Behavioral Pharmacology of THC and Alpha-pinene
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Mean Peak Change From Baseline 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 alpha-pinene 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 6 acute drug administration periods in which they will administer THC alone, pinene alone, THC and pinene together, or placebo. Subjective drug effects, cognitive performance, and vital signs will be assessed following drug administration. Each participant will receive all 6 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help the investigators understand the individual and interactive effects of THC and pinene, 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, 12-lead ECG 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 (THC, pinene).
- •Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score of 75/90).
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 over-the-counter (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 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 dronabinol (Marinol®) within the past month.
- •Average use of cannabis more than 2 times per week in the prior 3 months.
- •History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- •Abnormal EKG result that in the investigator's opinion is clinically significant.
- •Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- •Having previously sought medical attention to manage adverse effects following acute cannabis use.
- •Individuals with anemia or who have donated blood in the prior 30 days
研究组 & 干预措施
Placebo
Placebo (5mL distilled water)
干预措施: Placebo (Drug)
Vaporized Pinene
15mg vaporized alpha-pinene
干预措施: Alpha-Pinene (Drug)
Vaporized THC
30mg vaporized delta-9-THC
干预措施: THC (Drug)
Vaporized THC and low alpha-pinene
30mg vaporized delta-9-THC and 0.5mg of vaporized alpha-pinene
干预措施: THC (Drug)
Vaporized THC and low alpha-pinene
30mg vaporized delta-9-THC and 0.5mg of vaporized alpha-pinene
干预措施: Alpha-Pinene (Drug)
Vaporized THC and alpha-pinene
30mg vaporized delta-9-THC and 5mg of vaporized alpha-pinene
干预措施: THC (Drug)
Vaporized THC and alpha-pinene
30mg vaporized delta-9-THC and 5mg of vaporized alpha-pinene
干预措施: Alpha-Pinene (Drug)
Vaporized THC and high alpha-pinene
30mg vaporized delta-9-THC and 15mg of vaporized alpha-pinene
干预措施: THC (Drug)
Vaporized THC and high alpha-pinene
30mg vaporized delta-9-THC and 15mg of vaporized alpha-pinene
干预措施: Alpha-Pinene (Drug)
结局指标
主要结局
Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
时间窗: 0-6 hours, assessed at baseline, 0-hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Mean Peak change from baseline rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
时间窗: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
时间窗: 0-6 hours, assessed at baseline, 0-hour, and 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post dosing.
Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
次要结局
未报告次要终点