HealthyPhase 2MBBAnalgesicNCT02267304
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Morphine and Naloxone on Motivation (MBBAnalgesic)
A Phase 2 study testing 50 mL of sodium chloride (0,9%), Morphine 0,05mg/kg and Naloxone 10mg in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 50 mL of sodium chloride (0,9%), Morphine 0,05mg/kg and Naloxone 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2013to 30 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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")
Who cannot join
- 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
Show all 14Show fewer
- 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, …
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- 50 mL of sodium chloride (0,9%), Morphine 0,05mg/kg, Naloxone 10mg
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mL of sodium chloride (0,9%)Drug
Morphine 0,05mg/kgDrug
Naloxone 10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Morphine/placebo/naxolone | Experimental | Not described Receives: Drug: 50 mL of sodium chloride (0,9%); Drug: Morphine 0,05mg/kg; Drug: Naloxone 10mg |
| Naxolone/morphine/placebo | Experimental | Not described Receives: Drug: 50 mL of sodium chloride (0,9%); Drug: Morphine 0,05mg/kg; Drug: Naloxone 10mg |
| placebo/naxolone/morphine | Experimental | Not described Receives: Drug: 50 mL of sodium chloride (0,9%); Drug: Morphine 0,05mg/kg; Drug: Naloxone 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 min after first placebo injection, 15 min after morphine (respectively naloxone) injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start30 Oct 2013
- Primary completionAug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean -Christophe Corvol, MCU-PH, Principal investigator, CIC Neurologie GH Pitié Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267304
- Sponsor's protocol ID
- C13-02
- Other IDs
- 2013-003487-31
- Acronym
- MBBAnalgesic
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2014
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02267304
- Acronym / sponsor ID
- MBBAnalgesic / C13-02
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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")
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Cost Accumulation Slope (AU.)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean -Christophe Corvol, MCU-PH principal investigator
CIC Neurologie GH Pitié Salpêtrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mL of sodium chloride (0,9%), Morphine 0,05mg/kg and Naloxone 10mg in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Accumulation Slope (AU.) (time frame: 15 min after first placebo injection, 15 min after morphine (respectively naloxone) injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.