Direct Observation Study of Kratom Product Effects Among Regular Consumers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Effects from acute kratom exposure.
- Who it may be relevant to
- Registry conditions: Kratom Pharmacokinetics, Kratom Pharmacodynamics, Kratom. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.
Overview
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.
Interventions
- Behavioral Effects 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.
Primary outcome measures
- Peak subjective opioid withdrawal score [Time frame: Up to 3 days]
- Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached [Time frame: up to 3 days]
- Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome) [Time frame: Up to 3 days]
- Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome) [Time frame: Up to 3 days]
- Changes in accuracy on psychomotor task (primary cognitive outcome) [Time frame: Up to 3 days]
- Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome). [Time frame: Up to 3 days]
Eligibility criteria
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Johns Hopkins University — Baltimore
Identifiers
NCT: NCT06089980 · IRB00408134 · R00DA055571