Clinical trial NCT02267304: Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-10-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


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
* 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, ...

Primary outcomes:
measure: Cost Accumulation Slope (AU.)
timeFrame: 15 min after first placebo injection, 15 min after morphine (respectively naloxone) injection
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC Neurologie GHPS
Study officials:
affiliation: CIC Neurologie GH Pitié Salpêtrière
name: Jean -Christophe Corvol, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References: