Preliminary Characterization of Commercial Kratom Extract Products
Stopped: Original PI left study team, ending project funding.
United States2 participantsStarted 2024-11-11
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug Effects Questionnaire
Timeframe: Administered at 7 timepoints on Study Days 1-2
2
Cognitive Effects as assessed by the Digit Symbol Substitution Task
Timeframe: Administered at 7 time points on Study Days 1-2
3
Pupil size
Timeframe: Measured at 7 timepoints on Study Days 1-2
4
Resting Heart Rate
Timeframe: Measured at 7 timepoints on Study Days 1-2