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临床试验/NCT03809546
NCT03809546已完成早期 1 期

Differential Female Response to Δ9-tetrahydrocannabinol (THC): The Influence of Estradiol

University of Chicago1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月6日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Change From Baseline in Profile of Mood States (POMS)

研究概览

简要总结

Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-35 years old, females (N=60)
  • Body Mass Index 19-26
  • High school education, fluent in English
  • Occasional cannabis users ( <11 times in past 30 days)

排除标准

  • History of daily cannabis use
  • Past or present severe substance use disorder
  • Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
  • Past year major depression
  • Current or past Post Traumatic Stress Disorder
  • Attention Deficit Hyperactivity Disorder
  • Cardiovascular illness, high blood pressure, abnormal electrocardiagram
  • Current medications (NO hormonal birth control or intrauterine device)
  • Pregnant or planning to become pregnant

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: dextrose (Drug)

7.5 mg THC

Active Comparator

干预措施: Dronabinol (Drug)

15 mg THC

Active Comparator

干预措施: Dronabinol (Drug)

结局指标

主要结局

Change From Baseline in Profile of Mood States (POMS)

时间窗: Difference from baseline (time 0 or pre-capsule) to post-capsule (120 min)

The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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