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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02267304

Acronym

MBBAnalgesic

Enrollment

Registered

2014-10-17

Start date

2013-10-30

Completion date

2016-08-30

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers

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).

Interventions

DRUG50 mL of sodium chloride (0,9%)

DRUGMorphine 0,05mg/kg

DRUGNaloxone 10mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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, …

Design outcomes

Primary

Measure	Time frame	Description
Cost Accumulation Slope (AU.)	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026