Phase 2
N=22
Single Dose IV Methadone for Post-Op Pain
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT05425420 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Pharmacokinetics (PK) in Adults - Systemic Clearance (CL) — 6.14 liters/hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- methadone hydrochloride 0.1mg/kg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kanecia Obie Zimmerman
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) in Adults - Systemic Clearance (CL) |
6.14 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Volume of Distribution |
318.95 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Elimination Half-life |
39.66 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Plasma AUC0-96 |
1088.9 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - AUC0-inf |
1363.3 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Cmax |
90.92 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Tmax |
0.116 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Cmin |
4.35 | — |
| PRIMARY Pharmacokinetics (PK) in Adults - Elimination Rate Constant |
0.018 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Dark-adapted Pupillometry |
6.95; 7.57 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Thermal Pain Tolerance Threshold |
46.58 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Alertness/Sedation |
91.60 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Energy Level |
89.60 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Confusion |
1.60 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Clumsiness |
2.60 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Anxiety |
1.50 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Nausea |
0.0 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Maximum End-expired CO2 Concentration |
37.40 | — |
| SECONDARY Pharmacodynamics (PD) in Adults - Maximum Sedation Score |
5.0 | — |
Summary
Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.
Eligibility Criteria
Inclusion Criteria
- 18 to 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
- 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) 1.5)
- Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
- Females who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT05425420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.