Empathy
Conditions
Keywords
Mental effects, Social Pain
Brief summary
The objective of the present study is to study paracetamol effects on social pain and empathy under standardized international conditions (ICH-GCP) for planning, conduction and reporting of clinical pharmaceutical studies in humans. The study included MRI imaging of brain activity, analysis of genomic biomarkers potentially explaining interindividual variation. It is controversial whether the effects are of immediate nature or develop during a period of about 10 days. Therefore, the study is separated into two study phases. Single dosing (SD) is applied in study phase 1 and multiple-dosing (MD) in study phase 2. The study compares paracetamol with placebo and in the study phase 1 also with ibuprofen as analgetically active control.
Interventions
DRUGParacetamol
Paracetamol oral tablet
DRUGIbuprofen
Ibuprofen oral tablet
DRUGPlacebo oral tablet
Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.
Sponsors
University Hospital Ulm
Prof. Jürgen Brockmöller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective with placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent obtained prior to study. 2. Willingness to meet the study instructions and to co-operate with the study personal. 3. No clinically relevant pathological findings in any of the investigations at the screening visit; minor deviations of laboratory values from the normal range may be accepted if judged by the investigator to have no clinical relevance. 4. Body weight not less than 48 kg and body mass index (BMI) not less than 17 kg/m² and not greater than 32 kg/m².
Exclusion criteria
1. Pacemaker devices, implantable or external ones. 2. Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department). 3. Known pregnancy or lactation period. 4. History of alcohol and / or drug abuse and / or any abusive use of medicaments. 5. Any disease affecting liver or kidney or impairment of the liver or kidney-function. 6. History of severe hypersensitivity reactions, anaphylaxis, psychiatric or neurologic disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of paracetamol and ibuprofen on social pain and empathy | 8 hours | Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale. |
| Effect of paracetamol on social pain and empathy | 14 days | Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacogenes roles in paracetamol and ibuprofen metabolism | 8 hours | Genetic analysis of relevant genes responsible for paracetamol and ibuprofen Absorption, Distribution, Metabolism and Excretion (ADME).Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects. |
| Psychological effects of paracetamol | 14 days | Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test. |
| Psychological effects of paracetamol and ibuprofen | 8 hours | Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test. |
| Pharmacogenes roles in paracetamol metabolism | 14 days | Genetic analysis of relevant genes responsible for paracetamol Absorption, Distribution, Metabolism and Excretion (ADME). Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects. |
| Pharmacokinetics effects of paracetamol | 14 days | Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax). |
| Pharmacokinetics effects of paracetamol and ibuprofen | 8 hours | Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax). |
Countries
Germany
Contacts
Primary ContactJürgen Brockmöller, Prof.
Backup ContactJohannes Matthaei, Dr.med.
Outcome results
None listed