Determination of Cannabinoid and Cannabinoid Metabolite Levels in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Amount of THC-COOH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
研究概览
简要总结
Levels of major cannabinoid and cannabinoid metabolites (i.e., CBD, CBD-OH) will be determined in the plasma of healthy volunteers following 10 days of Happy Lane Hemp Extract/CBD soft gels (25 mg per capsule) supplementation using liquid chromatography-mass spectrometry (LCMS).
详细描述
The objective of the study is to determine the levels of CBD, CBD-OH, THC, THC-COOH, and 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days.
The research team is planning to recruit 24 adults (12 females, 12 males), age of 18-45 years old, inclusive to allow for enrollment of 20 eligible adults (10 females, 10 males). Subjects will be identified and recruited using AR Research via the UAMS Translational Research Institute (TRI). Specifically, TRI coordinators will assist with calling, screening, and scheduling potential subjects based on the list generated from AR Research.
After signing the informed consent form, which includes an attestation that the subject has not used cannabinoids within the past 4 weeks and an attestation that the subject will not use any prescription or over-the-counter medications during the study, each subject will provide a baseline plasma sample (up to 15 mL, collected by TRI coordinators) that will be used to determine if any cannabinoids (CBD, CBD-OH, THC, THC-COOH, and 11-OH-THC) are present in the blood.
All blood samples (pre- and post-intervention) will be analyzed at the completion of the study. Therefore, if cannabinoids are found in any of the baseline samples, the result will be noted but will not necessarily result in any subjects being excluded from the study. However, exclusion of data from subjects whose initial test show a positive result for CBD or THC from the overall study may be deemed necessary by the research team under certain circumstances (e.g., if the baseline THC and/or CBD signal in a study subject is so large that accurate detection of the intervention would be hindered).
After the informed consent form is signed and the baseline plasma sample is drawn, each subject will be provided with Happy Lane™ Hemp Extract/CBD soft gels (25 mg CBD per capsule; the certificate of analyses is provided along with this Study Protocol). Half of the subjects (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose, both capsules will be taken at the same time). Group assignment will be made randomly based on a computer-generated randomization list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females, between 18- and 45-years old, inclusive
- •Ability to provide consent for oneself, including:
- •Attestation not to use other cannabinoid-containing product(s) throughout the duration of the study
- •Attestation not to use prescription or over the counter medication(s) and/or supplements throughout the duration of the study
排除标准
- •Self-reported use of any cannabinoids (i.e., CBD, THC) within the last 4 weeks.
- •Use of any prescription (or over the counter) medication or supplements during the study or in the 24 hours before enrollment in the study
- •Serious illness (e.g., abnormal liver or kidney function, cardiovascular disease, diabetes, etc.)
- •Any other condition that in the opinion of the investigator might interfere with the safe conduct of the study
结局指标
主要结局
Amount of THC-COOH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
时间窗: 13 days
Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of THC-COOH in the plasma samples.
Amount of THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
时间窗: 13 days
Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of THC in the plasma samples.
Amount of CBD in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
时间窗: 13 days
Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of CBD in the plasma samples.
Amount of 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
时间窗: 13 days
Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of 11-OH-THC in the plasma samples.
Amount of CBD-OH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
时间窗: 13 days
Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of CBD-OH in the plasma samples.
次要结局
未报告次要终点