Emotions, Dopamine, Brain and Body (EMBODY)

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

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

Study Overview

• Status: Recruiting
• Conditions: Emotions
• Intervention / Treatment: Drug: Placebo; Drug: Domperidon

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ignacio Rebollo, PhD; Phone Number: 2519 0049 33200 8; Email: ignacio.rebollo@dife.de
• Study Contact Backup: Name: soyoung park, Prof PhD; Phone Number: 2510 0049 33200 88; Email: soyoung.park@dife.de

Study Locations

• Germany
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14558
      • Recruiting
      • German Institute of Human Nutrition
      • Contact: Ignacio Rebollo; Phone Number: 2519 0049 33200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: Domperidone emotions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No