Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

Study Overview
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Brief Summary
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To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.

Official Title
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Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Buspirone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HV aged between 18 - 60 years Exclusion Criteria: history of psychiatric disease or a positive first degree psychiatric family history pregnancy or lactation concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …) medication affecting esophageal motility significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic) prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure history of gastrointestinal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buspirone<br>Buspirone 20 mg per oral | Drug: Buspirone<br>* Administration of buspirone to assess esophageal sensitivity<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Administration of placebo to assess differences in esophageal sensitivity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensitivity to thermal stimulation | To detect changes in thermal stimulation for sensitivity | After 30 minutes after administration buspirone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensitivity to mechanical stimulation | To detect changes in mechanical stimulation for sensitivity | After 45 minutes after administration buspirone | 
| Change in sensitivity to electrical stimulation | To detect changes in electrical stimulation for sensitivity | After 60 minutes after administration buspirone | 
| Change in sensitivity to chemical stimulation | To detect changes in chemical stimulation for sensitivity | After 75 minutes after administration buspirone | 
| Change in positive and negative affect score | to detect change in affect of the multimodal stimulation | At the beginning of the study and at the end of the multimodal stimulation | 
| Change in state trait and anxiety score | to detect changes in the score due to the multimodal stimulation | At the beginning of the study and at the end of the multimodal stimulation |