Emotions, Dopamine, Brain and Body (EMBODY)

German Institute of Human Nutrition

Status and phase: Enrolling; Phase 4

Conditions: Emotions

Treatments: Drug: Domperidon; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06171087

Domperidone emotions

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Domperidon

Active Comparator group

Description:

Participants recieve 10mg of Domperidon, 45 minutes before the start of the experiment

Treatment:

Drug: Domperidon

Placebo

Placebo Comparator group

Description:

Participants recieve a placebo pill, 45 minutes before the start of the experiment

Treatment:

Drug: Placebo