Buspirone for Functional Dysphagia

Study Overview
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Brief Summary
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This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.

Detailed Description
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Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry). Our two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills. We hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.

Official Title
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Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia

Conditions
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Functional Dysphagia, Ineffective Esophageal Motility

Intervention / Treatment
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* Drug: Buspirone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction Esophageal biopsies negative for eosinophilic esophagitis Exclusion Criteria: Pregnant women Prisoners Currently on other serotonin modulating medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone then Placebo<br>Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks | Drug: Buspirone<br> <br> * Other names: Buspar;Drug: Placebo<br>* Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic<br>|
| Experimental: Placebo then Buspirone<br>Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks. | Drug: Buspirone<br> <br> * Other names: Buspar;Drug: Placebo<br>* Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry | DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal. | Change in the score from Baseline to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score | A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD). | Change in the score from Baseline to 14 days | 
| Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. | A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg | 14 days |