pain perception healthy subjects
Conditions
Interventions
Group 1: Control group: placebo pill with no active ingredient on day 1
Group 2: Group levodopa/carbidopa 100/25 mg orally once on day 1
Group 3: Group sulpiride 400 mg orally once on day 1
Sponsors
Klinische Neurowissenschaften und translationale Schmerzforschung, Universitätsmedizin Essen, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Given informed consent to participation in the study
Exclusion criteria
Exclusion criteria: Exclusion criteria are the presence of any acute or chronic somatic or mental diseases, including several chronic pain conditions, abuse of illegal substances or alcohol, regular use of medication (except thyroid medication, allergy medication, occasional use of over-the-counter analgesics, and contraception); hypersensitivity, contraindications, allergy, or intolerance to any ingredients of the study medication; pregnancy or breastfeeding; and/or insufficient German language proficiency. Participants must not have taken part in studies using investigational drugs within the past three months and shall refrain from eating two hours prior to the experimental sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modulation of placebo analgesia on day 2. This is expressed as the interaction effect between experimental condition (placebo vs. control) and medication group (sulpiride vs. levodopa vs. control) on pain perception, which is assessed on a visual analogue scale from 0-100. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint no 1: Placebo analgesia on day 8. This is expressed as the main effect of experimental condition (placebo vs. control) on pain perception, which is assessed on a visual analogue scale from 0-100. Secondary endpoint no 2: Modulation of placebo analgesia on day 8. This is expressed as interaction effect between experimental condition (placebo vs. control) and medication group (sulpiride vs. levodopa vs. control) on pain perception, which is assessed on a visual analogue scale from 0-100. Secondary endpoint no 3: Modulation of treatment expectation concerning the placebo cream. This is expressed as interaction effect between medication group (sulpiride vs. levodopa vs. control) and rating timepoint (day 1 before conditioning vs. day 2 before testing) on treatment expectation as measured by the "Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects (GEEE)". Exploratory outcomes are genetic analyses (via saliva sample), symptoms of drug side effects (Generic Assessment of Side Effects in Clinical Trials (GASE), Somatosensory Amplification Scale (SSAS - German version), Perceived Stress Scale (PSS-10 - German version), state & trait variables of anxiety and depression (State-Trait-Anxiety-Depression-Inventory State (STADI), Fear of Pain Questionnaire (FPQ-III, German version), Pain Catastrophizing Scale (PCS, German version) [4] Behavioral Inhibition System (BIS), Behavioral Approach System (BAS), 10-item-Big-Five-Inventory (BFI-10). Exploratory outcomes are investigated by a dedicated umbrella project of the collaborative research centre (CRC 289). | — |
Countries
Germany
Contacts
Public ContactAngelika Kunkel
Klinische Neurowissenschaften und translationale Schmerzforschung, Universitätsmedizin Essen, Klinik für Neurologie
Outcome results
None listed