Observing the effects of kratom products on regular users
Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.
This study looks at how regular users of kratom feel and function after taking their usual dose, while also checking what happens when they stop using it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06089980 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 who have been using kratom more than five times a week for at least three months.
Not a fit: Patients who have experienced acute adverse health events related to kratom use or have current dependencies on certain substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of kratom, potentially guiding better usage practices for consumers.
How similar studies have performed: While there is limited research specifically on kratom, studies on similar herbal products have shown varying degrees of success in understanding their effects.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.