Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
研究概览
简要总结
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.
详细描述
To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least one lifetime exposure to cannabis
- •Good physical and mental health
排除标准
- •Cannabis naive individuals
- •Major current or recent stressors
- •Taking estrogen supplements or oral contraceptive pills (for women)
- •Sesame oil allergy
研究组 & 干预措施
THC
10 mg Dronabinol will be administered orally.
干预措施: Dronabinol (Drug)
Placebo
Placebo pill (no active cannabinoids).
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
时间窗: baseline and +80 minutes after start of oral Dronabinol administration.
Measured as delay recall on the AVLT
Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
时间窗: changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.
Subjective measure of THC induced "high"
次要结局
未报告次要终点
研究者
Mohini Ranganathan
Assistant Professor of Psychiatry
Yale University