The impact of inflammation on the extinction of pain-related fear

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016706

Enrollment

100

Registered

2019-02-21

Start date

2018-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Group 1: Endotoxin (Escherichia coli O113:H10), i.v., 0.4 ng/kg body weight Group 2: Physiological saline (0.9% NaCl), i.v.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy subjects, body mass index (BMI) >19 and <30, non-smokers

Exclusion criteria

Exclusion criteria: Acute oder chronic inflammation, infectious diseases, gastrointestinal diseases, hepatic and liver diseases, cardiovascular diseases, hematological disorders, respiratory diseases, diabetes and other metabolic disorders, adipositas, psychiatric disorders, addiction. Regular drug intake, pain medication, participation in clinical pharmacoligical studies. Additional exclusion criteria for women: hormonal contraception, pregnancy, nursing

Design outcomes

Primary

Measure	Time frame
Assessment of perceived CS and US unpleasantness, perceived CS-US contingency, and US intensities during acquisition, extinction and reinstatement using visual analogue scales; assessment the fear response by electrodermal activity (skin conductance); measurement of brain neural activity (BOLD response) during aquisition, extinction and reinstatement using functional MRI	—

Secondary

Measure	Time frame
Quantification of pro- and anti-inflammatory cytokines as well as cortisol und norepinephrine in plasma/serum before (baseline) as well as 1, 2, 3, 4, 6 and 24 hours after administration of endotoxin/placebo; assessment of mood, sleepiness, and sickness behavior before (baseline) as well as 1, 2, 3, 4, 6 and 24 hours after administration of endotoxin/placebo using standardized questionnaires: State Trait Anxiety Inventory (STAI), State Trait Anxiety Depression Inventory (STADI), Profile of Mood States (POMS), Stanford Sleepiness Scale (SSS), Sickness Score; brain structure and connectivity	—

Measure

Time frame

Quantification of pro- and anti-inflammatory cytokines as well as cortisol und norepinephrine in plasma/serum before (baseline) as well as 1, 2, 3, 4, 6 and 24 hours after administration of endotoxin/placebo; assessment of mood, sleepiness, and sickness behavior before (baseline) as well as 1, 2, 3, 4, 6 and 24 hours after administration of endotoxin/placebo using standardized questionnaires: State Trait Anxiety Inventory (STAI), State Trait Anxiety Depression Inventory (STADI), Profile of Mood States (POMS), Stanford Sleepiness Scale (SSS), Sickness Score; brain structure and connectivity

—

Countries

Germany

Contacts

Public ContactRobert Pawlik

Universitätsklinikum Essen,Institut für Medizinische Psychologie und Verhaltensimmunbiologie

robert.pawlik@uk-essen.de0201/723-83497

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026