Sex-dependent Effects of Cannabis: Assessing Analgesic, Abuse-related and Pharmacokinetic Differences Between Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of THC and metabolites
研究概览
简要总结
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women
详细描述
The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.
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 female aged 21-55 years
- •Report use of cannabis an average of 1-7 days per week
- •Not currently seeking treatment for their cannabis use
- •Urine test positive for recent cannabis use for heavy users
- •No reported adverse effects with cannabis smoking in light users
- •Have a Body Mass Index from 18.5 - 34kg/m
- •Able to perform all study procedures
- •FEMALES: Currently practicing a non-hormonal effective form of birth control
- •FEMALES: Must be regularly cycling
排除标准
- •Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or cannabis use disorder
- •Report using other illicit drugs in the prior 4 weeks
- •History or current evidence of severe psychiatric illness or medical condition 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.
- •Current use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
- •Current pain
- •Insensitivity to the cold water stimulus of the Cold Pressor Test
- •FEMALES: using a hormonal contraceptive
研究组 & 干预措施
Low strength cannabis
Smoked Cannabis (~4% THC)
干预措施: Active Cannabis (Drug)
Placebo
Smoked Cannabis (~0% THC)
干预措施: Placebo Cannabis (Drug)
Higher strength cannabis
Smoked Cannabis (~10% THC)
干预措施: Active Cannabis (Drug)
结局指标
主要结局
Pharmacokinetics of THC and metabolites
时间窗: 5 hours
Plasma levels of THC, 11-OH-THC, and THCCOOH
Subject-rated drug effects
时间窗: 5 hours
Average and peak subjective ratings of drug effects associated with abuse liability as measured using visual analogue scales (VAS; 1-100mm).
Analgesia as measured using the Cold Pressor Test
时间窗: 5 hours
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
次要结局
- Drug reinforcement using the cannabis self-administration task(5 hours)
研究者
Ziva D. Cooper, PhD
Associate Professor
University of California, Los Angeles