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Phase 2 N=22 Other

Single Dose IV Methadone for Post-Op Pain

Pain, Postoperative

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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