The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cannabis
  Cannabis will be orally ingested
• Препарат Placebo
  Placebo will be orally ingested

Первичные конечные точки

• Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT) [Срок оценки: 8 hours]
• Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST) [Срок оценки: 8 hours]
• Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT) [Срок оценки: 8 hours]
• Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT) [Срок оценки: 8 hours]
• DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment [Срок оценки: 8 hours]
• DRUID application global impairment score - Acute behavioral impairment [Срок оценки: 8 hours]
• "Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ) [Срок оценки: 8 hours]
• "Want to take again" as assessed by the Drug Effect Questionnaire [Срок оценки: 8 hours]
• CMax for THC [Срок оценки: 8 hours]
• AUC for THC [Срок оценки: 8 hours]

Вторичные конечные точки (12)

• CMax for THC metabolite - 11-OH-THC [Срок оценки: 8 hours]
• CMax for THC metabolite- THCCOOH [Срок оценки: 8 hours]
• AUC for THC metabolite - 11-OH-THC [Срок оценки: 8 hours]
• AUC for THC metabolite - THCCOOH [Срок оценки: 8 hours]
• Tmax for THC [Срок оценки: 8 hours]
• Tmax for THC metabolite - 11-OH-THC [Срок оценки: 8 hours]
• Tmax for THC metabolite - THCCOOH [Срок оценки: 8 hours]
• Cmax for CBD [Срок оценки: 8 hours]
• Cmax for CBN [Срок оценки: 8 hours]
• Cmax for CBG [Срок оценки: 8 hours]
• AUC for CBD [Срок оценки: 8 hours]
• AUC for CBN [Срок оценки: 8 hours]

Критерии участия

Критерии включения

• Have provided written informed consent.
• Be between the ages of 21 and 55.
• 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/m2.
• Have not donated blood in the past 30 days.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore

Идентификаторы

NCT: NCT05602649 · IRB00354926 · 1R01DA057201-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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