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OpenTrials
Completed

NCT Number: NCT04352686

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

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

Completed

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buspirone

Drug

Administration of buspirone to assess esophageal sensitivity

Placebo

Drug

Administration of placebo to assess differences in esophageal sensitivity

Primary outcomes

  1. Change in sensitivity to thermal stimulation

    Time frame: After 30 minutes after administration buspirone

    To detect changes in thermal stimulation for sensitivity

Secondary outcomes

  1. Change in sensitivity to mechanical stimulation

    Time frame: After 45 minutes after administration buspirone

    To detect changes in mechanical stimulation for sensitivity

  2. Change in sensitivity to electrical stimulation

    Time frame: After 60 minutes after administration buspirone

    To detect changes in electrical stimulation for sensitivity

  3. Change in sensitivity to chemical stimulation

    Time frame: After 75 minutes after administration buspirone

    To detect changes in chemical stimulation for sensitivity

  4. Change in positive and negative affect score

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

    to detect change in affect of the multimodal stimulation

  5. Change in state trait and anxiety score

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

    to detect changes in the score due to the multimodal stimulation

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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