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

Universitaire Ziekenhuizen KU Leuven10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

BuspironeDRUG

Administration of buspirone to assess esophageal sensitivity

PlaceboDRUG

Administration of placebo to assess differences in esophageal sensitivity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in sensitivity to thermal stimulation

To detect changes in thermal stimulation for sensitivity

Time frame: After 30 minutes after administration buspirone

Secondary Outcomes

Change in sensitivity to mechanical stimulation

To detect changes in mechanical stimulation for sensitivity

Time frame: After 45 minutes after administration buspirone

Change in sensitivity to electrical stimulation

To detect changes in electrical stimulation for sensitivity

Time frame: After 60 minutes after administration buspirone

Change in sensitivity to chemical stimulation

To detect changes in chemical stimulation for sensitivity

Time frame: After 75 minutes after administration buspirone

Change in positive and negative affect score

to detect change in affect of the multimodal stimulation

Time frame: 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

Time frame: At the beginning of the study and at the end of the multimodal stimulation

Data from ClinicalTrials.gov

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