Observing the effects of kratom products on regular users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the effects of commercial kratom products on healthy adults who consume them regularly. Participants will self-administer a single oral dose of their usual kratom product, and the study will assess the acute physiological, subjective, and cognitive effects of this dose. Additionally, the study will explore the effects of kratom product discontinuation and analyze the pharmacokinetics of kratom in regular users through blood draws and urine collection. The goal is to gather comprehensive data on how kratom affects users in real-time.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

1. \>21 years
2. reporting kratom use \>5 times per week for \>3 months prior to study screening
3. English language proficiency
4. Willingness to provide requested samples of the kratom product being currently taken

EXCLUSION CRITERIA:

1. Reports any acute adverse, unexpected, or otherwise sudden health event related to the 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 kratom product samples in the form of an unopened package of kratom that is clearly labeled with at least the product and vendor name.
4. Self-reports using kratom products by any other route than orally swallowing.
5. Current physical dependence on alcohol, benzodiazepines, or opioids
6. Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen.
7. Discordance between self-reported substance use and drug screen results obtained during screening.
8. Lifetime or current psychotic disorder
9. Current untreated major depressive or bipolar disorder
10. Pregnancy or nursing
11. Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Kirsten E Smith, Ph.D. — Johns Hopkins University
• Study coordinator: Kirsten E Smith, Ph.D.
• Email: ksmit398@jh.edu
• Phone: 865-418-8177

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.