Buspirone for Functional Dysphagia

Overview

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.

Full Title of Study: “Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 12, 2017

Detailed Description

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.

Interventions

  • Drug: Buspirone
  • Drug: Placebo
    • Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Arms, Groups and Cohorts

  • Experimental: Buspirone then Placebo
    • Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
  • Experimental: Placebo then Buspirone
    • Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
    • Time Frame: Change in the score from Baseline to 14 days
    • 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.

Secondary Measures

  • Change in Gastroesophageal Reflux Disease – Health Related Quality Questionnaire Score
    • Time Frame: Change in the score from Baseline to 14 days
    • 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 Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.
    • Time Frame: 14 days
    • A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott Gabbard, MD, MD – The Cleveland Clinic

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