NCT06640569 Preliminary Characterization of Commercial Kratom Extract Products
| NCT ID | NCT06640569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Kratom Pharmacodynamics |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2027-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2024-11-11 with a primary completion date of 2027-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Kirsten E Smith, MSW, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06640569 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Kratom Pharmacodynamics. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06640569 currently recruiting?
Yes, NCT06640569 is actively recruiting participants. Contact the research team at ksmit398@jh.edu for enrollment information.
Where is the NCT06640569 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States.
Who is sponsoring the NCT06640569 clinical trial?
NCT06640569 is sponsored by Johns Hopkins University. The principal investigator is Kirsten E Smith, MSW, PhD at Johns Hopkins University. The trial plans to enroll 16 participants.