跳至主要内容
临床试验/NCT01665573
NCT01665573已完成早期 1 期

Cannabinoid Augmentation of Fear Response in Humans

Yale University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2012年7月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
31
试验地点
1
主要终点
Galvanic skin response

研究概览

简要总结

The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 65
  • Male and female
  • No major medical problems

排除标准

  • Hearing problems
  • Psychiatric or mental problems

研究组 & 干预措施

PF-04457845

Active Comparator

Acquisition of conditioning Administration of drug Extinction of conditioning

干预措施: PF-04457845 (Drug)

PF-04457845

Active Comparator

Acquisition of conditioning Administration of drug Extinction of conditioning

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: PF-04457845 (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Galvanic skin response

时间窗: Test days #1, #2, and #3, on average a week

Measure of sympathetic autonomic activation

Cortisol levels measured in blood

时间窗: Test days #1, #2, and #3, on average a week

Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.

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

Mohini Ranganathan

Assistant Professor

Yale University

研究点 (1)

Loading locations...

相似试验