Buspirone for Functional Dysphagia

NeuroTherapia, Inc.

Status: Completed

Conditions: Ineffective Esophageal Motility; Functional Dysphagia

Treatments: Drug: Buspirone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02674412

IRB 15-544

Details and patient eligibility

About

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 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Buspirone then Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Buspirone

Placebo then Buspirone

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Buspirone