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

NCT02267304 | Completed Phase 2 DMC

• 2 other identifiers: C13-022013-003487-31
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Morphine/placebo/naxolone

EXPERIMENTAL

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

Naxolone/morphine/placebo

EXPERIMENTAL

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

placebo/naxolone/morphine

EXPERIMENTAL

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

Interventions

50 mL of sodium chloride (0,9%) DRUG

Morphine/placebo/naxolone; Naxolone/morphine/placebo; placebo/naxolone/morphine

Morphine 0,05mg/kg DRUG

Morphine/placebo/naxolone; Naxolone/morphine/placebo; placebo/naxolone/morphine

Naloxone 10mg DRUG

Morphine/placebo/naxolone; Naxolone/morphine/placebo; placebo/naxolone/morphine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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")

You may not qualify if:

• 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, …

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CIC Neurologie GHPS

Paris, 75013, France

Location

MeSH Terms

Interventions

Sodium Chloride; Naloxone

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jean -Christophe Corvol, MCU-PH

  CIC Neurologie GH Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 17, 2014
• Study Start: October 30, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 30, 2016
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

FR (1)