Interactions Between Delta-9-THC and CBD: A Controlled Human Drug-administration Study Probing a Harm Reduction Strategy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subject-rated drug effects of abuse liability
研究概览
简要总结
The purpose of this research is to assess the impact of CBD on the effects of THC.
详细描述
Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.
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, Investigator)
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
- •Male or non-pregnant and non-lactating females aged 21-55 years
- •Report cannabis use 1-7 days per week over the month prior to screening
- •Not currently seeking treatment for their cannabis use
- •History of inhaled cannabis use
- •Have a Body Mass Index from 18.5 - 34 kg/m2
- •Able to perform all study procedures
- •Must be using a contraceptive (hormonal or barrier methods)
排除标准
- •Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
- •Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
- •Report using other illicit drugs in the prior 4 weeks
- •Current pain
- •Pregnancy
- •Currently enrolled in another research protocol
- •Not using a contraceptive method (hormonal or barrier methods)
- •Insensitivity to the cold water stimulus of the Cold Pressor Test
- •Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
- •Not able to speak and read English
研究组 & 干预措施
Placebo
0 mg THC, 0 mg CBD
干预措施: Placebo (Drug)
THC
20 mg THC, 0 mg CBD
干预措施: THC (Drug)
CBD 20
0 mg THC, 20 mg CBD
干预措施: CBD 20 mg (Drug)
CBD 40
0 mg THC, 40 mg CBD
干预措施: CBD 40 mg (Drug)
CBD 80
0 mg THC, 80 mg CBD
干预措施: CBD 80 mg (Drug)
THC with CBD 20
20 mg THC, 20 mg CBD
干预措施: THC (Drug)
THC with CBD 20
20 mg THC, 20 mg CBD
干预措施: CBD 20 mg (Drug)
THC with CBD 40
20 mg THC, 40 mg CBD
干预措施: THC (Drug)
THC with CBD 40
20 mg THC, 40 mg CBD
干预措施: CBD 40 mg (Drug)
THC with CBD 80
20 mg THC, 80 mg CBD
干预措施: THC (Drug)
THC with CBD 80
20 mg THC, 80 mg CBD
干预措施: CBD 80 mg (Drug)
结局指标
主要结局
Subject-rated drug effects of abuse liability
时间窗: 3 hours
Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)
Analgesia as measured using the Cold Pressor Test
时间窗: 3 hours
Pain threshold assessed using the Cold Pressor Test (percent baseline)
Behavioral task performance as assessed by the DRUID App Score
时间窗: 3 hours
Trough composite scores on the DRUID App
Pharmacokinetics of THC
时间窗: 3 hours
Peak plasma levels of THC (ng/ml)
次要结局
未报告次要终点
研究者
Ziva D. Cooper, PhD
Professor
University of California, Los Angeles