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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT06640569
Eligibility Criteria:
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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06640569
Study Brief:
Protocol Section:
NCT06640569