Behavioral Pharmacology of THC and Beta-Myrcene
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
研究概览
简要总结
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.
详细描述
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.
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
placebo controlled, double blind
入排标准
- 年龄范围
- 18 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 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).
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo (ambient air)
干预措施: Placebo (Drug)
Vaporized high beta-myrcene
9mg of vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized low THC and low beta-myrcene
15mg vaporized THC with 2mg vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized high THC and low beta-myrcene
30mg vaporized THC with 2mg vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized high THC and high beta-myrcene
30mg vaporized THC with 9mg vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized low beta-myrcene
2mg of vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized low THC and high beta-myrcene
15mg vaporized THC with 9mg vaporized beta-myrcene
干预措施: Beta-Myrcene (Drug)
Vaporized high THC alone
30mg of vaporized pure THC
干预措施: THC (Drug)
Vaporized low THC and low beta-myrcene
15mg vaporized THC with 2mg vaporized beta-myrcene
干预措施: THC (Drug)
Vaporized low THC alone
15mg of vaporized pure THC
干预措施: THC (Drug)
Vaporized low THC and high beta-myrcene
15mg vaporized THC with 9mg vaporized beta-myrcene
干预措施: THC (Drug)
Vaporized high THC and low beta-myrcene
30mg vaporized THC with 2mg vaporized beta-myrcene
干预措施: THC (Drug)
Vaporized high THC and high beta-myrcene
30mg vaporized THC with 9mg vaporized beta-myrcene
干预措施: THC (Drug)
结局指标
主要结局
Self-reported Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
时间窗: 6 hours
Peak rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.
次要结局
- Self-reported "Tired/Sleepy" as assessed by the Drug Effect Questionnaire (DEQ)(6 hours)