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| ID | Type | Description | Link |
|---|---|---|---|
| R00DA055571 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute kratom exposure | Participants who regularly consume kratom will orally self-administer a single serving of the participants commercial kratom product under direct observation in order to evaluate acute physiological, subjective, and cognitive effects and determine pharmacokinetics. This will occur during the first 24 hours of study participation. Participants will undergo direct observation and assessment for after ceasing all kratom product use. Physiological, subjective, and cognitive effects during this supervised withdrawal will be assessed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effects from acute kratom exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak subjective opioid withdrawal score | 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. | Up to 3 days |
| Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached | 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. | up to 3 days |
| Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome) | 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. | Up to 3 days |
| Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome) | 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. | Up to 3 days |
| Changes in accuracy on psychomotor task (primary cognitive outcome) | 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. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Healthy adults aged 21 or older who use kratom.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten E Smith, Ph.D. | Contact | 865-418-8177 | ksmit398@jh.edu | |
| Naftali Zeilinger, B.A. | Contact | 410-550-0490 | nzeilin1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten E Smith, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21224 | United States |
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Human urine; plasma
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| Up to 3 days |
| Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome). | 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 | Up to 3 days |