Emotions, Dopamine, Brain and Body

Study Overview
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Brief Summary
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The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI

Official Title
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Influence of Domperidon on the Experience of Emotions, Brain and Bodily Activity

Conditions
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Emotions

Intervention / Treatment
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* Drug: Domperidon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 18-40 years old men and women Consent to participate Fluent in German Physically and mentally healthy. No regular medication BMI 18-25 kg/m2 Alcohol consumption less than 15 glasses a week (wine / beer, a glass of higher-percentage alcohol counts as two glasses of beer) No illegal drug consumption in the week previous to the experiment No smoking No extreme athletes No vegetarians or vegans or any other dietary restrictions due to allergies or intolerances Normal day-night rhythm (no shift work) Exclusion criteria Former or current illnesses of: Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities) Heart or blood circulation Gastro-intestinal or endocrine disorders Other serious past or present medical conditions (for example, metabolic syndrome, diabetes). Current medication and medication over a period of two weeks prior to the examination. Other serious health problems or present strong mental or physical stress. No current infection or excessive stress Missing consent to receive information about incidental findings from the MRI Tendency to claustrophobia, dizziness or panic attacks. Wear a non-removable pacemaker, defibrillator, hearing aid, drug pump, neurostimulator or implant with solenoid valve (e.g., artificial bowel outlet). Metal parts or implants inside the body, for example, due to surgery or injury with a metallic foreign object (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coil, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents). Have non-removable metal parts or metal-containing devices on or in the body. Have ferromagnetic metal parts or implants inside the body (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coils, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents) Wearing magnetically fixed implants (e.g., amalgam fillings, glass eye). Professionally or privately being involved in the processing of metals. Have large tattoos (whole limbs). Being pregnant. Wear a intra-uterine device. Having tinnitus. Hypersensitivity or allergy to Domperidone or common excipients (lactose-1, corn Starch, potato starch, microcrystalline cellulose, castor oil, povidone, sodium lauryl sulfate, magnesium stearate, hypromellose)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Double blind, placebo controlled intervention with 20mg of Domperidon
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Domperidon<br>Participants recieve 10mg of Domperidon, 45 minutes before the start of the experiment | Drug: Domperidon<br>* oral<br>|
| Placebo Comparator: Placebo<br>Participants recieve a placebo pill, 45 minutes before the start of the experiment | Drug: Placebo<br>* oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain responses to emotions | fMRI brain responses to emotional videos comparing placebo vs domperidon condition. Specifically: dampened brain response to disgust and high arousing videos in domperidon condition | 1-3 hour after drug administratrion | 
| Body (stomach, heart, skin conductance) response to emotions | Physiological responses to emotional videos comparing placebo vs domperidon condition. Specifically: Reduction in Tachyhastria for disgust and high arousing videos in domperidone condition | 1-3 hour after drug administratrion | 
| Behavioral responses to emotions | Changes in subjective reports to emotional videos comparing placebo vs domperidon condition. Specifically: Reduction in disgust and arousal ratings to disgust and high arousing videos | 1-3 hour after drug administratrion |