Direct Observation Study of Kratom Product Effects Among Regular Consumers (NCT06089980) | Clinical Trial Compass
RecruitingNot Applicable
Direct Observation Study of Kratom Product Effects Among Regular Consumers
United States22 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak subjective opioid withdrawal score
Timeframe: Up to 3 days
2
Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached
Timeframe: up to 3 days
3
Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome)
Timeframe: Up to 3 days
4
Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome)
Timeframe: Up to 3 days
5
Changes in accuracy on psychomotor task (primary cognitive outcome)
Timeframe: Up to 3 days
6
Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome).
. 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.