Understanding the effects of commercial kratom extract products

Preliminary Characterization of Commercial Kratom Extract Products

This study is trying to see how different kratom extract products affect regular users in the U.S. in terms of their feelings, body responses, and thinking after taking a single dose.

Quick facts

• Study type: Observational
• Enrollment: 16 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT06640569 on ClinicalTrials.gov

What this trial studies

This study aims to explore the acute subjective, physiological, and cognitive effects of kratom extract products among regular users in the United States. It focuses on understanding how these products, derived from the Mitragyna speciosa plant, are metabolized in the human body. The pilot study will involve 16 adult participants who will self-administer a single oral dose of their chosen kratom extract product. The research seeks to fill the gap in existing data regarding the pharmacokinetics and pharmacodynamics of these widely used products. No specific hypotheses are being tested, as this is an exploratory proof-of-concept study.

Who should consider this trial

Good fit: Ideal candidates are adults over 21 years old who regularly consume kratom extract products from leading US brands.

Not a fit: Patients who have experienced adverse health events related to kratom use or those who cannot provide product samples will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effects of kratom extract products, informing users and healthcare providers.

How similar studies have performed: While there have been limited studies on kratom, this pilot study represents a novel approach to understanding kratom extract products specifically.

Eligibility criteria

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.

Where this trial is running

Baltimore, Maryland and 1 other locations

• Johns Hopkins University Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Not_yet_recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Kirsten E Smith, MSW, PhD — Johns Hopkins University
• Study coordinator: Kirsten E Smith, MSW, PhD

Conditions Kratom Pharmacodynamics; Kratom Pharmacokinetics; kratom; kratom extracts; pharmacokinetics; behavioral pharmacology; Mitragyna speciosa