RecruitingNCT06089980

Direct Observation Study of Kratom Product Effects Among Regular Consumers

Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.


Sponsor

Johns Hopkins University

Enrollment

22 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Effects from acute kratom exposure for people with kratom, kratom pharmacodynamics, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEffects from acute kratom exposure

Participants who regularly use commercial Kratom products will orally consume a known quantity of kratom under direct observation on first study day; following this, participants will stop kratom use for approximately 2 nights and 2.5 days for the duration of the study.


Locations(1)

Johns Hopkins University

Baltimore, Maryland, United States

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NCT06089980


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