Buspirone for Functional Dysphagia

NCT ID: NCT02674412

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-04-12

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.

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.

Conditions

Functional Dysphagia; Ineffective Esophageal Motility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buspirone then Placebo

Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Placebo then Buspirone

Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Interventions

Buspirone

Intervention Type: DRUG

Placebo

Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Intervention Type: DRUG

Other Intervention Names

Buspar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Scott Gabbard, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 15-544

Identifier Type: -

Identifier Source: org_study_id