Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT05846451
Eligibility Criteria:
Inclusion Criteria:
* Males and females, aged from 21-45 years and healthy
* Body weight between 130 and 250 pounds (60-115 kg) and body mass index between 19 and 30
* Not taking any medications (prescription and non-prescription) or dietary supplements/botanical products known to alter the pharmacokinetics of either oxycodone or kratom
* Willing to abstain from consuming dietary supplements/botanical products and fruit juices for several weeks
* Willing to abstain from cannabis/marijuana, hemp, and THC- and/or CBD-containing products for several weeks
* Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient visit
* Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient visit
* Willing to use an additional method of contraception that does not include oral contraceptive pills, patches, or other hormonal methods (such as abstinence, copper IUD, or condoms)
* Have consumed kratom previously and tolerated it well without any unpleasant effects
* Willing to abstain from kratom for several weeks
* Have consumed any opioid previously and tolerated it well without any unpleasant effects or addiction
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study
* Geographically located within a 40-mile radius of Spokane and have the time to participate
Exclusion Criteria:
* Males and females under the age of 21 or over the age of 45
* People who weigh less than 130 pounds or more than 250 pounds
* People with a body mass index less than 19 or greater than 30
* Any current major illness or chronic illness including but not limited to kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
* No previous exposure to kratom
* No previous exposure to an opioid
* History of anemia or any other significant hematologic disorder
* History of substance abuse, dependence, or addiction or major psychiatric illness
* A need for chronic opioid analgesics
* Use of opioid analgesics 3 weeks prior to initiation of the study
* An imminent likely need for opioid analgesics (e.g., planned dental or surgical procedure)
* Pregnant or nursing
* History of allergy or intolerance to kratom, other opioids, or oxycodone
* Taking concomitant medications, both prescription and non-prescription (including dietary supplements/botanical products), known to alter the pharmacokinetics of kratom or oxycodone
* Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
* History of sleep apnea
* Any prior use of amphetamines, benzodiazepines, cocaine, MDMA, opioids, PCP, or other drugs for recreational purposes
* Use of cannabis/marijuana, hemp, THC-containing products, CBD-containing products, or CBD within the last month
* Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk
* Inability to speak, read, and understand English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT05846451
Study Brief:
Protocol Section:
NCT05846451