Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers

About the Study

Currently Recruiting: Participants

Study Drug/Intervention: Methadone/hydrochloride 0.1mg/kg

Study Timeline: This study is expected to conclude in August 2025.

Visit the Study Website ID: NCT05425420


Study Objective

This study will evaluate how healthy adults process methadone administered through IV. It is needed to determine the optimal dose of methadone and to understand variations in drug disposition. Methadone is already approved by the U.S. Food and Drug Administration for treatment of pain management and Opioid Use Disorder (OUD) in adults. Results from MTH02 will help update information on dosing methadone for adults, and they will lay the foundation for studies to label methadone for treating acute pain and OUD in children.

Inclusion & Exclusion Criteria

Inclusion Criteria:

  1. 18 to < 40 years of age at the time of enrollment
  2. Provide informed consent

Exclusion Criteria:

  1. History of cardiac dysfunction
  2. History of or current QTc prolongation, defined as > 470 ms in males and > 480 ms in females
  3. Known hypersensitivity to methadone hydrochloride or any other ingredient in the methadone hydrochloride injection
  4. Known acute bronchial asthma or hypercarbia
  5. Receipt of a serotonergic drug or buproprion within 7 days prior to study enrollment
  6. Receipt of benzodiazepines, muscle relaxants, or other opioids within 7 days prior to study enrollment
  7. 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 – in last 30 days
    1. CYP2B6 inhibitors include clopidogrel, prasugrel, thioTEPA, ticlopidine, voriconazole, macrolide antibiotics, azole-antifungal agents, fluconazole, Alstonia boonei, Mangifera indica, and Picralima nitida
    2. CYP2B6 inducers include artemisinin antimalarials, barbiturates, carbamazepine, cyclophosphamide, efavirenz, lopinavir, methimazole, nelfinavir, phenobarbital, phenytoin, primidone, rifampicin/rifampin, ritonavir, abacavir, amprenavir, nevirapine, telaprevir
  8. Receipt of zidovudine, desipramine, or other drugs that may increase serum concentration when combined with methadone
  9. Known or suspected gastrointestinal obstruction, including paralytic ileus
  10. Significant respiratory depression
  11. BMI ≥ 33
  12. Known history of moderate-to-severe liver (Child Class B or C) or kidney disease (serum creatinine > 1.5)
  13. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
  14. Females who are pregnant or nursing

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