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Kratom under the microscope: new study tracks immediate effects and withdrawal in regular users

NCT ID NCT06089980

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study from Johns Hopkins University is watching 22 adults who regularly use kratom. On the first day, participants take their usual dose under supervision, then stop for about 2.5 days. Researchers measure physical and mental effects, including withdrawal symptoms, to better understand how commercial kratom products work and what happens when use stops.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
kratom
What this could lead to
If successful, this study could provide clearer data on kratom's acute effects and withdrawal symptoms, helping to inform future research on its safety and potential risks.
What could go wrong
This is a small, early observational study with only 22 regular users, so results may not apply to occasional users or the general public. It does not test any treatment or long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy adults aged 21 or older who use kratom.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: 1. \>21 years 2. reporting kratom use \>5 times per week for \>3 months prior to study screening 3. English language proficiency 4. Willingness to provide requested samples of the kratom product being currently taken EXCLUSION CRITERIA: 1. Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening 2. Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product. 3. 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. 4. Self-reports using kratom products by any other route than orally swallowing. 5. Current physical dependence on alcohol, benzodiazepines, or opioids 6. Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen. 7. Discordance between self-reported substance use and drug screen results obtained during screening. 8. Lifetime or current psychotic disorder 9. Current untreated major depressive or bipolar disorder 10. Pregnancy or nursing 11. Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

KRATOM Kratom pharmacodynamics Kratom pharmacokinetics

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21224, United States

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