Memory DisordersMEMOMORPHNCT03507985
Attention and Memory Disorders Related to Acute Morphine
An observational study of Memory Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of the study is to determine if there are attention disorders related to acute morphine use in single-traumatized patients and after that the investigators will determine whether there are immediate memory problems associated with acute morphine withdrawal in single-traumatized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Memory Disorders
- What is being tested?
- Two tests evaluating memory and attention
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Nov 2019
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Two groups of patients : The exposed group where patients receive morphine analgesia The unexposed group where patients receive stage 1 +/- 2 analgesia is non-opioid analgesics.
Who may be able to join
- Patients over 18
- Mono traumatized (suspicion of bone fracture) without vital distress, neurological, cardio-circulatory or pulmonary involvement
- Analgesia obtained, defined by a pain score on a numerical scale ≤ 3/10 at the end of the treatment
- Patient to be re-convened for plaster repair, control radiography or specialized consultation in the month following inclusion.
- Patients presenting in an emergency department of Toulouse University Hospital
Who cannot join
- Patients with vital distress, whatever the cause,
- Traumatized cranial,
- pre-existing labeled attention disorders (eg, diagnosed hyperactivity),
- Pre-existing memory disorders labeled (eg, dementia)
- Use of opioid analgesics other than morphine in the care of these patients
- Chronic opiate users (licit or illicit)
Show all 9Show fewer
- Psychiatric disorders
- Acute alcohol poisoning, voluntary drug poisoning or not, acute intoxication by drugs
- Visual disorders (colorblind ..), patients who can not read
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Vincent Bounes, MD, 05 67 69 16 76 ext. 33, bounes.v@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
The aim of the study is to determine if there are attention disorders related to acute morphine use in single-traumatized patients and after that the investigators will determine whether there are immediate memory problems associated with acute morphine withdrawal in single-traumatized patients.
From a biochemical point of view, the analgesic effects of morphine and the central side effects appear to be two different dimensions of the action of morphine, each related to a metabolite. Regarding acute attention, it is difficult to differentiate attention deficit disorder due to pain or due to morphine.
Two tests have been validated in the literature to evaluate attention and memory: the 15 words of Rey and the Stroop Color Word test. The investigators will use these two tests in this study.
Read the detailed description
Morphine is a powerful analgesic used in chronic non-neuropathic cancerous (Walsh) and non-cancerous (Zenz et al) pain and for the relief of acute trauma pain, for example.
It is know that morphine as well as pain can cause cognitive disorders but the pain seems to slow down the reaction time whereas morphine has an action on the long-term memory (Lorenz J et al). According to an experimental study on rats, low dose morphine (equivalent to that present in the human brain) does not cause long-term memory problems, as opposed to a higher dose. In healthy volunteers, a single dose of morphine gives little cognitive and psychomotor dysfunction (Hank et al). After 12 months of taking oral morphine, no cognitive dysfunction is detected, with even some improvement for some functions related to stopping pain. More recently, it has been shown that long-term morphine use causes spatial memory disturbances and that these are probably due to extracellular adenosine accumulation.
This work suggests that acute morphine could lead to memory and attention disorders. This would therefore result in intrinsic impairment of the cognitive abilities of the patient and thus an alteration of his understanding in the explanations given concerning a possible surgical intervention, the risks and benefits of it.
The purpose of the study is to assess the patient's attention and memory skills after acute morphine use. In order to know their initial capacities, the tests are also done remotely outside the influence of the analgesic drugs given to the emergency services. The two practical tests, the Stroop Color Word Test and Rey's 15-word test, are easily performed tests in an emergency context and validated in the literature.
- Conditions
- Memory Disorders
- Being tested
- Two tests evaluating memory and attention
- Keywords
- morphine, attention disorders
- Medical subject headings
- Memory Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two tests evaluating memory and attentionOther
The patient will perform two tests assessing memory and attention:
Regarding attention, the test used will be the Stroop Color Word Test, developed to measure visual selective attention, cognitive flexibility and inhibition.
For memory, the test used will be Rey's 15 words test. It provides an indicative standard for the evaluation of episodic verbal memory and learning abilities. This test was compared to the 16-item (18) free recall / booster test in normal aging and Alzheimer's dementia, and although it was more difficult, it . Since it allowed for the classification of participants from both groups without overlap
| Study group | Role | What they receive |
|---|---|---|
| The exposed group | The exposed group where patients receive morphine analgesia The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later. Receives: Other: Two tests evaluating memory and attention | |
| The unexposed group | The unexposed group where patients receive 1 +/- 2-stage analgesia is non-opioid analgesics.
The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later. Receives: Other: Two tests evaluating memory and attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of acute attention deficit according to the exposed or unexposed patient.
The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient.
For each patient, the investigators will calculate the percentage of deficit between the Stroop Color Word test result at inclusion and at follow-up divided by the tracking score. This acute deficit is expressed as a percentage.
The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient.
Measured: 1 month
Secondary outcomes (1)
The comparison of the acute memory deficit according to the exposed or unexposed nature of the patient
The secondary endpoint chosen is the comparison of the acute memory deficit according to the exposed or unexposed nature of the patient.
For each patient, the aim is to calculate the percentage of deficit between the test result of the 15 words of Reys test at inclusion and during the follow-up divided by the tracking score. This acute deficit is expressed as a percentage.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startSep 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Bounes, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507985
- Sponsor's protocol ID
- RC31/18/0144
- Other IDs
- 2018-A00991-54
- Acronym
- MEMOMORPH
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention and Memory Disorders Related to Acute Morphine
- ClinicalTrials.gov ID
- NCT03507985
- Acronym / sponsor ID
- MEMOMORPH / RC31/18/0144
- Conditions
- Memory Disorders
- Keywords
- morphine, attention disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Apr 2018 (actual)
- 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 study is to determine if there are attention disorders related to acute morphine use in single-traumatized patients and after that the investigators will determine whether there are immediate memory problems associated with acute morphine withdrawal in single-traumatized patients.
From a biochemical point of view, the analgesic effects of morphine and the central side effects appear to be two different dimensions of the action of morphine, each related to a metabolite. Regarding acute attention, it is difficult to differentiate attention deficit disorder due to pain or due to morphine.
Two tests have been validated in the literature to evaluate attention and memory: the 15 words of Rey and the Stroop Color Word test. The investigators will use these two tests in this study.
Detailed description
Morphine is a powerful analgesic used in chronic non-neuropathic cancerous (Walsh) and non-cancerous (Zenz et al) pain and for the relief of acute trauma pain, for example.
It is know that morphine as well as pain can cause cognitive disorders but the pain seems to slow down the reaction time whereas morphine has an action on the long-term memory (Lorenz J et al). According to an experimental study on rats, low dose morphine (equivalent to that present in the human brain) does not cause long-term memory problems, as opposed to a higher dose. In healthy volunteers, a single dose of morphine gives little cognitive and psychomotor dysfunction (Hank et al). After 12 months of taking oral morphine, no cognitive dysfunction is detected, with even some improvement for some functions related to stopping pain. More recently, it has been shown that long-term morphine use causes spatial memory disturbances and that these are probably due to extracellular adenosine accumulation.
This work suggests that acute morphine could lead to memory and attention disorders. This would therefore result in intrinsic impairment of the cognitive abilities of the patient and thus an alteration of his understanding in the explanations given concerning a possible surgical intervention, the risks and benefits of it.
The purpose of the study is to assess the patient's attention and memory skills after acute morphine use. In order to know their initial capacities, the tests are also done remotely outside the influence of the analgesic drugs given to the emergency services. The two practical tests, the Stroop Color Word Test and Rey's 15-word test, are easily performed tests in an emergency context and validated in the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The exposed group | – | Other: Two tests evaluating memory and attentionThe exposed group where patients receive morphine analgesia The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later. |
| The unexposed group | – | Other: Two tests evaluating memory and attentionThe unexposed group where patients receive 1 +/- 2-stage analgesia is non-opioid analgesics. The patient will realise two tests evaluating memory and attention, for the first at the inclusion visit after giving his consent, and in a second time during the follow up visit 15 days or 1 month later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Two groups of patients : The exposed group where patients receive morphine analgesia The unexposed group where patients receive stage 1 +/- 2 analgesia is non-opioid analgesics.
Key inclusion criteria (5 listed)
- Patients over 18
- Mono traumatized (suspicion of bone fracture) without vital distress, neurological, cardio-circulatory or pulmonary involvement
- Analgesia obtained, defined by a pain score on a numerical scale ≤ 3/10 at the end of the treatment
- Patient to be re-convened for plaster repair, control radiography or specialized consultation in the month following inclusion.
- Patients presenting in an emergency department of Toulouse University Hospital
Key exclusion criteria (9 listed)
- Patients with vital distress, whatever the cause,
- Traumatized cranial,
- pre-existing labeled attention disorders (eg, diagnosed hyperactivity),
- Pre-existing memory disorders labeled (eg, dementia)
- Use of opioid analgesics other than morphine in the care of these patients
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 |
|---|---|---|
| Two tests evaluating memory and attentionThe patient will perform two tests assessing memory and attention: Regarding attention, the test used will be the Stroop Color Word Test, developed to measure visual selective attention, cognitive flexibility and inhibition. For memory, the test used will be Rey's 15 words test. It provides an indicative standard for the evaluation of episodic verbal memory and learning abilities. This test was compared to the 16-item (18) free recall / booster test in normal aging and Alzheimer's dementia, and although it was more difficult, it . Since it allowed for the classification of participants from both groups without overlap | Other | The exposed group, The unexposed group |
Primary outcome
The comparison of acute attention deficit according to the exposed or unexposed patient.
Time frame: 1 month
The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient. For each patient, the investigators will calculate the percentage of deficit between the Stroop Color Word test result at inclusion and at follow-up divided by the tracking score. This acute deficit is expressed as a percentage. The primary endpoint selected is the comparison of acute attention deficit according to the exposed or unexposed patient.
1 secondary outcome
The comparison of the acute memory deficit according to the exposed or unexposed nature of the patient
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Vincent Bounes, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Disorders, run by University Hospital, Toulouse 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 9 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Bounes, MD (05 67 69 16 76 ext. 33, bounes.v@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of acute attention deficit according to the exposed or unexposed patient. (time frame: 1 month). 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 11 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.