Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: 50 mL of sodium chloride (0,9%)
* Drug: Morphine 0,05mg/kg
* Drug: Naloxone 10mg


Participation Criteria
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Eligibility Criteria
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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 Smokers 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, …

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine/placebo/naxolone<br> | Drug: 50 mL of sodium chloride (0,9%)<br> <br> Drug: Morphine 0,05mg/kg<br> <br> Drug: Naloxone 10mg<br> <br> |
| Experimental: Naxolone/morphine/placebo<br> | Drug: 50 mL of sodium chloride (0,9%)<br> <br> Drug: Morphine 0,05mg/kg<br> <br> Drug: Naloxone 10mg<br> <br> |
| Experimental: placebo/naxolone/morphine<br> | Drug: 50 mL of sodium chloride (0,9%)<br> <br> Drug: Morphine 0,05mg/kg<br> <br> Drug: Naloxone 10mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Accumulation Slope (AU.) | 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. | 15 min after first placebo injection, 15 min after morphine (respectively naloxone) injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers