Status:
COMPLETED
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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-makin...
Eligibility Criteria
Inclusion
- 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
- 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, …
Key Trial Info
Start Date :
October 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02267304
Start Date
October 30 2013
End Date
August 30 2016
Last Update
August 26 2021
Active Locations (1)
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1
CIC Neurologie GHPS
Paris, France, 75013