Image

Direct Observation Study of Kratom Product Effects Among Regular Consumers

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Eligibility

Inclusion Criteria:

>18 years;

  • Regularly uses kratom;
  • English language proficient;
  • Willingness to provide requested samples of the kratom product they are currently taking.

Exclusion Criteria:

  • Current physical dependence or urine drug screen for substances prohibited for use in this study;
  • Currently pregnant or breastfeeding;
  • Physical, psychiatric, environmental, or situational condition considered by the study team to increase risk or undue burden.

Note: Additional criteria BLINDED and will be provided upon study completion.

Study details

Kratom Withdrawal Symptoms, Kratom Pharmacokinetics, Kratom Pharmacodynamics

NCT06089980

Johns Hopkins University

16 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.