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Clinical Trials/NCT02267304
NCT02267304
Completed
Phase 2

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 site in 1 country37 target enrollmentOctober 30, 2013

Overview

Phase
Phase 2
Intervention
50 mL of sodium chloride (0,9%)
Conditions
Healthy
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
37
Locations
1
Primary Endpoint
Cost Accumulation Slope (AU.)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
October 30, 2013
End Date
August 30, 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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")

Exclusion Criteria

  • 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

Arms & Interventions

Morphine/placebo/naxolone

Intervention: 50 mL of sodium chloride (0,9%)

Morphine/placebo/naxolone

Intervention: Morphine 0,05mg/kg

Naxolone/morphine/placebo

Intervention: Naloxone 10mg

Morphine/placebo/naxolone

Intervention: Naloxone 10mg

Naxolone/morphine/placebo

Intervention: 50 mL of sodium chloride (0,9%)

Naxolone/morphine/placebo

Intervention: Morphine 0,05mg/kg

placebo/naxolone/morphine

Intervention: 50 mL of sodium chloride (0,9%)

placebo/naxolone/morphine

Intervention: Morphine 0,05mg/kg

placebo/naxolone/morphine

Intervention: Naloxone 10mg

Outcomes

Primary Outcomes

Cost Accumulation Slope (AU.)

Time Frame: 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.

Study Sites (1)

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