RECRUITING

Direct Observation Study of Kratom Product Effects Among Regular Consumers

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

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.

Official Title

Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.

Quick Facts

Study Start:2024-04-01
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06089980

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Regularly uses kratom;
  2. * English language proficient;
  3. * Willingness to provide requested samples of the kratom product they are currently taking.
  1. * Current physical dependence or urine drug screen for substances prohibited for use in this study;
  2. * Currently pregnant or breastfeeding;
  3. * Physical, psychiatric, environmental, or situational condition considered by the study team to increase risk or undue burden.

Contacts and Locations

Study Contact

Kirsten E Smith, Ph.D.
CONTACT
410-550-0490
ksmit398@jh.edu
Jeff D Feldman, B.A.
CONTACT
410-550-0490
jfeldm26@jh.edu

Principal Investigator

Kirsten E Smith, Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Kirsten E Smith, Ph.D., 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 Date2024-04-01
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • kratom

Additional Relevant MeSH Terms

  • Kratom Pharmacokinetics
  • Kratom Pharmacodynamics
  • Kratom