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Kratom extract effects under the microscope: new study recruits regular users

NCT ID NCT06640569

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study from Johns Hopkins University aims to understand how commercial kratom extract products affect mood, thinking, and physical signs like heart rate and pupil size in adults who use them regularly. Researchers will also study how the body processes these products. The goal is to gather basic information, not to treat any condition.

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

2 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2026

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

US adults who use kratom extract products on a regular basis

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 old; * 2\) Experienced kratom extract product consumer of one of the leading US brands listed in the study protocol; * 3\) Reports a specific kratom extract product brand and specific dose amount (or range of typical dose amount) on the online screener; * 4\) English language proficient; * 5\) Willingness to provide requested samples of the kratom extract product currently being taken. Exclusion Criteria: * 1\) Reports any acute adverse or unexpected or otherwise sudden health event related to their 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 their kratom extract product samples in the form of an unopened package that is clearly labeled with at least the product and vendor name; * 4)The kratom extract product used by the participant has any semi-synthetic or fully synthetic ingredient listed or is known by the study team to have such an ingredient; * 5\) Currently breastfeeding or pregnant; * 6\) history or current diagnosis of psychotic disorder; * 7\) current untreated bipolar disorder; 8) current untreated major depressive disorder; * 8\) Current physical dependence on alcohol, benzodiazepines, or opioids (self-reported or otherwise evidenced) requiring medical intervention; * 9\) Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen; * 10\) Discordance between self-reported substance use and drug screen results obtained during screening; * 11)Any physical, psychiatric, environmental, situational, or kratom product-related condition considered by the study team to increase risk or undue burden.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins University Behavioral Pharmacology Research Unit

    Baltimore, Maryland, 21224, United States

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