Preliminary Characterization of Commercial Kratom Extract Products
Recruiting now
Conditions studied: Kratom Pharmacodynamics, Kratom Pharmacokinetics
In brief
To understand the acute subjective, physiological, and cognitive effects of commercial kratom extract products among US adults who consume these products regularly, and to understand how these products are metabolized by the human body.
Key facts
- Study ID
- NCT06640569
- Run by
- Johns Hopkins University
- People needed
- 16
- Starts
- 2024-11-11
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2025-11-17
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 1) >21 years old;
- 2) Experienced kratom extract product consumer of one of the leading US brands listed in the study protocol;
- 3) Reports a specific kratom extract product brand and specific dose amount (or range of typical dose amount) on the online screener;
- 4) English language proficient;
- 5) Willingness to provide requested samples of the kratom extract product currently being taken.
You may not qualify if…
- 1) Reports any acute adverse or unexpected or otherwise sudden health event related to their typical kratom product dose that occurred within 30 days of screening;
- 2) Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product;
- 3) Cannot or will not provide their kratom extract product samples in the form of an unopened package that is clearly labeled with at least the product and vendor name;
- 4)The kratom extract product used by the participant has any semi-synthetic or fully synthetic ingredient listed or is known by the study team to have such an ingredient;
- 5) Currently breastfeeding or pregnant;
- 6) history or current diagnosis of psychotic disorder;
- 7) current untreated bipolar disorder; 8) current untreated major depressive disorder;
- 8) Current physical dependence on alcohol, benzodiazepines, or opioids (self-reported or otherwise evidenced) requiring medical intervention;
- 9) Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen;
- 10) Discordance between self-reported substance use and drug screen results obtained during screening;
- 11)Any physical, psychiatric, environmental, situational, or kratom product-related condition considered by the study team to increase risk or undue burden.
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Johns Hopkins University Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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