Status:
COMPLETED
Single Dose IV Methadone for Post-Op Pain
Lead Sponsor:
Kanecia Obie Zimmerman
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.
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 hydroc...
Eligibility Criteria
Inclusion
- 18 to \< 40 years of age at the time of enrollment
- Provide informed consent
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05425420
Start Date
August 11 2023
End Date
January 20 2024
Last Update
February 10 2025
Active Locations (1)
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1
Duke Early Phase Unit (DEPRU
Durham, North Carolina, United States, 27710