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Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 1, 2025 to Nov 1, 2026
    • Study completion date: May 1, 2025 to Dec 1, 2026
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Start date changed from estimate of Oct 1, 2023 to Jun 1, 2023v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to investigate whether the botanical product kratom affects how the body processes the opioid drug oxycodone. The main research questions to be answered are two-fold: 1. How does kratom affect the manner in which oxycodone is metabolized (broken down and removed) by the body? 2. Does kratom change the effects oxycodone exerts on the body? Healthy adult participants will complete four study arms, during which they will be given the following: * Kratom (as a tea) * A single dose of oxycodone (as a tablet) * Kratom tea and a single dose of oxycodone * Kratom tea for four days, then kratom tea and a single dose of oxycodone
Trial Details
NCT Number NCT05846451
Lead Sponsor Washington State University
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions
(from sponsor)		 Herbal Interaction
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov