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临床试验/NCT04794205
NCT04794205撤回1 期

Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary

Hartford Hospital1 个研究点 分布在 1 个国家开始时间: 2021年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Changes in self-rating for pain following ingestion of BCP.

研究概览

简要总结

Beta-Caryophyllene is an essential oil and cannabis plant derivative also found in edible herbs. It has shown promise as a potential analgesic in preclinical trials. However, there are no human studies characterizing pharmacokinetics of BCP in humans. Therefore, it is of great importance to determine the pharmacokinetics of BCP in humans so that appropriate dosing can be developed for analgesia. This pharmacokinetic work will lay the groundwork for subsequent experiments testing the neural mechanism of BCP on pain.

详细描述

Chronic pain conditions are among the most common reasons adults seek medical care. Given the abuse potential for opioid analgesics, a substantial number of individuals with chronic pain have turned to alternatives such as medical marijuana. There is increasing evidence that medical marijuana has potential benefits for pain related conditions, but it also carries unwanted side effects such as impaired cognition and motor skills that may linger long after use, social stigma, and a moderate potential for abuse. Much of the marijuana/pain research is predicated on the assumption that its potential analgesic effects are due to its primary psychoactive ingredient - delta-9-tetrahydrocannabinol (THC). However, marijuana also contains dozens of phytochemicals, including cannabinoids and terpenes. Accordingly, there is interest in characterizing potential pain-relieving effects of these non-intoxicating constituents of marijuana. Thus far, it is unclear which components may be most relevant for influencing pain, or the mechanisms by which they exert their effects. Betacaryophyllene (BCP) may be a possible candidate because it is isolatable, has shown evidence as a potential analgesic in preclinical research, is known to be safe for human administration, and there is a strong premise for believing it interacts with the neurobiological systems in the brain that process pain.

This project was conceptualized to advance our mechanistic understanding of the analgesic potential of BCP in humans. The study will be a randomized, placebo-controlled, double-blind study of the pharmacokinetic mechanisms of BCP, including dosing and duration of action, and its potential analgesic effect on thermal pain induction following single-oral dosage. Ten healthy participants will be screened and on each of four subsequent visits will be dosed with either 5 mg, 30 mg, 150 mg of BCP or placebo. Participants' sensitivity to thermal pain induction will be measured before and after administration of the drug using a self survey of pain level. Successful completion of the project may elucidate the potential analgesic effects of ingesting beta-caryophyllene in humans, which can lead to new forms of treatment for pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females of all races and ethnicities.
  • 18/50 yrs old.
  • Medically healthy (as determined by medical history and treatment).
  • No current substance abuse disorder
  • Adequate comprehension of English in order to complete study materials.
  • Able and willing to provide written informed consent, and willing to commit to the study protocol.

排除标准

  • Estimated premorbid intellectual disability <80 (WRAT-4)
  • Neurological or medical disorder that may affect brain function.
  • Comorbid DSM-V diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months
  • Vulnerable populations (e.g. pregnant, nursing, incarcerated); unwillingness to use reliable means of contraception.
  • High risk for suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded.
  • Current homicidal ideation with plan and intent such that outpatient care is precluded.
  • Positive result on urine toxicology test for any substance, including CBD
  • Any current acute or chronic pain condition
  • Current use of any pain prescribed ROTC medications including opioids, NSAIDs, acetaminophen etc.
  • Initial detection of abnormal liver function tests or CBC (see below)
  • Initial detection of significant EKG abnormality

研究组 & 干预措施

Low Dose BCP

Experimental

Subjects will receive low dose of BCP.

干预措施: Low Dose Beta-Caryophyllene (Drug)

Medium Dose BCP

Experimental

Subjects will receive a medium dose of BCP

干预措施: Medium Dose Beta-Caryophyllene (Drug)

High Dose BCP

Experimental

Subjects will receive high dose of BCP.

干预措施: High Dose Beta-Caryophyllene (Drug)

Placebo

Experimental

Subjects will receive placebo drug.

干预措施: Placebo (Drug)

结局指标

主要结局

Changes in self-rating for pain following ingestion of BCP.

时间窗: Once immediately prior to drug administration; post drug administration at 1 and 2 hours.

Participants will rate sensitivity to thermal pain induction using a visual analog scale post administration of BCP. The scale is titled "Thermal Pain Visual Analog Scale" and has values from 0 to 10 with 0 being the least painful and 10 being the most painful.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Godfrey Pearlson

Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Yale University

研究点 (1)

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