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NCT06089980 · ClinicalTrials.gov registry record
Direct Observation Study of Kratom Product Effects Among Regular Consumers
A clinical trial of Kratom Pharmacodynamics and Kratom Pharmacokinetics, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- 22
- Enrollment target
- 1
- Study location
NCT06089980: Recruiting study of Kratom Pharmacodynamics and Kratom Pharmacokinetics, sponsored by Johns Hopkins University.
NCT06089980 is a study of Kratom Pharmacodynamics and Kratom Pharmacokinetics that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 22 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06089980, a study of Kratom Pharmacodynamics and Kratom Pharmacokinetics, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Peak score on the Subjective Opioid Withdrawal Scale (SOWS); that occurs between Study Days 1-3. Score range 0-64. 5-point scale of intensity: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. Higher score indicates higher intensity. SOWS will be administered at 8 time points on Study Days 1-2 and 7 time points on Study Day 3.
Conditions Studied
Interventions
- BEHAVIORAL Effects from acute kratom exposure
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2028-02 |
What NCT06089980 shows while recruiting
NCT06089980 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 3 conditions, with Kratom Pharmacodynamics appearing as the primary indexed condition, and to 1 intervention - of which Effects from acute kratom exposure is the first listed.
NCT06089980 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06089980 about?
NCT06089980 is a clinical study titled "Direct Observation Study of Kratom Product Effects Among Regular Consumers". 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 participan...
What is the current status of trial NCT06089980?
This trial is currently recruiting. The enrollment target is 22 participants. The study started on 2024-04-01. Estimated completion is 2028-02.
What conditions does trial NCT06089980 study?
This clinical trial studies the following conditions: Kratom Pharmacodynamics, Kratom Pharmacokinetics, Kratom.
What interventions are being tested in trial NCT06089980?
The interventions under investigation include: Effects from acute kratom exposure (BEHAVIORAL).
Who is sponsoring clinical trial NCT06089980?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06089980 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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