Sex- and AGE-dependent Effects of Smoked and Oral Delta-9-THC
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of THC and metabolites
研究概览
简要总结
This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.
详细描述
The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year)
- •Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening
- •Not currently seeking treatment for their cannabis use
- •No reported clinically significant adverse effects with cannabis use
- •Have a Body Mass Index from 18.5 - 34kg/m2
- •Able to perform all study procedures
- •FEMALES: Currently practicing an effective form of birth control if pre-menopausal
排除标准
- •Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder
- •Report using other illicit drugs in the prior 4 weeks
- •Evidence of severe psychiatric illness (e.g. mood disorder with functional impairment or suicide risk, schizophrenia) or medical condition (i.e., hypertension) 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 predominant licit use of medical cannabis
- •Current use of prescription or regular use of over the counter medications (with the exception of hormonal contraceptives and hormone replacement therapy). Current use of herbal supplements that may affect study outcomes or interact with study drug (i.e., St Johns wort, kava, L-tryptophan, melatonin)
- •If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process are not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures
- •Current pain
- •Pregnancy is exclusionary due to the possible effects of the study medication on fetal development
- •History of an allergic reaction or adverse reaction to cannabis is exclusionary.
- •Currently enrolled in another research protocol
- •Not using a contraceptive method (hormonal or barrier methods)
- •The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
- •Intolerance to lactose and sesame (ingredients in the oral THC preparation)
- •Insensitivity to the Cold Pressor Test
研究组 & 干预措施
Placebo Comparator: Placebo
Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
干预措施: Smoked Placebo (Drug)
Placebo Comparator: Placebo
Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC)
干预措施: Oral Placebo (Drug)
Experimental: Low strength cannabis
Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
干预措施: Cannabis (Drug)
Experimental: Low strength cannabis
Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC)
干预措施: Oral Placebo (Drug)
Experimental: Higher strength cannabis
Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
干预措施: Cannabis (Drug)
Experimental: Higher strength cannabis
Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC)
干预措施: Oral Placebo (Drug)
Experimental: Low strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
干预措施: Dronabinol (Drug)
Experimental: Low strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (10 mg THC)
干预措施: Smoked Placebo (Drug)
Experimental: Higher strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
干预措施: Dronabinol (Drug)
Experimental: Higher strength oral THC
Smoked Cannabis (0 mg THC) Oral THC (20 mg THC)
干预措施: Smoked Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of THC and metabolites
时间窗: 6 hours
Plasma levels of THC, 11-OH-THC, and THCCOOH
Analgesia as measured using the Cold Pressor Test
时间窗: 6 hours
Peak and average pain threshold and tolerance assessed using the Cold Pressor Test
Subject-rated drug effects
时间窗: 6 hours
Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm).
Impairment
时间窗: 6 hours
The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score
次要结局
未报告次要终点
研究者
Ziva D. Cooper, PhD
Professor / Director
University of California, Los Angeles