Actively Recruiting
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
Led by Washington State University · Updated on 2024-12-20
16
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
W
Washington State University
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 21 to 45 years
- Body weight between 130 and 250 pounds (60-115 kg) and body mass index between 19 and 30
- Not currently taking medications or supplements known to affect oxycodone or kratom metabolism
- Willing to avoid supplements, botanical products, and fruit juices for several weeks
- Willing to abstain from cannabis, hemp, THC, and CBD products for several weeks
- Willing to avoid caffeinated beverages the evening before and morning of inpatient visits
- Willing to avoid alcohol for one day before inpatient visits
- Willing to use non-hormonal contraception methods
- Have previously consumed kratom and tolerated it well
- Willing to abstain from kratom for several weeks
- Have previously used any opioid and tolerated it well without unpleasant effects or addiction
- Able to give written informed consent and comply with study requirements
- Reside within 40 miles of Spokane and have time to participate
You will not qualify if you...
- Under 21 or over 45 years of age
- Weigh less than 130 pounds or more than 250 pounds
- Body mass index less than 19 or greater than 30
- Current major or chronic illnesses such as kidney, liver, diabetes, heart, lung diseases, cancer, or HIV/AIDS
- No prior exposure to kratom
- No prior exposure to opioids
- History of anemia or significant blood disorders
- History of substance abuse, dependence, addiction, or major psychiatric illness
- Need for chronic opioid pain medications
- Use of opioid pain medications within 3 weeks before study start
- Expected need for opioid pain medications soon (e.g., planned surgery)
- Pregnant or nursing
- Allergy or intolerance to kratom, opioids, or oxycodone
- Taking medications or supplements that affect kratom or oxycodone metabolism
- Any condition that may compromise participant safety or data quality
- History of sleep apnea
- Previous recreational use of drugs like amphetamines, benzodiazepines, cocaine, MDMA, PCP, or opioids
- Use of cannabis, hemp, THC, or CBD products within the last month
- Laboratory values outside normal range posing health risks
- Inability to speak, read, and understand English
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, United States, 99202
Actively Recruiting
Research Team
M
Mary Paine, PhD
CONTACT
D
Deena Hadi, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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