: 96 hours after dosing

  3. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Alertness/Sedation

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for alertness/sedation ranges from 0 (almost asleep) to 100 (wide awake).

    Measured: 96 hours after dosing

  4. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Energy Level

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for energy level ranges from 0 (no energy) to 100 (full of energy).

    Measured: 96 hours after dosing

  5. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Confusion

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for confusion ranges from 0 (clear headed) to 100 (confused).

    Measured: 96 hours after dosing

  6. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Clumsiness

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for clumsiness ranges from 0 (well-coordinated) to 100 (extremely clumsy).

    Measured: 96 hours after dosing

  7. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Anxiety

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for anxiety ranges from 0 (calm/relaxed) to 100 (extremely nervous).

    Measured: 96 hours after dosing

  8. Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Nausea

    Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for nausea ranges from 0 (no nausea) to 100 (worst nausea).

    Measured: 96 hours after dosing

  9. Pharmacodynamics (PD) in Adults - Maximum End-expired CO2 Concentration

    Measured in mmHg

    Measured: 96 hours after dosing

  10. Pharmacodynamics (PD) in Adults - Maximum Sedation Score

    Maximum sedation score obtained via the Modified Observer's Assessment of Alertness/Sedation (MOAA/S). The MOAA/S has a scale of 0 to 5, where 0 = "Does not respond to painful trapezius squeeze" and 5 = "Responds readily to name spoken in normal tone".

    Measured: 96 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start11 Aug 2023
  3. Primary completion20 Jan 2024
  4. Study completion20 Jan 2024

Resources

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 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects will be studied on one occasion in the Early Phase Research Unit at Duke University Medical Center for administration of drug, collection of blood samples, and measurements of drug effect. Study drug is intravenous methadone hydrochloride Plasma samples collections are obtained up to 96 hr after dosing. Dark-adapted pupil diameter is measured by infrared camera. Responses to thermal skin stimulation are recorded. Respiratory rate and end-tidal carbon dioxide concentrations are measured. Subject self-assessment of methadone effect is performed using verbal analog scales. Blood samples obtained during the study will be analyzed for plasma concentrations of methadone.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425420
Sponsor's protocol ID
Pro00113821
Other IDs
Pro00106216
Acronym
MTH02
Status last verified
Jan 2025
First submitted
15 Apr 2022
Last updated
10 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing methadone hydrochloride 0.1mg/kg in people with Pain, Postoperative, run by Kanecia Obie Zimmerman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) in Adults - Systemic Clearance (CL) (time frame: 96 hours after dosing). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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