The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
研究概览
简要总结
This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.
详细描述
The purpose of this study is to examine the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 popular types of cannabis edibles: THC-infused chocolates, gummies, and drinks. This study will utilize a rigorous double-blind, placebo-controlled, within-subjects design. Healthy adults (N=40; 20 males, 20 females) will complete 9 outpatient drug administration sessions in a randomized order. After 8 hours of monitored fasting, participants will consume 1 of 3 types of edibles (chocolates, gummies, or drinks) that are representative of current retail cannabis products. Products will contain 0 (placebo), 10, or 25mg THC. PD assessments include a battery of cognitive/psychomotor performance tasks shown to be sensitive to oral cannabis at these doses and subjective drug effects. Blood samples will be drawn to measure THC and its primary metabolites. Vital signs will be recorded. These procedures will be completed during each of the 9 study sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind, placebo controlled
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have provided written informed consent.
- •Be between the ages of 21 and
- •Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
- •Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
- •Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.
- •Have prior experience using THC-dominant cannabis.
- •Have a body mass index (BMI) in the range of 16 to 38 kg/m
- •Have not donated blood in the past 30 days.
排除标准
- •Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.
- •History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
- •Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.
- •History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.
- •Evidence of current psychiatric condition (based on MINI for DSM-5).
- •Been in treatment previously for cannabis use disorder.
- •Receiving of any drug as part of a research study within the past 30 days.
- •History of epilepsy or other serious medical condition.
研究组 & 干预措施
Low Dose Gummy
Participants will self-administer a gummy containing 10mg THC
干预措施: Cannabis (Drug)
High Dose Gummy
Participants will self-administer a gummy containing 25mg THC
干预措施: Cannabis (Drug)
Low Dose Chocolate
Participants will self-administer chocolate containing 10mg THC
干预措施: Cannabis (Drug)
Placebo Gummy
Participants will self-administer a gummy containing 0mg THC
干预措施: Placebo (Drug)
Placebo Chocolate
Participants will self-administer chocolate containing 0mg THC
干预措施: Placebo (Drug)
Placebo Beverage
Participants will self-administer a beverage containing 0mg THC
干预措施: Placebo (Drug)
High Dose Chocolate
Participants will self-administer chocolate containing 25mg THC
干预措施: Cannabis (Drug)
High Dose Beverage
Participants will self-administer a beverage containing 25mg THC
干预措施: Cannabis (Drug)
Low Dose Beverage
Participants will self-administer a beverage containing 10mg THC
干预措施: Cannabis (Drug)
结局指标
主要结局
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
时间窗: 8 hours
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (lower scores indicate worse performance).
DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment
时间窗: 8 hours
Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
时间窗: 8 hours
Computerized version of the Divided Attention Task will be administered to assess attention. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
时间窗: 8 hours
Computerized version of the Divided Attention Task will be administered to assess executive functioning. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
DRUID application global impairment score - Acute behavioral impairment
时间窗: 8 hours
Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
"Want to take again" as assessed by the Drug Effect Questionnaire
时间窗: 8 hours
The DEQ will be used to obtain subjective ratings of "want to take drug again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
AUC for THC
时间窗: 8 hours
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)
时间窗: 8 hours
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90 seconds is primary outcome (lower scores indicate worse performance).
CMax for THC
时间窗: 8 hours
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
时间窗: 8 hours
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
次要结局
- Tmax for THC metabolite - 11-OH-THC(8 hours)
- Cmax for CBN(8 hours)
- CMax for THC metabolite - 11-OH-THC(8 hours)
- AUC for THC metabolite - 11-OH-THC(8 hours)
- Tmax for THC metabolite - THCCOOH(8 hours)
- Cmax for CBG(8 hours)
- CMax for THC metabolite- THCCOOH(8 hours)
- AUC for CBD(8 hours)
- Tmax for CBD(8 hours)
- AUC for THC metabolite - THCCOOH(8 hours)
- Tmax for THC(8 hours)
- Cmax for CBD(8 hours)
- AUC for CBN(8 hours)
- Tmax for CBG(8 hours)
- Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)(8 hours)
- "Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire(8 hours)
- Tmax for CBN(8 hours)
- Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)(8 hours)
- "Feel Drug Effect" as assessed by the Drug Effect Questionnaire-(8 hours)
- AUC for CBG(8 hours)
- Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)(8 hours)
- Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)(8 hours)