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

Conditions

• Herbal Interaction

Eligibility Criteria

Sex

ALL

Age

21 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Kratom — DIETARY_SUPPLEMENT
  Kratom (Moon Kratom Yellow Indonesian, lot 51) is supplied as a dry leaf powder in clear plastic bags, each weighing 5 kg. Two grams of kratom dry leaf powder will be stirred into 240 mL of hot water to make a tea. The tea will be cooled to 50 degrees Celsius before administration. Participants will drink the tea within 15 minutes.
• Oxycodone — DRUG
  Immediate-release oral tablet, 10 mg

Study Details

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

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2026

Primary completion

Nov 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

16 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Arm 1
  Sixteen non-naive\* participants (8 males, 8 females) will be administered a single low dose (2 g) of a well-characterized kratom product by mouth as a tea. Pupil diameter will be measured from 0-12 hours. A washout of at least 10 days will separate Arms 1 and 2. \*Non-naive subjects are defined as intermittent users who consume 2-8 g kratom at least once per month but no more than three times daily within the last six months prior to screening and are willing to abstain for several weeks
• Active Comparator: Arm 2
  The same 16 participants will be administered a single low dose (10 mg) of immediate-release oxycodone by mouth as a tablet. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours. A washout of at least 2 days will separate Arms 2 and 3.
• Experimental: Arm 3
  The same 16 participants will be administered a single low dose (2 g) of kratom as a tea. After 15 minutes, the subjects will be administered a single low dose (10 mg) of oxycodone as a tablet by mouth. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours. A washout of at least 10 days will separate Arms 3 and 4.
• Experimental: Arm 4
  The same 16 participants will self-administer a single low dose (2 g) of kratom as a tea once daily at home. On the fifth day, subjects will return to the research setting, where they will be administered a single low dose (2 g) of kratom, followed 15 minutes later by a single low dose (10 mg) of oxycodone by mouth. Plasma, pupil diameter measurements, and urine will be collected from 0-24 hours.

Primary Outcome Measure

Oxycodone area under the concentration vs. time curve (AUC) ratio (presence to absence of kratom) [ Time Frame: 0-24 hours ]

Central Contacts

• Mary Paine, PhD
  509-358-7759
  [email protected]
• Deena Hadi, BS
  509-368-6692
  [email protected]

Locations (1)

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