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NCT05457803 · ClinicalTrials.gov registry record
Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology
A clinical trial, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- 396
- Enrollment target
NCT05457803: Completed study, sponsored by National Institute on Drug Abuse (NIDA).
NCT05457803 is a clinical trial that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 396 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05457803 has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- 396 participants
- Enrollment target
Study Summary
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. Resea
Primary Outcome
To collect momentary assessments of individual instances of kratom use and effects associated with use (e.g., sleep duration, mood, motivations for use, acute effects, etc.) in daily life over 15 consecutive days among regular kratom users, for better understanding of kratom use in real-world contexts and in real time.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2022-12-15 |
What the finished NCT05457803 record still lists
NCT05457803 is an observational study that tracks outcomes without assigning an intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05457803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05457803 about?
NCT05457803 is a clinical study titled "Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology". 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 whi...
What is the current status of trial NCT05457803?
This trial is currently completed. The enrollment target is 396 participants. The study started on 2022-07-20. Estimated completion is 2022-12-15.
Who is sponsoring clinical trial NCT05457803?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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