High Potency Cannabis: Acute and Protracted Effects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 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 effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
详细描述
This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with ~50 mg and ~100 mg THC compared to placebo (~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.
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 smoking near daily
- •Not currently seeking treatment for their cannabis use
- •Have a Body Mass Index from 18.5 - 34kg/m
- •Able to perform all study procedures
- •Must be using a contraceptive (hormonal or barrier methods)
排除标准
- •Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine
- •Do not have positive urine toxicology for cannabis use during screening
- •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 predominant licit use of medical cannabis, prescription analgesics, or any medications that may affect study outcomes
- •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
High dose THC
100 mg THC
干预措施: High dose THC (Drug)
Low dose THC
50 mg THC
干预措施: Low dose THC (Drug)
Placebo Comparator: Placebo
0 mg THC
干预措施: Placebo Comparator: Placebo (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)
次要结局
- Pharmacokinetics of THC and metabolites(3 hours)
研究者
Ziva D. Cooper, PhD
Professor
University of California, Los Angeles