NCT05457803

Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology

Completed Last updated 4 July 2025

What this trial tests

trial in Chronic Pain in 396 participants. Completed in 15 December 2022.

Timeline

20 July 2022

Primary endpoint
15 December 2022

15 December 2022

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	396
Start date	20 July 2022
Primary completion	15 December 2022
Estimated completion	15 December 2022
Sites	1 location across United States

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Fatigue — all drugs for Fatigue →
• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

18 and older, any sex, with Chronic Pain or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Mitragyna speciosa, also called kratom, is a plant used in Southeast Asia for its psychoactive effects. Its use has increased in the US, and an estimated 10 million adults may take it at least semiregularly. Most scientific research on human use of kratom has consisted of surveys in which people looked back on their experiences with it. Results from those surveys have been useful, but, like many behaviors, kratom use can be more fully understood if it is also studied as it happens. The technical term for this procedure is ecological momentary assessment (EMA). In EMA, people report their moods and activities in real time, a few times per day, usually with a smartphone app.

Objective:

This natural history study will collect data about how people use kratom and how it affects them.

Eligibility:

People aged 18 and older who use kratom 3 or more times per week

Design:

Most participants will be remote only.

They will fill out an online consent form. They will also answer an initial set of questions about their kratom use.

They will download an app on their smartphones for EMA (described above). They will use this app to answer short sets of questions for 15 days in a row about their ongoing behaviors and moods, including kratom use.

They will use a prepaid envelope to mail in a sample of their kratom product.

Some participants, after doing the EMA part of the study, can also come to a clinic. They will have 1 visit for informed consent (1-3 hours) and 1 visit for a monitoring session (8 hours) where we can directly assess the effects of their usual dose of kratom. They will bring their kratom produce with them to take on site.

Before they take the kratom, they will have a physical exam. They will have blood and urine tests. They will answer questions about their sleep, driving, and general feelings. They will complete tasks on a computer to measure their reflexes and response times. Their driving performance will be assessed in a simulator.

Researchers will watch participants consume their kratom. A sample of their product will be taken for analysis.

After taking their kratom, those participants will repeat some questionnaires and tests, including the driving simulation. They will also be interviewed about their use of kratom....

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Responses to a "Typical" Morning Dose of Kratom in People Who Use Kratom Regularly: A Direct-Observation Study.
   Smith KE, Rogers JM, Sharma A, McCurdy CR, et al · · 2024 · cited 17× · PMID 38174871 · DOI 10.1097/adm.0000000000001259
2. Effects of kratom on driving: Results from a cross-sectional survey, ecological momentary assessment, and pilot simulated driving Study.
   Zamarripa CA, Spindle TR, Panlilio LV, Strickland JC, et al · · 2024 · cited 7× · PMID 38497810 · DOI 10.1080/15389588.2024.2327827