Actively Recruiting
Direct Observation Study of Kratom Product Effects Among Regular Consumers
Led by Johns Hopkins University · Updated on 2026-01-23
22
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
University of Florida
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. What are the acute physiological, subjective, and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose? 2. What are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly? 3. What are the pharmacokinetics of kratom products consumed by adults who use regularly? On the first study day: Under direct observation, participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical dose/serving. Following this, serial blood draws and urine collection will occur along with administration of validated questionnaires, tests, and continual monitoring. After this first study day, participants will no longer be permitted to use any of the participants kratom product during the study. On study nights/days 2-3: participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome.
CONDITIONS
Official Title
Direct Observation Study of Kratom Product Effects Among Regular Consumers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 21 years or older
- Use kratom more than 5 times per week for over 3 months before screening
- Be able to speak English
- Willing to provide samples of the kratom product currently used
You will not qualify if you...
- Experienced any sudden or unexpected health problems after a typical kratom dose within 30 days before screening
- Ever needed medical care for a sudden health problem caused by kratom
- Unable or unwilling to provide unopened, clearly labeled kratom product packages
- Use kratom by any method other than swallowing orally
- Currently physically dependent on alcohol, benzodiazepines, or opioids
- Used fentanyl in the past month or tested positive for fentanyl
- Discrepancy between reported substance use and drug test results
- Have a current or past psychotic disorder
- Have untreated major depressive or bipolar disorder
- Are pregnant or nursing
- Have physical, mental, or environmental issues that increase risk or burden, such as untreated high blood pressure or high body mass index
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
K
Kirsten E Smith, Ph.D.
CONTACT
N
Naftali Zeilinger, B.A.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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