Characterization of the Analgesic Effects of Oral CBD in Healthy, Normal Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
研究概览
简要总结
The purpose of this double-blind, placebo-controlled study is to determine the analgesic effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics.
详细描述
This within-subject, double-blind, placebo-controlled study will assess the analgesic and subjective effects of a range of CBD doses (0, 200, 400, or 800 mg, po). Volunteers will participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of analgesics. The order of CBD dose will be randomized across participants. Secondary measures will include subjective and physiologic effects of CBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to perform study procedures
- •Women practicing an effective form of birth control
排除标准
- •Female subjects who are currently pregnant or breastfeeding.
- •Current illicit drug use
- •Presence of significant medical illness
- •History of heart disease
- •Request for drug treatment
- •Current parole or probation
- •Recent history of significant violent behavior
- •Major psychiatric disorder
- •Current use of any prescription or over-the-counter medication
- •Current pain
- •Clinically significant Raynaud's syndrome
研究组 & 干预措施
Active CBD
Each subject will receive each active dose of cannabidiol, one active dose per 3 of the 4 study days. The active cannabidiol doses include 200, 400 and 800 mg of cannabidiol.
干预措施: Cannabidiol (Drug)
Placebo
On 1 of the 4 study days, participants will receive placebo cannabidiol (0 mg)
干预措施: Placebo (Drug)
结局指标
主要结局
Analgesia: Change From Baseline in Pain Tolerance and Threshold as Measured by the Cold Pressor Test
时间窗: Baseline, 60 minutes, 120 minutes 180 minutes, 240 minutes, 300 minutes and 360 minutes after each dose
Time to first feel pain ("Pain threshold" measured in seconds) during the Cold Pressor Test and withdraw the hand from the cold water ("Pain Tolerance" measured in seconds). Changes in threshold from baseline were averaged across study sessions for each CBD dose.
次要结局
- Subjective Drug Effects Related to Abuse Liability as Measured by Visual Analog Scales(30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 270 minutes, 300 minutes, 330 minutes, 360 minutes)
研究者
Ziva D. Cooper, PhD
Associate Professor of Clinical Neurobiology (in Psychiatry)
University of California, Los Angeles