Chronic PainNCT05457803
Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology
An observational study of Chronic Pain and Fatigue, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Fatigue, Substance Use Disorders
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Main EMA Study the subjects will be selected online form subjects who use kratom ( Target 240 completers). For the In-person Substudy (target 10 subjects) we will select online or local form subjects who use kratom.
Who may be able to join
- For the Main EMA Study
- Regular kratom use.
- Passing data validity checks on the online screening questionnaire.
- Reporting ownership of a smartphone.
- Age >= 18 years.
- Currently residing in the US .
Show all 12Show fewer
- Willingness to complete all study activities as described in the online study preamble and informed consent, including willingness to provide a small sample of their kratom product.
- Passing online Main Study consent quiz with at least 8/10 correct answers.
- English language proficiency.
- Not incarcerated.
- Additional inclusion criterion for the In-person Substudy:
- -Residing in or near MD.
Who cannot join
- For the Main EMA Study
- Missing data validity checks on screening questionnaire
- Decisionally impaired adults..
- Additional exclusion criterion for the In-person Substudy:
- Pregnancy by urine test.
- Self-reported proneness to experiencing motion sickness or feelings of vertigo. This is a precaution, because motion sickness could interfere with the task or cause discomfort.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
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.
Read more
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....
Read the detailed description
Study Description:
Our natural-history study will build on preliminary research on the use and effects of kratom. We propose to examine momentary reasons for and self-reported effects of kratom-product use in daily life, associations of these findings with product alkaloid content and, in a direct-observation setting, externally observable effects of kratom-product use.
In the Main EMA Study, to be conducted nationwide via online/mobile data collection, we will examine instances of kratom use in naturalistic settings using EMA, and we will characterize the alkaloid content of the products used. The target sample size is 240 completers.
In the In-person Substudy, 10 participants who reside near the NIDA IRP will conduct the same activities as in the Main EMA Study (online questionnaires, then EMA for 15 days), plus a one-day outpatient session. On the session day, we will collect physiological and task-derived measures (these will include a driving-simulation task) after the participants have taken their regular kratom product dose. This will be followed by semi-structured narrative qualitative interviews.
Objectives for the Main EMA Study:
Primary objective: 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 days among regular kratom users, for better understanding kratom use in real-world contexts and in real time.
Secondary objective: to determine associations of momentary responses with directly assayed content of samples of participants kratom products.
Exploratory objectives: to evaluate whether retrospective self-report on cross-sectional questionnaires completed prior to EMA correlate with momentary self-report (e.g., do people who report using kratom primarily for pain actually report self-treatment of pain symptoms as a proximal motivation?). A second exploratory objective is to determine whether there are subgroups of participants who share distinct patterns of kratom use.
Objectives for the In-Person Substudy:
Primary objective: to evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Secondary objective: to gather comprehensive narrative case-report data via qualitative interviewing.
Exploratory objectives include: First, to assess vital signs, pupil size, and psychomotor performance of participants prior to their taking their regular kratom dose and at repeated intervals subsequent to their taking their regular kratom product dose (4-6 total time points). Second, to measure signs of opioid withdrawal among participants prior to their taking their regular kratom dose and after (4 total time points). Third, to measure participants performance on a driving simulation before they have taken their kratom dose and after they have taken their kratom dose (2 time points total).
Endpoints for Main EMA Study:
For primary objectives: proximal motivations for use; somatic and psychoactive effects reported from use; associations between self-reported states (e.g., mood, pain, craving), and particular kratom product types reported as being used; associations between self-reported states (e.g., mood, pain, craving) and kratom dose.
For secondary objectives: quantification of up to 14 kratom alkaloids; differences in alkaloid content by kratom product type (e.g., extract, raw plant matter); differences in alkaloid content by kratom vendor type (e.g., small online vendor, large-scale importer and distributor; between-person correlations (self-reported momentary effects and alkaloid levels).
For exploratory objectives: correlation of cross-sectional self-reported kratom use motivations and momentary (proximate) kratom use motivations; Cluster analysis of kratom use patterns.
Endpoints for In-person Substudy:
For primary objectives: Concentrations of detectable kratom alkaloids and their metabolites in human plasma and urine; differences in concentrations by kratom product type (e.g., extract, raw plant matter); Addiction Research Center Inventory and other self-report questionnaires.
For secondary objective: narrative case report series documenting participant s kratom use, from initiation to present day.
For exploratory objectives: Psychomotor performance; Resting vitals; Pupil size; Subjective Opioid Withdrawal Scale; Driving-simulation performance.
- Conditions
- Chronic Pain, Fatigue, Substance Use Disorders
- Keywords
- Alkaloid Content, Mitragyna Speciosa, Mitragynine, 7-Hydroxymitragynine, Corynoxine, Speciociliatine, As Serotonergic, Dopaminergic, Adrenergic, And Adenosinergic Receptors, Natural History
- Medical subject headings
- Chronic Pain, Fatigue, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-persom kratom users | 10 subjects that use kratom an additional cross-sectional evaluation: one session day at the NIDA IRP preceded by a consent session day; 2 visits at our BRC building total. | |
| Online kratom users | 240 subjects that use kratom, prospective observational cohort study in which each participant provides intensive longitudinal data on kratom use for 15 consecutive days via smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
motivations for use of kratom
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.
Measured: End of study
Differences in concentrations by kratom product type
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Measured: End of study
Associations between self-reported states and particular kratom product types reported as being used.
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.
Measured: End of study
Somatic and psychoactive effects reported from use of kratom
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.
Measured: End of study
Associations between self-reported states and kratom dose
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.
Measured: End of study
Detect Concentrations of detectable kratom alkaloids and their metabolites in human plasma and urine.
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Measured: End of study
Complete addiction Research Center Inventory (ARCI).
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Measured: End of study
Secondary outcomes (8)
Evaluate Psychomotor performance, Resting vitals, Pupil size, Drug Effects Questionnaire, Subjective Opioid Withdrawal Scale (SOWS), Driving-simulation performance.
To assess vital signs, pupil size, and psychomotor performance prior to their taking their regular kratom dose and at repeated intervals subsequent to their taking their regular kratom dose (4-6 total time points). To measure signs of opioid withdrawal among participants prior to their taking their regular kratom dose and after (6 total time points). To measure participants performance on a driving simulation before they have taken their kratom dose and after they have taken their kratom dose (2-time points total).
Measured: End of study
Correlation of cross-sectional self-reported kratom use motivations and momentary (proximate) kratom use motivations.
To evaluate whether retrospective self-report on cross-sectional questionnaires completed prior to EMA correlate with momentary self-report (e.g., do people who retrospectively report using kratom primarily for pain actually report self-treatment of pain symptoms as a proximate motivation?). To determine if there are subgroups of kratom user within the larger sample
Measured: End of study
Quantification of up to 14 kratom alkaloids
To determine associations of momentary responses with directly assayed content of samples of participants kratom products.
Measured: End of study
Use-pattern clusters
To evaluate whether retrospective self-report on cross-sectional questionnaires completed prior to EMA correlate with momentary self-report (e.g., do people who retrospectively report using kratom primarily for pain actually report self-treatment of pain symptoms as a proximate motivation?). To determine if there are subgroups of kratom user within the larger sample
Measured: End of study
Between-person correlations (self-reported momentary effects and alkaloid levels).
To determine associations of momentary responses with directly assayed content of samples of participants kratom products
Measured: End of study
Narrative case report series documenting participants kratom use, from initiation to present day
To gather comprehensive narrative case report from participants via qualitative interviewing.
Measured: End of study
Differences in alkaloid content by kratom vendor type
To determine associations of momentary responses with directly assayed content of samples of participants kratom products
Measured: End of study
Differences in alkaloid content by kratom product type
To determine associations of momentary responses with directly assayed content of samples of participants kratom products.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start20 Jul 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David H Epstein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457803
- Sponsor's protocol ID
- 10000910
- Other IDs
- 000910-DA
- Status last verified
- 2 Jul 2025
- First submitted
- 13 Jul 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berthold EC, Kamble SH, Raju KS, King TI, Popa R, Sharma A, Leon F, Avery BA, McMahon LR, McCurdy CR. Preclinical pharmacokinetic study of speciociliatine, a kratom alkaloid, in rats using an UPLC-MS/MS method. J Pharm Biomed Anal. 2021 Feb 5;194:113778. doi: 10.1016/j.jpba.2020.113778. Epub 2020 Nov 21.
PubMed 33277117Anwar M, Law R, Schier J. Notes from the Field: Kratom (Mitragyna speciosa) Exposures Reported to Poison Centers - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Jul 29;65(29):748-9. doi: 10.15585/mmwr.mm6529a4.
PubMed 27466822Babu KM, McCurdy CR, Boyer EW. Opioid receptors and legal highs: Salvia divinorum and Kratom. Clin Toxicol (Phila). 2008 Feb;46(2):146-52. doi: 10.1080/15563650701241795.
PubMed 18259963
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Momentary Assessment of Kratom Use Accompanied by Product Assays: A Natural-history Study for Interdisciplinary Characterization of Kratom Use and Pharmacology
- ClinicalTrials.gov ID
- NCT05457803
- Acronym / sponsor ID
- 10000910
- Conditions
- Chronic Pain, Fatigue, Substance Use Disorders
- Keywords
- Alkaloid Content, Mitragyna Speciosa, Mitragynine, 7-Hydroxymitragynine, Corynoxine, Speciociliatine, As Serotonergic, Dopaminergic, Adrenergic, And Adenosinergic Receptors, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Study Description:
Our natural-history study will build on preliminary research on the use and effects of kratom. We propose to examine momentary reasons for and self-reported effects of kratom-product use in daily life, associations of these findings with product alkaloid content and, in a direct-observation setting, externally observable effects of kratom-product use.
In the Main EMA Study, to be conducted nationwide via online/mobile data collection, we will examine instances of kratom use in naturalistic settings using EMA, and we will characterize the alkaloid content of the products used. The target sample size is 240 completers.
In the In-person Substudy, 10 participants who reside near the NIDA IRP will conduct the same activities as in the Main EMA Study (online questionnaires, then EMA for 15 days), plus a one-day outpatient session. On the session day, we will collect physiological and task-derived measures (these will include a driving-simulation task) after the participants have taken their regular kratom product dose. This will be followed by semi-structured narrative qualitative interviews.
Objectives for the Main EMA Study:
Primary objective: 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 days among regular kratom users, for better understanding kratom use in real-world contexts and in real time.
Secondary objective: to determine associations of momentary responses with directly assayed content of samples of participants kratom products.
Exploratory objectives: to evaluate whether retrospective self-report on cross-sectional questionnaires completed prior to EMA correlate with momentary self-report (e.g., do people who report using kratom primarily for pain actually report self-treatment of pain symptoms as a proximal motivation?). A second exploratory objective is to determine whether there are subgroups of participants who share distinct patterns of kratom use.
Objectives for the In-Person Substudy:
Primary objective: to evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Secondary objective: to gather comprehensive narrative case-report data via qualitative interviewing.
Exploratory objectives include: First, to assess vital signs, pupil size, and psychomotor performance of participants prior to their taking their regular kratom dose and at repeated intervals subsequent to their taking their regular kratom product dose (4-6 total time points). Second, to measure signs of opioid withdrawal among participants prior to their taking their regular kratom dose and after (4 total time points). Third, to measure participants performance on a driving simulation before they have taken their kratom dose and after they have taken their kratom dose (2 time points total).
Endpoints for Main EMA Study:
For primary objectives: proximal motivations for use; somatic and psychoactive effects reported from use; associations between self-reported states (e.g., mood, pain, craving), and particular kratom product types reported as being used; associations between self-reported states (e.g., mood, pain, craving) and kratom dose.
For secondary objectives: quantification of up to 14 kratom alkaloids; differences in alkaloid content by kratom product type (e.g., extract, raw plant matter); differences in alkaloid content by kratom vendor type (e.g., small online vendor, large-scale importer and distributor; between-person correlations (self-reported momentary effects and alkaloid levels).
For exploratory objectives: correlation of cross-sectional self-reported kratom use motivations and momentary (proximate) kratom use motivations; Cluster analysis of kratom use patterns.
Endpoints for In-person Substudy:
For primary objectives: Concentrations of detectable kratom alkaloids and their metabolites in human plasma and urine; differences in concentrations by kratom product type (e.g., extract, raw plant matter); Addiction Research Center Inventory and other self-report questionnaires.
For secondary objective: narrative case report series documenting participant s kratom use, from initiation to present day.
For exploratory objectives: Psychomotor performance; Resting vitals; Pupil size; Subjective Opioid Withdrawal Scale; Driving-simulation performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-persom kratom users | – | –10 subjects that use kratom an additional cross-sectional evaluation: one session day at the NIDA IRP preceded by a consent session day; 2 visits at our BRC building total. |
| Online kratom users | – | –240 subjects that use kratom, prospective observational cohort study in which each participant provides intensive longitudinal data on kratom use for 15 consecutive days via smartphone app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Main EMA Study the subjects will be selected online form subjects who use kratom ( Target 240 completers). For the In-person Substudy (target 10 subjects) we will select online or local form subjects who use kratom.
Key inclusion criteria (12 listed)
- For the Main EMA Study
- Regular kratom use.
- Passing data validity checks on the online screening questionnaire.
- Reporting ownership of a smartphone.
- Age >= 18 years.
Key exclusion criteria (6 listed)
- For the Main EMA Study
- Missing data validity checks on screening questionnaire
- Decisionally impaired adults..
- Pregnancy by urine test.
- Self-reported proneness to experiencing motion sickness or feelings of vertigo. This is a precaution, because motion sickness could interfere with the task or cause discomfort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motivations for use of kratom
Time frame: End of study
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.
Differences in concentrations by kratom product type
Time frame: End of study
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Associations between self-reported states and particular kratom product types reported as being used.
Time frame: End of study
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.
Somatic and psychoactive effects reported from use of kratom
Time frame: End of study
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.
Associations between self-reported states and kratom dose
Time frame: End of study
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.
Detect Concentrations of detectable kratom alkaloids and their metabolites in human plasma and urine.
Time frame: End of study
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
Complete addiction Research Center Inventory (ARCI).
Time frame: End of study
To evaluate the relationships among subjective self-reported kratom effects (measured over 3 hours post-dosing), the kratom product used, and kratom alkaloid concentrations in biospecimens.
8 secondary outcomes
Evaluate Psychomotor performance, Resting vitals, Pupil size, Drug Effects Questionnaire, Subjective Opioid Withdrawal Scale (SOWS), Driving-simulation performance.
Time frame: End of study
Correlation of cross-sectional self-reported kratom use motivations and momentary (proximate) kratom use motivations.
Time frame: End of study
Quantification of up to 14 kratom alkaloids
Time frame: End of study
Use-pattern clusters
Time frame: End of study
Between-person correlations (self-reported momentary effects and alkaloid levels).
Time frame: End of study
Narrative case report series documenting participants kratom use, from initiation to present day
Time frame: End of study
Differences in alkaloid content by kratom vendor type
Time frame: End of study
Differences in alkaloid content by kratom product type
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 33277117Berthold EC, Kamble SH, Raju KS, King TI, Popa R, Sharma A, Leon F, Avery BA, McMahon LR, McCurdy CR. Preclinical pharmacokinetic study of speciociliatine, a kratom alkaloid, in rats using an UPLC-MS/MS method. J Pharm Biomed Anal. 2021 Feb 5;194:113778. doi: 10.1016/j.jpba.2020.113778. Epub 2020 Nov 21.
- Background: PubMed 27466822Anwar M, Law R, Schier J. Notes from the Field: Kratom (Mitragyna speciosa) Exposures Reported to Poison Centers - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Jul 29;65(29):748-9. doi: 10.15585/mmwr.mm6529a4.
- Background: PubMed 18259963Babu KM, McCurdy CR, Boyer EW. Opioid receptors and legal highs: Salvia divinorum and Kratom. Clin Toxicol (Phila). 2008 Feb;46(2):146-52. doi: 10.1080/15563650701241795.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Epstein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Fatigue, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motivations for use of kratom (time frame: End of study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.