Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

Empathy Clinical Trial

— MEAD  

Official title:

Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424420
• Other study ID #: 2018-004187-60
• Status: Recruiting
• Phase: Phase 1
• Start date: November 7, 2019
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: University of Göttingen
• Contact: Jürgen Brockmöller, Prof.
• Phone: +49 (0) 551 39-53 11
• Email: jbrockm[@]gwdg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Empathy

Intervention

Drug:
• Paracetamol
Paracetamol oral tablet
• Ibuprofen
Ibuprofen oral tablet
• Placebo oral tablet
Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Locations

Country	Name	City	State
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Jürgen Brockmöller	University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of paracetamol and ibuprofen on social pain and empathy	Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.	8 hours
Primary	Effect of paracetamol on social pain and empathy	Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.	14 days
Secondary	Psychological effects of paracetamol and ibuprofen	Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test.	8 hours
Secondary	Pharmacokinetics effects of paracetamol and ibuprofen	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).	8 hours
Secondary	Pharmacogenes roles in paracetamol and ibuprofen metabolism	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.	8 hours
Secondary	Psychological effects of paracetamol	Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test.	14 days
Secondary	Pharmacokinetics effects of paracetamol	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).	14 days
Secondary	Pharmacogenes roles in paracetamol metabolism	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.	14 days