Status:
RECRUITING
Direct Observation Study of Kratom Product Effects Among Regular Consumers
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of Florida
National Institute on Drug Abuse (NIDA)
Conditions:
Kratom Pharmacokinetics
Kratom Pharmacodynamics
Eligibility:
All Genders
21+ years
Brief Summary
The goal of this observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly. The main questions it aims to answer are: 1...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- \>21 years
- reporting kratom use \>5 times per week for \>3 months prior to study screening
- English language proficiency
- Willingness to provide requested samples of the kratom product being currently taken
- EXCLUSION CRITERIA:
- Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening
- Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product.
- 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.
- Self-reports using kratom products by any other route than orally swallowing.
- Current physical dependence on alcohol, benzodiazepines, or opioids
- Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen.
- Discordance between self-reported substance use and drug screen results obtained during screening.
- Lifetime or current psychotic disorder
- Current untreated major depressive or bipolar disorder
- Pregnancy or nursing
- Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).
Exclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06089980
Start Date
April 1 2024
End Date
February 1 2028
Last Update
January 22 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21224