Behavioral Pharmacology of THC and Beta-Myrcene

Обзор

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.

Подробное описание

The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, myrcene alone, THC and myrcene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and b-myrcene, two common constituents found in cannabis.

Вмешательства

• Препарат Placebo
  Placebo (ambient air)
• Препарат THC
  Pure THC vapor
• Препарат Beta-Myrcene
  Pure beta-myrcene vapor

Первичные конечные точки

• Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ) [Срок оценки: 6 hours]

Вторичные конечные точки (1)

• Self-reported "Tired/Sleepy" as assessed by the Drug Effect Questionnaire (DEQ) [Срок оценки: 6 hours]

Критерии участия

Критерии включения

• Have provided written informed consent
• Be between the ages of 18 and 55
• Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
• Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
• 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 clinic admission.
• Have a body mass index (BMI) in the range of 18 to 36 kg/m2
• Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
• Have no allergies to any of the ingredients used to prepare vapor (delta 9-THC, myrcene).
• Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score over 75).

Критерии исключения

• Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
• History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
• Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
• Use of a prescription medication (with the exception of birth control prescriptions) within 5 half-lives for that specific drug; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
• Cannabis use that is inconsistent with protocol requirements.
• Clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
• Individuals with anemia or who have donated blood in the prior 30 days

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 School of Medicine Behavioral Pharmacology Research Unit — Baltimore

Идентификаторы

NCT: NCT05432284 · IRB00329344 · R01DA043475

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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