Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Mood Scale - Subscale 'Feeling High'
研究概览
简要总结
The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.
详细描述
Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC. Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically produced cannabidiol is given to healthy marijuana users in this study to test its capability to reduce the high of THC and, thereby, help to relieve addiction to marijuana.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 18 and
- •Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
- •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, repeated illicit drug use other than marijuana
- •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
研究组 & 干预措施
Active marijuana (MJ) with 0 mg CBD
Active MJ cigarettes contain 5.30% THC
干预措施: CBD (Drug)
Active MJ with 200 mg CBD
Active MJ cigarettes contain 5.30% THC
干预措施: CBD (Drug)
Active MJ with 400 mg CBD
Active MJ cigarettes contain 5.30% THC
干预措施: CBD (Drug)
Active MJ with 800 mg CBD
Active MJ cigarettes contain 5.30% THC
干预措施: CBD (Drug)
Inactive MJ with 0 mg CBD
Inactive MJ cigarettes contain 0.01% THC
干预措施: CBD (Drug)
Inactive MJ with 200 mg CBD
Inactive MJ cigarettes contain 0.01% THC
干预措施: CBD (Drug)
Inactive MJ with 400 mg CBD
Inactive MJ cigarettes contain 0.01% THC
干预措施: CBD (Drug)
Inactive MJ with 800 mg CBD
Inactive MJ cigarettes contain 0.01% THC
干预措施: CBD (Drug)
结局指标
主要结局
Mood Scale - Subscale 'Feeling High'
时间窗: two hours before and after marijuana cigarette smoking
Participants rated how much they felt having a "high" feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely).
次要结局
未报告次要终点