Kratom, Kratom Pharmacodynamics, Kratom Pharmacokinetics
Conditions
Keywords
kratom
Brief summary
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.
Interventions
BEHAVIORALEffects from acute kratom exposure
Participants who regularly use commercial Kratom products will orally consume a known quantity of kratom under direct observation on first study day; following this, participants will stop kratom use for approximately 2 nights and 2.5 days for the duration of the study.
Sponsors
Johns Hopkins University
University of Florida
National Institute on Drug Abuse (NIDA)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. \>21 years 2. reporting kratom use \>5 times per week for \>3 months prior to study screening 3. English language proficiency 4. Willingness to provide requested samples of the kratom product being currently taken
Exclusion criteria
1. Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening 2. Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product. 3. Cannot or will not provide kratom product samples in the form of an unopened package of kratom that is clearly labeled with at least the product and vendor name. 4. Self-reports using kratom products by any other route than orally swallowing. 5. Current physical dependence on alcohol, benzodiazepines, or opioids 6. Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen. 7. Discordance between self-reported substance use and drug screen results obtained during screening. 8. Lifetime or current psychotic disorder 9. Current untreated major depressive or bipolar disorder 10. Pregnancy or nursing 11. Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak subjective opioid withdrawal score | Up to 3 days | Peak score on the Subjective Opioid Withdrawal Scale (SOWS); that occurs between Study Days 1-3. Score range 0-64. 5-point scale of intensity: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. Higher score indicates higher intensity. SOWS will be administered at 8 time points on Study Days 1-2 and 7 time points on Study Day 3. |
| Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached | up to 3 days | Time, in minutes, until at least a moderate score (of 11 or higher) is reached on the Subjective Opioid Withdrawal Scale (SOWS). SOWS will be administered at 8 time points on Study Days 1-2 and 7 time points on Study Day 3. 5-point scale of intensity: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. Score range 0-64. Higher score indicates higher intensity. |
| Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome) | Up to 3 days | Drug Effects Questionnaire (DEQ) visual analogue scale (0-100) rating for DEQ item "feeling high." The DEQ will be administered at 7 timepoints on Study Day 1 and at 6 times points on Study Days 2 and 3. |
| Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome) | Up to 3 days | Drug Effects Questionnaire (DEQ) visual analogue scale (0-100) rating for DEQ item "drug liking." The DEQ will be administered at 7 time points on Study Day 1 and at 6 times points on Study Days 2 and 3. |
| Changes in accuracy on psychomotor task (primary cognitive outcome) | Up to 3 days | The 2-minute computerized Digit Symbol Substitution Task (DSST) outcome of total number of correct responses (accuracy) within the 2-minute test window. This will evaluate cognitive performance and impairment. The DSST will be administered at 7 time points on Study Day 1 and at 6 times points on Study Days 2 and 3. |
| Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome). | Up to 3 days | Pupil diameter in mm under stable light conditions using a pupilometer. Pupil size will be measured at 8 timepoints on Study Days 1 and 2 and at 7 timepoints on Study Day 3 |
Countries
United States
Contacts
CONTACTKirsten E Smith, Ph.D.
CONTACTNaftali Zeilinger, B.A.
PRINCIPAL_INVESTIGATORKirsten E Smith, Ph.D.
Johns Hopkins University
Outcome results
None listed