Buspirone for Functional Dysphagia

• ClinicalTrials.gov Identifier: NCT02674412
• Recruitment Status: Completed
• First Posted: February 4, 2016
• Results First Posted: August 10, 2018
• Last Update Posted: August 10, 2018
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Scott Gabbard, MD, The Cleveland Clinic

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Functional Dysphagia; Ineffective Esophageal Motility	Drug: Buspirone; Drug: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: April 12, 2017
• Actual Study Completion Date: April 12, 2017

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Buspirone; Other Name: Buspar; Drug: Placebo; Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
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.	Drug: Buspirone; Other Name: Buspar; Drug: Placebo; Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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).
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

  Study Documents (Full-Text)

Documents provided by Scott Gabbard, MD, The Cleveland Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] August 10, 2016

More Information

• Responsible Party: Scott Gabbard, MD, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02674412
• Other Study ID Numbers: IRB 15-544
• First Posted: February 4, 2016
• Results First Posted: August 10, 2018
• Last Update Posted: August 10, 2018
• Last Verified: June 2018

Additional relevant MeSH terms:

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Buspirone; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action