healthy male and female volunteers
Conditions
Interventions
Group 1: single injection of endotoxin (E.coli, 0113:H10
i.v., 0.8 ng/kg body weight) to induce an acute systemic inflammation
single administration of an anti-inflammatory drug (Ibuprofen, per os, 600mg), verbal manipulation of treatment expectation (positive)
Group 2: single injection of endotoxin (E.coli, 0113:H10
single administration of an anti-inflammatory drug (Ibuprofen, per os, 600mg), verbal manipulation of treatment expectation (neutral)
Group 3: single injection of endotoxin (E.coli, 0113:H10
single administration of an inert substance (Placebo pill, per os), verbal manipulation of treatment expectation (positive)
Group 4: single injection of endotoxin (E.coli, 0113:H10
single administration of an inert substance (Placebo pill, per os), verbal manipulation of treatment expectation (neutral)
Sponsors
Universitätsklinikum Essen, Institut für Medizinische Psychologie und Verhaltensimmunbiologie
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: healthy male and female volunteers aged 18-50
Exclusion criteria
Exclusion criteria: acute/ chronic physical diseases (e.g. gastrointestinal disorders, liver/ kidney diseases, cardiovascular diseases, diabetes mellitus, obesity); pathological laboratory values (e.g. CRP); regular use of medications (except for oral contraception); contraindications for ibuprofen intake; evidence of mental disorders according to DSM-V criteria based on validated screening tools (especially depression, anxiety disorders); MRI-specific exclision criteria (phobic anxiety, claustrophobia, ferromagnetic implants, etc.); women: pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sickness symptoms (bodily and psychological sickness symptoms), assessed with standardized questionnaires (STADI, STAI, GASE, MDBF, KSS); pressure pain thresholds (PPT), assesed with a digital Algometer; emotion processing, assessed with a spatial cueing paradigm (Emotional Posner Task). All Parameter will be repeatedly assessed before (baseline), as well as 1,2,3,4,6 and 24 hours (questionnaires) or 2 (Emotional Eosner Task) or 3 (PPT) hours after LPS injection respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| repeated measurement of the following parameters (baseline as well as 1,2,3,4,6, and 24 hours after LPS injection): Plasma/ Serum/ Saliva concentrations of pro-/ anti-inflammatory cytokines and neuroendocrine parameters, B- and T-cell-function (cytokine secretion, proliferation), blood pressure, heart rate, body temperature. measurement of the following moderator and predictor variables during visits before the experimental day: psychological trait characteristics, coping, attitude towards drugs, treatment expectation, using standardized questionnaires; functional and structural imaging data (diffusion tension imaging, DTI; resting state activity). in addition: salivary cortisol awakening response and alpha-amylase activity on two consecutive days before the experimental day. | — |
Countries
Germany
Outcome results
None listed