Cognitive Impact of Paracetamol in Healthy Volunteers (ICP)

January 26, 2012 updated by: University Hospital, Clermont-Ferrand
Randomized study, double-blind, crossover, controlled versus placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Paracetamol impact on cognitive processes has been until recently little studied in literature that presents conflicting results. Some authors do not describe any cognitive performance change (Bradley and Nicholson, 1987) but more recent studies (Ishida et al., 2007) report an interesting performance improvement in therapeutic doses of paracetamol.

This improved performance would use the serotonergic pathway that is involved in the analgesic mechanism of paracetamol as the investigators demonstrated in our laboratory on previous work (Pickering et al. 2006, 2008). However, non-therapeutic dose, instead, showed a deterioration of memory processes in animals which may be link to implication of Cyclooxygenases COX-2. Indeed, several studies have demonstrated (Sharifzadeh et al. 2005; Teather et al., 2005) that anti COX-2 (such as Celebrex) cause in animal a deleterious effect on memory, while an anti COX1 and 2 (as indomethacin) or an anti COX1 (as piroxicam) lead to no change. A dose-effect relationship is therefore suggested on animals. Furthermore, a recent study in healthy volunteers showed that paracetamol acts not only on pain but also on pain / stress in society in everyday life (" social pain ") (deWall et al., 2010). By fMRI, these psychologists have shown that the reduction of "social" pain is associated with a decrease in neuronal activity in brain regions that are involved in social processes but also those who are involved in pain processes (anterior cingulate cortex , anterior insula etc..). They also showed that paracetamol known for its painkillers properties may reduce the painful feelings of rejection or shelved in everyday life. The cognitive-emotional impact of paracetamol is even more interesting that the investigators now know that its metabolism could involve cannabinoids receptors, particularly CB1 in hippocampus and association cortex involved themselves in cognitive phenomena.

INSERM U766 team to which the investigators belong has proposed the following sequence from preclinical : 1) metabolism of acetaminophen in analgesic metabolite AM404 via FAAH enzyme, 2) AM404 acts indirectly on CB1 receptors, 3) strengthening of bulbo spinal descending pathways by the endocannabinoid system, 4) involvement of serotonergic receptors pain suppressors.

This protocol follows a pilot that the investigators completed (HOP clinicaltrial.gov NCT01053650, unpublished results yet) where the investigators studied the impact of 2g of paracetamol in healthy volunteers. The investigators showed a memory improvement, but with no placebo group, it has not been possible to conclude a significant impact of oral paracetamol. Thus, this protocol will allow us to better understand if paracetamol can affect some cognitive processes, particularly vigilance, memory and decision making.

In addition, the investigators will build a biological collection to assess the pharmacogenetic profile of subjects and, in a secondary objective, correlate it to cognitive characteristics of subjects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy volunteers,
  • aged over 18 years and not more than 25 years,
  • males,
  • free from any treatment in the 7 days preceding inclusion especially no use of analgesics or anti-inflammatories

Exclusion Criteria:

  • Contraindications to the administration of paracetamol
  • medical and/or surgical history judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
  • evolutionary pathology at review for inclusion
  • excessive intake of alcohol, tobacco (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assess cognitive impact of taking paracetamol within healthy volunteers by comparing the results on cognitive tests Cantab® between two passages, in particular a memory test (SOC)
Time Frame: after the results on cognitive tests Cantab
after the results on cognitive tests Cantab

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assess cognitive impact of taking paracetamol on other cognitive tests Cantab® (understanding : MOT and DMS, reaction time : RTI, visual memory : PRM, decision making : IST)
Time Frame: after an other cognitive test Cantab
after an other cognitive test Cantab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-0095
  • 2011-000662-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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