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临床试验/NCT02267304
NCT02267304已完成2 期

Etude Comparative Monocentrique, randomisée, en Cross Over, en Double Aveugle, Contre Placebo, de l'Action de la Morphine et de la Naloxone Dans un modèle Cognitif de Gestion Des Efforts Physiques

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2013年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Cost Accumulation Slope (AU.)

研究概览

简要总结

The aim of the current study is to examine the role of the opioïd system on the cognitive parameters of motivation. They are embedded in a conceptual framework of motivation that merges decision-making and reinforcement learning theories. Every action is conceived as path from one state to another. The different states are associated to different values (positive for rewards and negative for punishments), and the different actions to different costs (risk, effort and delay). The tasks are designed such that the sensitivity to the state and action parameters can be inferred by fitting computational models.The primary objective is to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on cost accumulation slope, assessed in an effort management task, in which participants are asked to squeeze a hand grip during 30 seconds at varying level of effort in order to win monetary payoff. Secondary objectives are to characterize the effect of Morphine 0,05mg/kg and Naloxone 10mg on other cognitive parameters of motivation (assessed with a motivational battery that includes rating, choice and learning tasks).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •Man or woman, age ≥ 18 and < 50
  • •Weight between 50 kg and 90 kg.
  • •No contraindication to effort
  • •No evolutive pathology that could interfere with the current study signed consent
  • •medical insurance ("sécurité sociale")

排除标准

  • •Age < 18 or > 50
  • •Person under curatorship, or guardianship, or with civil rights deprivation
  • •History of neurologic or psychiatric pathology
  • •Chronic or actual consumption of alcohol, or psychotropic drugs
  • •pregnancy, breastfeeding
  • •Woman of childbearing potential without effective contraception
  • •Liver failure
  • •Severe Cardiovascular Disorders
  • •Severe Cerebrovascular Discorders
  • •Morphine (or Naloxone) hypersensitivity/addiction
  • •Treatment contraindicated: morphine dérivatives, neuroleptics, barbiturate, benzodiazepine, anxiolytics, hypnotics, antidepressant, antihistamine, antihypertensives, beta blocker, baclofen, thalidomide
  • •Enzyme inducers, (rifampicine, ...)
  • •Treatment that can interfere with the performance of the subject: beta2 adrenergic agonists, analgesics, corticosteroïds, anti-inflammatory drugs, ...

研究组 & 干预措施

Morphine/placebo/naxolone

Experimental

干预措施: 50 mL of sodium chloride (0,9%) (Drug)

Morphine/placebo/naxolone

Experimental

干预措施: Morphine 0,05mg/kg (Drug)

Morphine/placebo/naxolone

Experimental

干预措施: Naloxone 10mg (Drug)

Naxolone/morphine/placebo

Experimental

干预措施: Naloxone 10mg (Drug)

Naxolone/morphine/placebo

Experimental

干预措施: 50 mL of sodium chloride (0,9%) (Drug)

placebo/naxolone/morphine

Experimental

干预措施: 50 mL of sodium chloride (0,9%) (Drug)

Naxolone/morphine/placebo

Experimental

干预措施: Morphine 0,05mg/kg (Drug)

placebo/naxolone/morphine

Experimental

干预措施: Naloxone 10mg (Drug)

placebo/naxolone/morphine

Experimental

干预措施: Morphine 0,05mg/kg (Drug)

结局指标

主要结局

Cost Accumulation Slope (AU.)

时间窗: 15 min after first placebo injection, 15 min after morphine (respectively naloxone) injection

The primary Outcome measure is the change in this parameter between the placebo condition and the morphine (respectively naloxone) condition.This parameter will be infered from the time spent in a effort period versus a rest period within trials of an effort managing task, for each subjects.

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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