Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached
研究概览
简要总结
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:
- 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?
- What are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly?
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •reporting kratom use >5 times per week for >3 months prior to study screening
- •English language proficiency
- •Willingness to provide requested samples of the kratom product being currently taken
排除标准
- •Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening
- •Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product.
- •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.
- •Self-reports using kratom products by any other route than orally swallowing.
- •Current physical dependence on alcohol, benzodiazepines, or opioids
- •Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen.
- •Discordance between self-reported substance use and drug screen results obtained during screening.
- •Lifetime or current psychotic disorder
- •Current untreated major depressive or bipolar disorder
- •Pregnancy or nursing
- •Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).
研究组 & 干预措施
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.
干预措施: Effects from acute kratom exposure (Behavioral)
结局指标
主要结局
Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached
时间窗: 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 subjective opioid withdrawal score
时间窗: 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.
Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome)
时间窗: 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.
Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome).
时间窗: 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
Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome)
时间窗: 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.
Changes in accuracy on psychomotor task (primary cognitive outcome)
时间窗: 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.
次要结局
未报告次要终点