RECRUITING

Preliminary Characterization of Commercial Kratom Extract Products

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To understand the acute subjective, physiological, and cognitive effects of commercial kratom extract products among US adults who consume these products regularly, and to understand how these products are metabolized by the human body.

Official Title

Preliminary Characterization of Commercial Kratom Extract Products

Quick Facts

Study Start:2024-11-11

Study Completion:2028-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06640569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kirsten E Smith, MSW, PhD

CONTACT

865-418-8177

ksmit398@jh.edu

Principal Investigator

Kirsten E Smith, MSW, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Johns Hopkins University

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Kirsten E Smith, MSW, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

kratom
kratom extracts
pharmacokinetics
behavioral pharmacology
Mitragyna speciosa

Additional Relevant MeSH Terms

Kratom Pharmacodynamics
Kratom Pharmacokinetics